CordisS.M.A.R.T.® andS.M.A.R.T.® CONTROL™

Nitinol SystemFor the Iliac Arteries

A Patient’s Guide toPeripheral VascularDisease in theIliac Arteries

Endovascular

this guidebook...

1

TThis guidebook is proudly broughtto you and your family by CordisCorporation.

If you or a member of your familyhas been diagnosed with peripheralvascular disease (PVD), you may have

questions aboutthe disease andits treatment,especially if yourdoctor hasrecommendedangioplasty andpossible stentimplantation.

This guidebook answers some of thequestions patients with peripheralvascular disease often ask.

NOTE. The contents of this patientbrochure are applicable to boththe Cordis S.M.A.R.T.® CONTROL™

Nitinol Stent System and the CordisS.M.A.R.T.® Nitinol Stent System.Both will be referred to as theCordis S.M.A.R.T.® Stent System inthis brochure.

Introduction . . . . . . . . . . . . . . . . . . 3

Peripheral Vascular Disease . . . . . .3Risk Factors . . . . . . . . . . . . . . . . . 5

The Iliac Arteries . . . . . . . . . . . . . . .5Iliac Artery Narrowing(Stenosis) . . . . . . . . . . . . . . . . . . . 6Diagnosis . . . . . . . . . . . . . . . . . . .6

Treatment Options . . . . . . . . . . . . 7

The Cordis S.M.A.R.T.® Stent Systemfor Iliac Arteries . . . . . . . . . . . . . . 10

Preparing for Your ProcedureBefore Your Procedure . . . . . . 12Risk of the Procedure . . . . . . . .13The Angioplasty Procedure . . . . . . . . . . . . . . . . . .16Stent Implantation Procedure . . . . . . . . . . . . . . . . . .18After Your Procedure . . . . . . . .19Precautions . . . . . . . . . . . . . . . .20

Your Recovery . . . . . . . . . . . . . . . .21Lifestyle Changes . . . . . . . . . . . 23

Conclusion . . . . . . . . . . . . . . . . . . 24

Glossary . . . . . . . . . . . . . . . . . . . . 25

Contact Information . . . . . . . . . . .30

this guidebookanswers

questionspatients with

often ask

some of the

PVD

table of contents

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TThis guidebook is designed tohelp you and your familyunderstand peripheral vasculardisease (PVD) and treatmentwith a vascular stent. If youhave any questions as you read,

please writethem downand discussthem withyour doctoror nurse.

introduction

PPeripheral vascular disease iscaused by the build-up of fattysubstances that collect andadhere to the linings of thearteries, in a process known asatherosclerosis. You may alsohear the terms “plaque”,“blockage”, “lesion”, or“stenosis”. As the build-upcontinues, the internal liningof the artery thickens whichcauses the artery to narrowand limit blood flow to vitaltissues and organs.

peripheral vasculardisease

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SSome of the more commonlyaffected arteries are thosewhich are located in thelegs, arms, neck and kidneys.The symptoms from theseblockages depend on whatartery is affected and theseverity of the blockagecausing limited blood flow.

• A dull, cramping pain in thehips, thighs, buttock or calfmuscles (claudication).

• Numbness/tingling in the leg,foot or toes

• Changes in skin color suchas paleness or bluish color inleg, foot, or toes

• Changes in skin temperatureof leg, foot or toes

• Ulceration or gangrene dueto sores that have not healed

• Uncontrolled high bloodpressure (hypertension)

• Kidney damage (renal failure)

Some of the symptomsyou may experience inthe affected areas are:

peripheral vasculardisease (continued)

4

YYou are at the greatest risk forperipheral vascular disease if you:

• Are diabetic• Are obese• Smoke• Have high blood pressure• Have a family history of

the disease• Are inactive• Have coronary artery

disease• Have high cholesterol

peripheral vascular disease - risk factors

AArteries are vessels that carryblood away from the heart.The iliac arteries extendfrom the bottom of theaorta and then branch intosmaller arteries carryingoxygen-rich blood to thepelvis and legs.

