The BeGraft study : a physician-initiatedstudy investigating the BeGraft peripheral

stentgraft in the iliac arteries :final 24-month results

Koen Deloose, MD

Head Vascular Surgery, AZ Sint Blasius,

Dendermonde, Belgium

2ID3 Medical – 2018 |

Disclosure slide

I have the following potential conflicts of interest to report:

Consulting: Medtronic, Spectranetics, Biotronik, Abbott, Bard

iVascular, Bentley, Cook, GE Healthcare, Terumo, Boston

Scientific, Contego Medical, B Braun

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

Speaker name: Koen Deloose, MD

3ID3 Medical – 2018 |

Is there a place/a need for stentgrafts in the iliac field?

4ID3 Medical – 2018 |

Is there a place/a need for stentgrafts in the iliac field?

5ID3 Medical – 2018 |

82.1%

53.0%

100% 87.0%

Chang et al. J Vasc Surg 2008;48:362-7 -

Are stentgrafts performing better in the iliac field?

0.00

0.25

0.50

0.75

1.00

24 18 16 11 Bare Stent Group

40 39 38 35 V12 Stent Group

Number at risk

1 6 12 18

Time (Months)

V12 Stent Bare Stent

Freedo

m f

rom

Bin

ary

Reste

no

sis

HR 0.136 (95% CI 0.042-0.442); p=0.0056

COBEST : Mwipatayi et al. J vasc Surg 2011;54:1561-70

Freedom from restenosisTASC C/D Group

6ID3 Medical – 2018 |

What about newer generations ?

Getinge Advanta V12 Bard Lifestream

Gore Viabahn BX InSitu Silene

Not CE marked

7ID3 Medical – 2018 |

What about newer generations ?

BeGraft (8x57mm)

Graft MaterialePTFE sleeve(203±25µm)

ePTFE film (110±10µm)

ePTFE ePTFE

Stent Material (Composition)

CoCr (L605) Stainless Steel Stainless Steel Stainless Steel

Stent Graft DesignSingle StentePTFE sleeve

clamped@stent ends

Film-Cast Encapsulation

Technology

Film-Cast Encapsulation

Technology

Film-Cast Encapsulation

Technology

SheathCompatibility

6F (8x57mm)7F

6F (6x22mm)7F

6F (7x37mm)7F (9x58mm)

8F

7F (8x59mm)8F

Guide Wire 0.035“ 0.035“ 0.035“ 0.035“

Crimped Profile 2.0 – 2.4mm 2.1 – 2.5mm n/a n/a

Advanta V12 LifeStream Viabahn BX

8ID3 Medical – 2018 |

Ideal combination crushresistance, low profile, flexibility

0,230,26

0,15

0,00

0,05

0,10

0,15

0,20

0,25

0,30

ADVANTA V12(Ø10 x 59mm)

BeGraftPeripheral (Ø10

x 57mm)

BardLIFESTREAM

(Ø10 x 58mm)

Rad

ial F

orc

e [N

/mm

]

2,532,41

2,71

0,00

0,50

1,00

1,50

2,00

2,50

3,00

ADVANTA V12(Ø10 x 59mm)

BeGraftPeripheral (Ø10 x

57mm)

BardLIFESTREAM

(Ø10 x 58mm)

Cri

mp

ed S

ten

t D

iam

ete

r [m

m]

BeGraft (8x57mm)

9ID3 Medical – 2018 |

• Prospective, non-randomized, multi-center study(70 patients)

• K. Deloose, M. Bosiers, J. Callaert - Sint-Blasius, Dendermonde• P. Peeters, J. Verbist, W. Vandeneynde - Imelda, Bonheiden• L. Maene, R. Beelen - OLV, Aalst• K. Keirse, B. Joos - Heilig Hart, Tienen

• Study objective:To evaluate the long-term safety & efficacy of the BeGraftPeripheral Stent Graft System (Bentley®)

BeGraft Peripheral PMCFStudy design

10ID3 Medical – 2018 |

BeGraft Peripheral PMCFIn/Exclusion Criteria

• Rutherford-Becker classification 2 to 5

• Stenotic/restenotic post POBA (≥50%) or occlusive lesions iliac arteries, categorized with a modified TASC-II classification

Exclusion of non-bifurcation aortic and/or CFA involvement

Exclusion of abdominal aneurysm presence

BeGraft Peripheral PMCFPrimary Endpoint

• Primary patency at 12 months, defined as:

Absence of restenosis (≥50% stenosis/ PSVR≥2.4) & without Target Lesion Revascularization (TLR) within 12 months

BeGraft Peripheral PMCFPatient demographics

N=70

Male (%) 45 (64.3%)

Age (min – max; ±SD) 65.04 (41– 91 ±10.01)

Nicotine abuse (%) 41(58.6%)

Hypertension (%) 46 (65.7%)

Diabetes mellitus (%) 14 (20.0%)

Renal insufficiency (%) 7 (10.0%)

Hypercholesterolemia (%) 41 (58.6%)

Obesity (%) 14 (20.0%)

Lesion side

Left (%) 26 (37.1%)

Right (%) 21 (30.0%)

Bilateral (%) 23 (32.9%) 93 lesions for 70 patients

Modified TASC II

TASC A TASC B TASC C TASC D

77,1%

14,3%

5,7% 2,9%

13ID3 Medical – 2018 |

BeGraft Peripheral PMCFLesion characteristics

N=93

Lesion length (min – max; ±SD) 34.3 mm (6.0 – 100.0; ±15.45)

Reference vessel diameter 7.96 mm

Mean lumen diameter 1.34 mm

Occlusion (%) 13 (14%)

Calcified lesion (%) 53 (57%)

14ID3 Medical – 2018 |

BeGraft Peripheral PMCF12 & 24 Month Primary Patency

Time baseline 1MFU 6MFU 12MFU 24MFU

at risk 93 92 83 71 47

% 100 98,9 96,8 94,4 92,40

92.40 %94.40 %

15ID3 Medical – 2018 |

BeGraft Peripheral PMCF12 & 24 Month Freedom from TLR

96.30 %

Time baseline 1MFU 6MFU 12MFU 24MFU

at risk 93 93 83 73 48

% 100 100 96,7 96,7 96,3

96.7 %

16ID3 Medical – 2018 |

BeGraft Peripheral PMCF12 & 24 Month Freedom StentGraft Occlusion

97.8 %

Time baseline 1MFU 6MFU 12MFU 24MFU

at risk 93 93 84 74 48

% 100 100 97,8 97,8 97,8

97,8 %

17ID3 Medical – 2018 |

BeGraft Peripheral PMCFClinical assessment & Safety

• No major amputations have been reported betweenbaseline & 24 MFU visit.

• 24 Month Limb Salvage Rate is 100%

18ID3 Medical – 2018 |

Conclusion

• Some evidence that stentgrafts in more complex TASC C&D lesions are performing better

• Time to study also newer generations of stentgrafts in theiliac field

• The Begraft stentgraft (Bentley) combines high crushresistance and high flexibility with low profile

• The Begraft PMCF study shows, although in relatively easy iliac lesions, outstanding results @ 24 months : PPR of 92.4%, f-TLR of 96.3% & f-SGO of 97.8%

The BeGraft study : a physician-initiatedstudy investigating the BeGraft peripheral

stentgraft in the iliac arteries :final 24-month results

Koen Deloose, MD

Head Vascular Surgery, AZ Sint Blasius,

Dendermonde, Belgium