Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System

NCT02211716 | Completed Phase 4 DMC

• 1 other identifier: FMRP-131216
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the BeGraft Peripheral Stent Graft System (Bentley InnoMed) in clincial settings post CE-certification when used according to the indications of the IFU.

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Primary patency at 12 months

  Defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (\>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months.

  12 months

Secondary Outcomes (10)

• Primary patency rate at 1- and 6-month follow-up

  1 and 6 months

• Stent graft occlusion rate at pre-discharge, 1-, 6- and 12-month follow-up

  1 day post-op, 1, 6 and 12 months

• Ankle Brachial Index (ABI) at 1-, 6- and 12-month follow-up

  1, 6 and 12 months

• Performance success rate at baseline

  1 day post-op

• In-stent restenosis rate at 1-, 6- and 12-month follow-up

  1, 6 and 12 months

Study Arms (1)

BeGraft

EXPERIMENTAL

Patient's treated with the BeGraft PMCF Stent Graft System from Bentley Innomed for the treatment of iliac lesions.

Device: BeGraft Peripheral Stent Graft System

Interventions

BeGraft Peripheral Stent Graft System DEVICE

BeGraft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.
• Patient presenting with a stenotic or occlusive lesion at the iliac arteries suitable for stenting (on indication for primary stenting, based on the discretion of the investigator)
• Patient presenting a score from 2 to 5 following Rutherford classification
• Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
• Patient is \>18 years old
• Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
• Patient is eligible for treatment with the BeGraft Peripheral Stent Graft System (Bentley InnoMed)
• The target lesion is either a modified TASC-II class A, B, C or D lesion with one of the listed specifications:
• Type A lesions
• Unilateral or bilateral stenoses of the Common Iliac Artery
• Unilateral or bilateral single short (≤3 cm) stenosis of the External Iliac Artery
• Type B lesions
• Unilateral Common Iliac Artery occlusion
• Single or multiple stenosis totaling 3-10 cm involving the External Iliac Artery not extending into the Common Femoral Artery
• Unilateral External Iliac Artery occlusion not involving the origins of Internal Iliac Artery or Common Iliac Artery

You may not qualify if:

• PTA is technically not possible (not feasible to access the lesion or a defect with the guidewire or balloon catheter)
• Presence of an aneurysm immediately adjacent to the site of stent implantation
• Stenosis distal to the site of stent implantation
• Lesions in or adjacent to essential collateral(s)
• Lesions in locations subject to external compression
• Heavily calcified lesions resistant to PTA
• Patients with diffuse distal disease resulting in poor stent outflow
• Patients with a history of coagulation disorders
• Patients with aspirin allergy or bleeding complications and patients unable or unwilling to tolerate anticoagulant/antiplatelet therapy and/or non-responders to anticoagulant/antiplatelet therapy
• Fresh thrombus formation
• Patients with known hypersensitivity to the stent material (L605) and/or PTFE
• The target lesion is either a modified TASC-II class B or D lesion with aortic or common femoral lesion involvement:
• Type B lesions
• Short (≤3 cm) stenosis of infrarenal aorta
• Type C lesions

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (4)

OLV Hospital

Aalst, 9300, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius

Dendermonde, 9200, Belgium

Location

RZ Heilig Hart Tienen

Tienen, 3300, Belgium

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Koen Deloose, MD

  Flanders Medical Research Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 7, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 12, 2017

Record last verified: 2016-02

Locations

BE (4)