The iliac arteries

extend from the

bottom of the

aorta and branch

into smaller vessels

the iliac arteries

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Aorta

PelvisIliacArteries

WWhen atheroscleroticplaque builds up inthe iliac arteries,they begin tonarrow and restrictblood flow to thepelvis and legs. Thisis called iliac arterystenosis. Severe iliacartery stenosis can

lead to complete blockage andloss of function.

iliac artery narrowing(stenosis)

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diagnosis

PPatients should be screened foriliac artery stenosis if they have:

Pain in legs with exertion orwalking which is relievedwith rest.Diminished leg pulses orother abnormal sounds of blood flow heard through a stethoscope placed over the iliac arteries.Slow wound healing on legs.

The following diagnostic testsmay be performed if iliac arterydisease is suspected.

Iliac artery ultrasound: A sound-wave test that produces animage of iliac arteries onto ascreen. This test allows the sizeof the vessel to be measuredand the flow of blood to thepelvis and legs to be tracked.This can be helpful in identifyingnarrowing in the iliac arteries.This test is painless and does notrequire the use of needles, dyeor x-rays.

•

•

•

AAngiography: An angiogram isan x-ray test obtained byinjecting dye through a smalltube (catheter) inserted intoan artery in the groin or arm.This procedure will determineexactly where the narrowingis located and will help toguide further treatments.You will be awake for the test,although you may be given alight sedative. The injection ofdye is expected to cause awarm sensation and you mayget a metallic taste in yourmouth. After the test iscomplete you will need to lieflat for 5 – 6 hours to allowthe puncture site in the arm orgroin to heal.

diagnosis (continued)

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treatment options

TThere are four basic treatmentoptions for patients with iliacartery stenosis.

Diet Modification andExercise: Decreasing theamount of fat and cholesterolin your diet in combinationwith walking exercises are thecornerstones of treating iliacartery stenosis. Your doctorwill make specific dietary andexercise recommendations foryou. Other life style changesmay also need to be made,especially the discontinuationof smoking.

1.

MMedical Management:Medicine can be prescribed tohelp dilate the blood vessel inyour legs in order to improveblood flow. Additionally,medications that help to loweryour cholesterol and fats maybe prescribed. If you havediabetes, your physician mayrecommend modifications tomedications to help reduceyour blood sugar levels.

Iliac Artery Bypass Surgery:A man-made graft, one ofyour own veins, or a syntheticmaterial will be used to act asa detour to create newchannels to carry blood to thepelvis and legs.

Iliac Artery BalloonAngioplasty and Stenting:This procedure uses a smalltube (catheter) with a smallballoon on the end to openthe narrowed iliac artery bycompressing the plaqueagainst the vessel wall. Thisprocess reduces the narrowinguntil it no longer interfereswith blood flow. The balloonis deflated and removed fromthe artery.

treatment options (continued)

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2.

3.

4.

IIliac Artery BalloonAngioplasty and Stenting:(continued)In most cases, a stent, which is ametallic wire-mesh tube, is thenplaced into the opened artery.The size of a stent used is about1 1/2 inch in length and 1/2 inchin diameter when fullyexpanded in the artery. Whenexpanded, the stent acts as abrace to keep the artery open,restoring normal blood flow.

Over severalweeks, thehealthy innerlining of theartery will growover the stent,permanentlyincorporating itinto the vessel.

In a clinical investigation,patients with iliac arterystenosis received the CordisS.M.A.R.T.® CONTROL™ NitinolStent System. After ninemonths, 3.5 percent of thecases evaluated had a 50percent or more re-narrowingor blockage of their iliac artery.

treatment options (continued)

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TThe Cordis S.M.A.R.T.® StentSystem for iliac arteries ismade of a metal alloy callednitinol (nickel titanium). Thestent is contained in a deliverysystem for passage into thebody to the iliac arteries.

The CordisS.M.A.R.T.®

Stent Systemshould onlybe used byphysicianswho aretrained inangioplasty and stentplacement. You may wish toask your doctor about his orher experience with this stentand the procedure used for itsplacement.

If you are pregnant, speak toyour doctor about this beforeundergoing the angioplasty orstent placement procedure.

Cordis S.M.A.R.T.® Stent Systemfor Iliac Arteries

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Be sure to ask your doctor to explainthe risks and benefits of your treatmentoptions and answer any questions youor your family may have.

