Bentley Bridging Stent Graft Study

N/ANot Yet RecruitingNCT07295145

Bentley InnoMed GmbH150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Aortic Aneurysm

Interventions

endovascular aortic repair (EVAR)DEVICE

The primary goal of EVAR is to bypass the aneurysm sac with the aortic endovascular graft. Through isolation of the aneurysm sac, the blood pressure on the affected aortic tissue is reduced. This prevents aneurysm growth, which is otherwise associated with an elevated risk of rupture. As the pressure on the aneurysm sac is minimized, the current risk of rupture is also mitigated. In case that arteries branch off from the aorta in the area of the aneurysm, or at the proximal and distal sealing zones of the endograft, complex EVAR approaches are employed, which include stenting of the aortic branches (mostly renal and visceral arteries, also called target vessels) in addition to implantation of an aortic endovascular graft. A distinction is made between different variants of complex EVAR procedures, which comprise fenestrated endovascular aneurysm repair (FEVAR), branched endovascular aneurysm repair (BEVAR) and hybrid approaches.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Patients with contraindications as listed in the IFUs * Previous stenting of the target vessel * Extension/relining of Bentley BSGs * Prior EVAR procedure

Outcomes

Primary Outcomes

Target vessel instability at 12 months, defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention

Time frame: 12 months post index procedure

Secondary Outcomes

Target vessel instability defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention

Time frame: 1 month, 24 months, 36 months, 48 months, and 60 months post index procedure

Procedure-related complications

Time frame: during procedure, at discharge and 1 month and 12 months post index procedure

Bridging stent-related complications

Time frame: during procedure, and 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure

technical success defined as correct positioning and deployment of bridging stent grafts

Time frame: during procedure

Primary patency rate defined as uninterrupted patency with no occlusion

Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure

Secondary patency rate

Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure

Freedom from secondary procedures

Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure

Freedom from bridging stent related endoleaks

Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure

Central Contacts

Richard A Griesbach, Dr

CONTACT

+49 7471 9999 117 r.griesbach@bentley.global

Data from ClinicalTrials.gov

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