BGP+ Stent as Bridging Stent in BEVAR
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BGP+ Stent Graft System Application of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms |
Device: BGP+ Stent Graft System as bridging stent
BGP+ Stent Graft System as bridging stent
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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
- 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
- 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 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient eligible for elective repair of TAAA with BEVAR in accordance with the applicable guidelines for vascular interventions (Aneurysm size 6cm or aneurysm growth of >5mm within 6 months or 1cm within 1 year)
-
Patient is willing to comply with specified follow-up evaluations at the specified times
-
Patient is >55 years old
-
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
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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.
-
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)
-
No early important division branch from the target vessel with risk of coverage
-
Absence of dissection
-
Target vessels (renal arteries, superior mesenteric artery and celiac trunk) should have a diameter between 5 and 10 mm
Exclusion Criteria:
-
Previously implanted stent in the target vessel
-
Renal artery with >100° cranial orientation
-
Patients refusing treatment
-
Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
-
Patients with uncorrected bleeding disorders or heparin induced thrombocytopenia
-
Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
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Any planned surgical intervention/procedure within 30 days of the trial procedure
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Patients with rupture or any patient considered to be hemodynamically unstable at onset of procedure
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Patient is currently participating in another investigational drug or device trial that has not completed the entire follow up period.
-
Patients with diffuse distal disease resulting in poor stent outflow
-
Fresh thrombus formation
-
Patients with known hypersensitivity to the stent material (L605) and/or PTFE
-
Hybrid Approach
-
Patients with a connective tissue disorder
-
Patients with mycotic or inflammatory aneurysm
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Myocardial infarction or stroke within 3 months prior to the procedure
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Patients with an unstable angina pectoris or heart insufficiency NYHA 3 or 4
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Patients with ASA classification 5 or higher
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Contraindications against contrast enhanced angiography (a.e. massive hyperthyroidism)
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Patients with increased risk of intraoperative rupture
-
Patients with access vessel which are too tortuous, narrow or any kind of reason that would lead to failure of introducing and advancing an introducer sheath
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Aachen | Aachen | Germany | ||
| 2 | University Hospital Eppendorf, UKE Hamburg | Hamburg | Germany | ||
| 3 | University Hospital Leipzig | Leipzig | Germany | ||
| 4 | University Hospital LMU Munich | Munich | Germany | ||
| 5 | St. Franziskus Hospital | Münster | Germany | 48145 | |
| 6 | Klinikum Nürnberg Süd | Nürnberg | Germany | ||
| 7 | University Hospital Regensburg | Regensburg | Germany | ||
| 8 | Hospital Stuttgart | Stuttgart | Germany |
Sponsors and Collaborators
- Prof. Giovanni Torsello
Investigators
- Study Director: Giovanni Torsello, Prof. Dr., Foundation for Cardiovascular Research and Education
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FCRE-190129