Cordis S.M.A.R.T.® Stent System

PPatients with one or more of thefollowing characteristics mightnot be suitable candidates forstent placement:

• Poor kidney function or severe high blood pressure

• History of low number of white blood cells, low number of platelets, or significant low number of red blood cells

• Allergy or sensitivity to nitinol (nickel titanium alloy)

It is importantto inform yourdoctor aboutyour entiremedical history,which includesall medicationsyou arepresentlytaking.

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Cordis S.M.A.R.T.® Stent Systemfor Iliac Arteries (continued)

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UUpon admission to thehospital, you usually will haveundergone tests such as iliacartery ultrasound,angiography and routineblood tests. Be sure to tellyour doctor what medicationsyou are currently taking andany allergies you might have.You will probably be asked notto eat or drink anything aftermidnight on the night beforeyour procedure. You may beasked to take aspirin for oneto two days prior to theprocedure. If you are apatient who requires the useof medications called antacidsor H-2 antagonists, pleaseensure that your doctor isaware of this. Your doctor willbe able to advise you whetheror not to stop this medication.

The procedure will beperformed in a c a t h e t e r i z a t i o nlaboratory or a radiology suite.You will lie on an x-ray table,and a x-ray camera (f l u o r o s c o p e)will move over your bodyduring the procedure. Yo u rheart and blood pressure willbe monitored during thep r o c e d u r e .

before your procedure

BBe sure that your doctor hasdiscussed the procedure in detailwith you in addition to theapproximate time theprocedure takes. The possiblerisks and benefits will beexplained to you and anyquestions you have should beanswered.

The procedure itself usuallyinvolves little to moderate painin addition to the discomfortusually experienced during thefirst few hours followingangioplasty. During theprocedure, you may be injectedwith the same dye you weregiven during the previousangiogram you might havereceived. Although rare, dyeinjection may produce anallergic type reaction causinglow blood pressure andbreathing difficulties.

risks of the procedure

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risks and benefitswill be explainedto you and any

questionsyou have should beanswered

TThe angioplasty procedureyou will undergo may involvepossible risks. These risksinclude, but are not limited to:

• Bleeding at the access (puncture) site in your groinor arm

• Bruising, swelling at the puncture site

• Rupture of the iliac artery (dissection)

• Excessive bleeding (hemorrhage)

• Infection/fever• Abnormal blood-filled

dilation of an artery (aneurysm)

• Recurrence of the blockage (restenosis)

• Reaction to dye(contrast media)

• Plaque dislodgment• Clot formation• Stroke• Unexpected limb loss• Nerve damage (peripheral

neuropathy)• Heart attack (myocardial

ischemia/infarction)• Death

risks of the procedure (continued)

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TThe risks associated with stentimplantation include all risks listedon the previous page with theaddition of the following:

• Increased risk of clot formation• Movement of the stent• Allergic reaction to the metal of

the stent• Damage to the iliac artery• Failure to deliver the stent to

the site of the blockage• Persistent vessel spasm• Expansion of one or more

layers of the vessel wall (pseudoaneurysm)

• Dislodgment of the stent into your arterial circulation and it becoming permanently wedged itself into a small branch vessel in your body

risks of the procedure (continued)

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YYour procedure will be performedin a room equipped with specialinstruments and x-ray equipment.Once you enter this room, you willbe moved onto an x-ray table.You will be covered with sterilesheets and the area where thecatheter will be inserted (groin,arm, or wrist) will be shaved andwashed with an antisepticsolution to prevent infection.

A numbing medication (localanesthetic) will be used at the sitewhere the catheter is inserted.You may feel a stinging sensationduring the administration of themedication. After the medicationtakes effect, you should only feeldull pressure where the doctor isworking with the catheters. If theinsertion is made in your innerthigh, a small tube called a sheathwill be inserted into the vessel.The balloon catheter will then beplaced through the sheath. If yourincision is made in your arm orwrist, a guiding catheter will beinserted into the artery andadvanced to the iliac arteries. Dyeinjected through the catheter willallow the doctor to see the areaof blockage in your vessels.

the angioplastyprocedure

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AAn x-ray machine called afluoroscope with a TV screen allowsthe doctor to see your vessels andthe catheter as it is moved forwardin your vessel. Your doctor may askyou to take a deep breath and holdit for a few seconds. When thecatheter reaches the diseased areato be treated, a tiny balloon on thetip of the catheter will be inflated.The balloon applies pressure to theplaque in the vessel, causing thevessel to open and increase bloodflow. It is normal to experiencesome pain during the ballooninflation. Please tell your doctorif you feel any pain during theprocedure.

