BGP+ Stent as Bridging Stent in BEVAR (NCT03982940) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
BGP+ Stent as Bridging Stent in BEVAR
Germany118 participantsStarted 2020-09-09
Plain-language 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.
Who can participate
Age range55 Years
SexALL
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Inclusion criteria
✓. 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)
✓. 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 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 pre-existing dissection in the target vessels
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
What they're measuring
1
Efficacy endpoint (1) - Technical success
Timeframe: 1 day post-op
2
Efficacy endpoint (2) - Bridging stent patency at 12 months
Timeframe: 12 months post-op
3
Safety endpoint - Absence of procedure related complications and bridging stent related endoleaks at 12 months