Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture
Conditions
Brief summary
The objective of this clinical investigation is to evaluate, in a controlled setting, the safety and performance of the BGP+ balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent in BEVAR (branched endovascular aortic repair) for complex aortic aneurysms.
Interventions
DEVICEBGP+ Stent Graft System as bridging stent
BGP+ Stent Graft System as bridging stent
Sponsors
Bentley InnoMed GmbH
Marc Bosiers, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Application of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient eligible for elective repair of TAAA with BEVAR in accordance with the applicable guidelines for vascular interventions (e.g. Aneurysm size 6cm or aneurysm growth of \>5mm within 6 months or 1cm within 1 year) 2. Patient is willing to comply with specified follow-up evaluations at the specified times 3. Patient is \>55 years old 4. Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the trial • Patient has a projected life-expectancy of at least 12-months 5. Patient needs to have a landing zone in their target vessel of at least 15 mm, and coverage/ wall adaptation of the BGP+ should be obtained for at least 10 mm. 6. The access vessel for introduction of the sheath through which the BGP+ will be advanced should be at least 3mm (it should be able to fit a 8F sheath) 7. No early important division branch from the target vessel with risk of coverage 8. Absence of pre-existing dissection in the target vessels 9. Target vessels (renal arteries, superior mesenteric artery, and celiac trunk) for the BGP+ must have a diameter between 5 and 10 mm 10. Aortic endoprosthesis with inner branches (can be hybrid or branches only) 11. Hybrid aortic endoprosthesis with fenestrations and branches (at least 2 and only the target vessels which are connected by a branch shall be treated with a study device within this study) 12. At least one target vessel is bridged with only one BGP+ (relining allowed) 13. Full compliance with all inclusion criteria/
Exclusion criteria
and all intraoperative criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy endpoint (1) - Technical success | 1 day post-op | defined as successfully introduction and deployment of the BGP+ balloon expandable covered Stent Graft System implanted as bridging stent in BEVAR |
| Efficacy endpoint (2) - Bridging stent patency at 12 months | 12 months post-op | defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on CT angio at 12 months |
| Safety endpoint - Absence of procedure related complications and bridging stent related endoleaks at 12 months | 12 months post-op | Absence of procedure related complications and bridging stent related endoleaks at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from type I & III endoleaks post-procedure post-procedure | 1 day post-op, 6-, 12-, and 24- months post-op | Freedom from type I & III endoleaks post-op and at 6-, 12- and 24- months, based on imaging (duplex ultrasound, CT angiography) |
| 30-day mortality | 30 days post-op | — |
| Freedom from stent graft migration | 1 day post-op, 6-, 12 -and 24- months post-op | defined as freedom from stent graft migration (more than 10 mm) |
| Freedom from AAA diameter increase | 6-, 12- and 24- months post-op | defined as more than 5mm increase in maximum diameter measured at 6-, 12- and 24- months as compared to post-op implantation, based on imaging (duplex ultrasound or CT Angiography) |
| Freedom from aneurysm related secondary endovascular procedures | 1 day post-op, at 6-, 12- and 24- months post-op | Freedom from aneurysm related secondary endovascular procedures post-op |
| Bridging stent patency post-procedure | 1 day post-op, 6- and 24- months post-op | defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on Duplex Ultrasound or CT Angio |
| Freedom from aneurysm related mortality post-procedure | 1 day post-op, 6-, 12-, 24- months post-op | — |
| Freedom from aneurysm rupture post-implantation | up to 12- and 24- months post-op | Freedom from aneurysm rupture within 12- and 24-months post-implantation |
| Freedom from any major adverse events post-procedural and at 6 and 12 months | 1 day post-op, 6-, 12- and 24- months post-op | — |
| Health Related Quality of Life scores | 12- and 24- months post-op | Health Related Quality of Life scores at 12- and 24 months post implantation |
| Freedom from conversion to open surgical repair post-procedure | 1 day post-op, 6-, 12-, 24- months post-op | Freedom from conversion to open surgical repair post-op and at 6, 12 and 24 months |
| Freedom from bridging stent related endoleaks post-procedure | 1 day post-op, 6- and 24- months post-op | Freedom from bridging stent related endoleaks post-op, at 6- and 24- months, based on imaging (duplex ultrasound, CT angiography) |
| Freedom from bridging stent related secondary intervention | 1 day post-op, 6-, 12- and 24- months post-op | Freedom from bridging stent related secondary intervention |
Countries
Germany
Outcome results
None listed