You will be awake during yourprocedure. Your doctor or a hospitalmember may give you instructions.It is important to listen for theseinstructions and do what is asked.

the angioplastyprocedure (continued)

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Inflated balloon catheter applyingpressure to the vessel with plaque

TThe procedure for stent implantationis similar to a standard angiogramprocedure.

The Cordis S.M.A.R.T.® Stent System isintroduced into the iliac artery on acatheter-based delivery system andadvanced to the blocked area of theartery. The stent is self-expandingand will open to fit the artery. Oneor more stents may be implanted inthe iliac artery depending on theextent of the disease. The deliverysystem is withdrawn from the body,while the expanded stent(s)remain(s) in the iliac artery.

Your doctor may choose to furtherexpand the stent with a ballooncatheter similar to the one used inthe angioplasty procedure. Thisprocedure is called post-dilatationand ensures that the stent is infull contact with the vessel wall.The Cordis S.M.A.R.T.® Stent Systemstays in place permanently,holding the vessel open andimproving the flow of blood.

The angioplasty and stentprocedure will usually takeapproximately 60 to 90 minutes.

stent implantationprocedure

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Stented vessel

AAfter the procedure, you will bemoved to a special care unitwhere you will be closelymonitored by the hospital staff.Your blood pressure and heartrhythm will be monitoredcontinuously.

If your groin was used as an accesssite for the procedure, you canexpect to stay in bed for severalhours. The sheath will beremoved within six hours of theprocedure, but may be left inlonger if heparin, a medicationgiven during the procedure, iscontinued. While the sheath is inplace, and for about six hoursafter its removal, you will have tolie flat on your back, keeping thesheath straight and still. You willnot be allowed to bend your leg.As the sheath is removed, thedoctor or nurse will apply pressureto the puncture site for 20 – 30minutes, until the bleeding hasstopped. A sandbag may beplaced over the puncture site tokeep pressure on it.

after your procedure

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you will be

closely monitoredby the

hospital staff

S• Should you see or feel any bloodat the puncture site, notify the hospital staff immediately

• Do not try to sit up until your nurse or doctor asks you to do so

• It is important to lie flat and keep still preventing bleeding from your vessel

• If your arm was used for the procedure, you may be allowed to sit up afterwards, but you may be asked to stay in bed for several hours

• You may drink and eat foods that are light until you are fully able to sit upright. Drink all of the fluids that are offered to you. The fluids will help flush out the x-ray dye that was used during your procedure

• Your doctor may allow you to walk within 12-24 hours after your procedure, providing your puncture site is healing. A member of the hospital staff will be there to assist you

precautions

20

your doctor mayallow you

to walkwithin

12-24 hoursafter the procedure

BBefore you leave the hospital, yourdoctor will give you guidelines foractivity, diet and medications. Youwill be asked to avoid demandingactivities like heavy lifting for atleast a week. You will be advisedwhen you can resume normalactivity and return to work. Yourdoctor will prescribe medications foryou to take to prevent blood clotsfrom forming in your newly openedvessel. Please notify your doctor ifthese medications cause unpleasantreactions. Do not stop taking themunless your doctor advises you todo so. Different medications maybe prescribed that suit you better.

Patients who undergo angioplastyand stent implantation are usuallydischarged from the hospital thenext day. You should arrange tohave someone take you homerather than driving yourself. Afteryou leave the hospital your progresswill continue to be monitored bymedical personnel. It is importantto keep all of your scheduledfollow-up appointments.

your recovery

21

usually

dischargedfrom the hospitalthe next day

IIf you have any pain, discomfort orbleeding from your puncture site,call your doctor immediately. If yourdoctor cannot be reached, call 911to be taken to the nearest hospitalemergency room. You will also beasked to take aspirin. The amountof the dose will vary from 81 to 325mg/day and will need to be takenfor at least three months after yourprocedure. Your doctor will adviseyou about the exact amount ofaspirin you should be taking.

