BeGraft Peripheral PMCF Study: 12-month results

Deloose, Koen; Bosiers, Marc; Callaert, Joren; Peeters, Patrick; Verbist, Jürgen; Eynde, Wouter Van den; Maene, Lieven; Beelen, Roel; Keirse, Koen

doi:10.23736/s0021-9509.17.09916-5

Cited by 6 publications

(9 citation statements)

References 10 publications

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“…All but one patient completed the 12-month follow-up in study reported by Holden et al 32 (no mean follow-up provided); similarly, Deloose et al 27 reported outcomes through 12 months (no further follow-up statistics provided). c All patients completed the 6-month follow-up in this study (no mean follow-up provided).…”

Section: Comparison Of Devices a Comparison Of The Results Of Each Cmentioning

confidence: 89%

“…Of the prospective studies, three were pilot/feasibility studies performed in Europe and Oceania 26,28,32 and five were safety/efficacy trials performed in Europe, Oceania, and the United States. 14,25,27,[34][35][36] Of the retrospective studies, all were about the Advanta V12/iCast, three were performed in the United States, 29,33,37 two were in Europe, 30,31 and one was in Oceania. 38 The search identified nine published studies of the Advanta V12/iCast, two of the Viabahn VBX, one of the BeGraft, one of the LifeStream, and one of the JOSTENT.…”

Section: Resultsmentioning

confidence: 99%

“…[22][23][24] A total of 15 publications (14 studies) were ultimately included in this review and underwent data extraction (Table I). 14,[25][26][27][28][29][30][31][32][33][34][35][36][37][38] The complete dataset comprised patients treated in both the prospective trial and retrospective, real-world settings. Clinical trial setting conformed to strict inclusion and exclusion criteria of the protocol.…”

Section: Methodsmentioning

confidence: 99%

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A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease

Mwipatayi

Ouriel²,

Anwari

et al. 2020

Journal of Vascular Surgery

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Objective: To evaluate and compare studies reporting the outcomes of the use of covered balloon-expandable (CBE) stents for the treatment of aortoiliac occlusive disease. Methods: A systematic literature search was conducted to identify studies that investigated the use of CBE stents for the treatment of aortoiliac occlusive disease and were published between 2000 and 2019. Baseline demographic data, procedural variables, and long-term outcomes were extracted from publications for analysis. Results: A total of 15 published articles about 14 studies were included in the review. Of these, eight studies were prospective clinical trials and six studies were retrospective real-world studies. The articles included data regarding five different CBE stents, namely, the iCast/Advanta V12, Viabahn VBX, BeGraft, LifeStream, and JOSTENT. Lesion severity was higher in real-world studies, with more TransAtlantic Inter-Society Consensus Classification class D lesions and a higher percentage of occlusions. All studies showed high rates of technical success and patency over the course of 12 months. Long-term data were only available for the iCast/Advanta V12 device, which had a primary patency rate of 74.7% at 5 years. Conclusions: CBE stents are a viable treatment option for patients with complex aortoiliac lesions because of their high rates of technical success and favorable patency across all devices at 12 months. However, long-term data are only available for a single device, the iCast/Advanta V12. The results of using this device were favorable over the course of 5 years.

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Section: Comparison Of Devices a Comparison Of The Results Of Each Cmentioning

confidence: 89%

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease

Mwipatayi

Ouriel²,

Anwari

et al. 2020

Journal of Vascular Surgery

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“…The BeGraft Peripheral Stent Graft (Bentley InnoMed GmbH, Hechingen, Germany) is a balloonexpandable covered stent with a great amount of flexibility. 2 stents as bridging devices in an in vitro model simulating a fenestrated main body stent-graft.…”

Section: Introductionmentioning

confidence: 99%

“…The BeGraft Peripheral Stent Graft (Bentley InnoMed GmbH, Hechingen, Germany) is a balloon-expandable covered stent with a great amount of flexibility. 2 Recently, Bentley introduced a new-generation BeGraft+. The unique feature of this stent-graft is a double layer of graft material alternating with two stent rows.…”

Section: Introductionmentioning

confidence: 99%

Performance of BeGraft and BeGraft+ Stent-Grafts as Bridging Devices for Fenestrated Endovascular Aneurysm Repair: An In Vitro Study

et al. 2019

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Purpose: To investigate 2 generations of balloon-expandable covered stents as potential bridging devices using an in vitro model of stent-graft fenestrations. Materials and Methods: Twenty BeGraft and 20 BeGraft+ cobalt-chromium stents covered in expanded polytetrafluoroethylene (ePTFE) in 6- and 8-mm diameters were tested in sheets mimicking stent-graft fenestrations. Microscopy and radiography were employed to evaluate stent morphology after flaring. In vitro bench tests measured maximum pullout (perpendicular displacement) and the shear stress (axial displacement) forces needed to dislocate the stents. Results: No alteration of ePTFE coverage was detected in the flared stents. Digital radiography and computed tomography showed marked alteration of the stent geometry, which was more pronounced in the BeGraft group. No fractures were detected. Median (minimum–maximum) pullout forces for the 6-mm stent-grafts were 17.1 N (15.8–19.6) for the BeGraft device and 30.4 N (20.2–31.9) for the BeGraft+ device (p=0.006). Median (minimum–maximum) pullout forces for the 8-mm stent-grafts were 11.3 N (11–12.1) for the BeGraft device and 21.8 N (18.2–25.5) for the BeGraft+ device (p<0.001). The shear stress test showed median forces of 10.5 vs 15.28 N at 150% of the stent diameter for the 6-mm BeGraft and BeGraft+ stent-grafts, respectively, and 15.23 vs 20.72 N at 150% stent diameter for the 8-mm models (p=0.016 and 0.017, respectively). Conclusion: Flaring changed the stent geometry but did not provoke stent fractures. The BeGraft+ is superior to the BeGraft in terms of pullout and shear stress forces, demonstrating greater resilience.

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Midterm Results of the Treatment of Penetrating Abdominal Aortic or Iliac Artery Ulcer with the BeGraft Balloon-Expandable Covered Stent—A Single-Center Experience

Kruszyna

Dzieciuchowicz

Strauss

et al. 2020

Annals of Vascular Surgery

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BeGraft Peripheral PMCF Study: 12-month results

Cited by 6 publications

References 10 publications

A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease

A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease

Performance of BeGraft and BeGraft+ Stent-Grafts as Bridging Devices for Fenestrated Endovascular Aneurysm Repair: An In Vitro Study

Midterm Results of the Treatment of Penetrating Abdominal Aortic or Iliac Artery Ulcer with the BeGraft Balloon-Expandable Covered Stent—A Single-Center Experience

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