BeFlared Versus VBX for FEVAR

Medical University of Vienna126 enrolled

Overview

This randomized controlled unblinded trial aimes to compare BeFlared FEVAR Stent Graft System (BeFlared) with GORE® VIABAHN® VBX Balloon Expandable Endoprothesis (VBX) in patients undergoing endovascular aneurysm repair with fenestrated device (FEVAR). Primary objectives: * compare cumulative device time between patients undergoing FEVAR with BeFlared and VBX brindging device; * compare target vessel (TV) instability at early, short-term and midterm follow-up in patients undergoing FEVAR with BeFlared and VBX brindging device. Secondary objectives: \- compare intraoperative TV technical success in patients undergoing FEVAR with BeFlared and VBX bridging device.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

126

Conditions

Fenestrated Endovascular Aortic Repair

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * written informed consent form signed by the patients before admission to the study; * age \> 18 years; * power of judgement and understanding capability of person; * patients with juxtarenal, pararenal, paravisceral AAA, EL Type IA with a previous history of EVAR procedure or TAAA (extent I-IV in accordance with Crawford Classification) undergoing emergency/elective treatment with FEVAR (custom-made or off-the-shelf endograft) at the Division of Vascular Surgery, Department of General Surgery, Medical University of Vienna. Exclusion Criteria: * age \< 18 years; * all female patients with a pregnancy possibility (premenopausal)

Outcomes

Primary Outcomes

Cumulative device time

Cumulative device time (measured in minutes) is defined as time between introduction of bridging stent graft (BSG) system into sheath and successful removal of deflated BSG flaring balloon for each of target vessels.

Time frame: Intraoperative assessment during recruitment period of 2 years

Target vessel (TV) instability at follow-up

TV instability at early, short-term and midterm follow up - defined as any death or aneurysm rupture event related to TV complication (e.g. TV endoleak or rupture) or any secondary intervention indicated to treat a TV related complication, including TV endoleak, disconnection, kinking, stenosis, occlusion, or rupture. Early follow-up is defined as radiological and clinical follow-up of the patients within the first 30 postoperative days or withing the hospital stay if longer than 30 days. Short-term follow-up encompass follow-up between 30 days and 6 months. Midterm follow-up refer to follow-up that occur within 6 months to 5 years after FEVAR procedure.

Time frame: Early follow-up of first patients enrolled - end of midterm follow-up of last patients enrolled

Secondary Outcomes

Intraoperative target vessel (TV) success

Intraoperative target vessel (TV) technical success is defined as successful TV catheterization and placement of bridging stent graft (BSG) with restoration and maintenance of flow in all intended TVs.

Time frame: Intraoperative assessment during recruitment period of 2 years

Central Contacts

Wolf Hans Eilenberg, MD, PhD

CONTACT

+43 (0)1 40400-69560 wolf.eilenberg@meduniwien.ac.at

Anna Sotir, MD