The healthy lining of the vessel willslowly grow over the stent,permanently incorporating it intothe vessel wall. You will not feel thestent and your daily activities willnot be affected. Patients who havehad a vascular stent implant shouldtell this to any doctor who treatsthem in the future.

If you require magnetic resonanceimaging (MRI), the stent does notinterfere with, nor is it affected by,the operation of an MRI device.

After stent placement, you will befollowed closely to monitor yourrecovery. An ultrasound, identicalto the one performed prior to theprocedure may be performedto determine if any narrowinghas occurred.

your recovery (continued)

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YYou and your doctor have formeda team in an effort to reduce therisk of restenosis (re-occurringblockage) in the area of yourstent.

To help yourself stay healthy inthe future, you are encouragedto make important diet, exerciseand lifestyle changes. Somepatients may need fewmodifications while others mayneed to make many changes.Those patients who are able toreduce the fats and cholesterol intheir diets are less likely toredevelop blockages in the stent.A low-fat, low-cholesterol diet canlower the levels of fat in yourblood and reduce your risk.Choosing to eat healthy foods inthe right proportions will alsohelp you to achieve and maintaina healthy weight.

In addition to a healthy diet, it isextremely important to avoidsmoking. If you need helpquitting, please notify yourhealthcare provider.

lifestyle changes

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YYou have a very important role toplay in order to ensure that yourangioplasty and stent implantationwill be successful. It is essentialthat you cooperate with yourdoctor and follow through withyour responsibilities as part of thepatient/medical team. Keep yourappointments and adopt a healthylifestyle. If you have any questionsor concerns, please contact yourdoctor to discuss them. It isimportant that you get the mostbenefit from your treatment andjoin the thousands of people withperipheral vascular disease who areleading healthy, productive lives.

conclusion

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adopt a

healthylifestyle

glossaryAngiogram: A procedure in whichcontrast dye is injected into thearteries to diagnose a narrowingor blockage of the artery.

Angioplasty: A procedurewhereby a dilation catheter ispassed through to the blockedarea of an artery. Once theballoon is inflated, the catheteropens the blocked area in theartery. Also called PercutaneousTransluminal Angioplasty (PTA).

Anticoagulant: A substance thatslows or prevents the clotting ofblood.

Antiplatelet: A medicine thatreduces the clumping of plateletsin the blood. An antiplateletmedicine helps thin the blood toprevent clot formation.

Atherosclerosis: The processof fatty deposits and/or calciumbuild-up (plaque) on the insideof the arteries.

Balloon Catheter: A tube used forgaining access to the arteries witha tiny balloon on its tip. Theballoon is gently inflated after thecatheter is in position.

Blood Vessel: An artery or vein.

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Catheter: A hollow tube used forgaining access to a blood vessel.

Catheterization: A procedure thatinvolves passing a tube (catheter)through blood vessels andinjecting dye to detect blockages.

Cholesterol: A substance thatcirculates in the blood and plays arole in the formation ofblockages. Cholesterol originatesin foods that are rich in animalfat.

Circulation: The movement ofblood through the vessels of thebody, which is produced by thepumping action of the heart,enabling the flow of nutrientsand oxygen through the body.

Claudication: Pain in the leg thatoccurs with work or exercise, butmay also occur when resting.

Contrast: X-ray dye used to viewthe arteries during an angiogram.

Diabetes: A disease affecting one’smetabolism of glucose (sugar)which causes changes in the bloodvessels. These changes may aid inthe development of peripheralvascular disease.

glossary

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Dilation Catheter: A catheter witha balloon on the end that can beinflated.

Doppler Ultrasound: A non-invasive test using sound waves todetermine the presence of arterialnarrowing.

Fluoroscope: Equipment used in acatheterization procedure thatcaptures a “motion picture” x-rayimage of the arteries.

Gangrene: Tissue death (necrosis),usually due to inadequate or lackof blood supply.

Guiding Catheter: A hollow tubethrough which fluids or objectscan be introduced or removedfrom the body.

