Bentley Bridging Stent Graft Study
ConditionAortic Aneurysm
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBentley InnoMed GmbH
About this trial
This international, observational multi-centre observational study of the devices BeFlared FEVAR Stent Graft System (BeFlared), BeGraft Stent Graft System (BeGraft), and BeGraft Plus Stent Graft System (BeGraft Plus) will monitor technical success of the implantation, data regarding clinical performance, clinical benefit, as well as potential unknown side effects for the use as bridging stent grafts in combination with fenestrated aortic endovascular grafts.
Eligibility criteria
Qualifiers
Adult patients having complex abdominal aortic aneurysms suitable for an endovascular repair with a fenestrated and/or branched aortic endovascular graft in combination with one Bentley bridging stent graft per reno-visceral artery in accordance with the IFU of BeFlared, BeGraft or BeGraft Plus. Use of different products for different target vessels is allowed. Use of stents from other manufacturers for other reno-visceral arteries is allowed.
Patient is capable and willing to sign the informed consent and agrees to fulfil follow-up requirements
Patients ≥18 years of age at the time of consent
Disqualifiers
Patients with contraindications as listed in the IFUs
Previous stenting of the target vessel
Extension/relining of Bentley BSGs
Prior EVAR procedure
Trial design
Treatments tested in this trial
- endovascular aortic repair (EVAR)
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Bentley InnoMed GmbH
Lead sponsor
NAMSA
Collaborator
Source ClinicalTrials.gov