Hypertension: High bloodpressure.

Lesion: A blockage in a bloodvessel. Also known as a plaque orstenosis.

Local Anesthetic: A substanceused to numb the area to which itis applied.

Lumen: The inner channel orcavity of a vessel or tube.

glossary

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MRI (Magnetic ResonanceImaging): A diagnostic test thatuses magnetic fields to obtainimages of the inside of your body.

Percutaneous: Performed througha small opening in the skin.

Peripheral Vascular Disease:Vascular disease which affects theblood vessels, especially those ofthe extremities.

Plaque: An accumulation or build-up of fatty deposits, calciumand/or cell debris in an artery thatleads to narrowing of the lumen.

Platelet Inhibitors: Medications toprevent blood cells called plateletsfrom sticking together andblocking the artery.

Restenosis: The recurrence of anarrowing or blockage in anartery after treatment.

Stenosis: A narrowing of anycanal, especially one of the iliacvessels.

Stent: An expandable, metallic,tubular shaped device thatprovides structural support for avessel.

Thrombus: A blood clot.

glossary

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Transluminal: Through the insideopening of an artery.

Triglycerides: Substances in theblood that are a component ofthe “bad” type of cholesterol.

Ulceration: The formation ordevelopment of an ulcer.

Vascular Closure Device: A deviceused to seal or close the arterypuncture after an angiogram orangioplasty. Made from eithercollagen plugs (special fiber thatseals the puncture site) or internalsutures (stitches).

Vascular System: The heart, blood,and network of blood vessels thatlead to and from the heart.

glossary

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Your doctor or nurse will reviewthis material with you. Weencourage you to ask them anyquestions regarding yourtreatment and recovery.

Additionally, your doctor mayrecommend that you join asupport group to speak withothers who have undergonesimilar procedures. Ask yourdoctor for contact informationabout these groups and possibleweb site addresses.

contact information

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Cordis S.M.A.R.T.® CONTROL™ Iliac Stent Indications for Use: • The improvement of luminal diameter in patients withsymptomatic atherosclerotic disease of the common and/or external iliac arteries.Contraindications: • There are no contraindications known at this time based onthe clinical data. Warnings/Precautions: Not recommended for patients with ahistory of contrast not amenable to pretreatment with steroids and/or antihistamines,or a hypersensitivity to Nitinol (nickel titanium).• Safety and effectiveness has notbeen demonstrated in patients with totally calcified or densely calcified lesions,uncontrollable hypercoaguability and/or other coagulapathy, pregnant women, orpediatric patients. • Use caution in patients with poor renal function who may be atrisk for contrast medium reaction. • Thrombus, distal embolization, or migration mayoccur if correct size stent is not used. • The device should only be used by physicianstrained in interventional techniques. • The long-term outcome following repeatdilatation of endothelialized stents is unknown at present. • With the exception ofstainless steel stents, do not implant different metal stents where overlap or contactwith the S.M.A.R.T. stent is possible. • Patients should receive appropriate antiplateletand anticoagulant therapy prior to the procedure. • Use only in conjunction withfluoroscopy. • Do not use with power injection system. • Do not use with Ethiodol orLipiodol contrast media. • Do not expose the delivery system to organic solvents (e.g.alcohol) • Do not re-sterilize and/or reuse the device. • The stent cannot be draggedor repositioned. • Do not attempt to recapture the stent once it is partially deployed.• Avoid stent placement that may obstruct access to a vital side branch. • Do notoverstretch the stent. • When treating multiple lesions, the most distal lesion shouldbe stented first followed by the stenting of proximal lesions. Overlap of sequentialstents is necessary but the amount of overlap should be kept to a minimum. • In theevent of complications such as infections, pseudoaneurysm or fistulization, surgicalremoval of the stent may be required. • Use caution when re-crossing a stent withadjunct devices. • In patients requiring the use of antacids and/or H2-antagonistsbefore or immediately after stent placement, oral absorption of antiplatelet agentsmay be adversely affected. • Antiplatelet therapy should be maintained for at leastthree months post-procedure.

Endovascular

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Cordis Endovascular is a division of Cordis Corporation© Cordis Corporation 2006 155-2284-1 5/06