Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02211716
• Date of registration: 06/08/2014
• Prospective Registration: No
• Primary sponsor: Flanders Medical Research Program
• Public title: Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System
• Scientific title: Physician-Initiated PMCF Trial Investigating the BeGraft Peripheral Stent Graft System for the Treatment of Iliac Lesions
• Date of first enrolment: June 2014
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02211716
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Belgium

Contacts

• Name: Koen Deloose, MD
• Affiliation: Flanders Medical Research Program

Key inclusion & exclusion criteria

Inclusion Criteria

1. General Inclusion criteria

- 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)

2. Angiographic Inclusion Criteria

- 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

- Type C lesions

- Bilateral Common Iliac Artery occlusions

- Bilateral External Iliac Artery stenoses 3-10 cm long not extending
into the Common Femoral Artery

- Type D lesions

- Unilateral occlusions of both Common Iliac and External Iliac Artery

- Diffuse disease involving the aorta and both iliac arteries requiring
treatment

- Bilateral occlusions of External Iliac Artery

- The target lesion has angiographic evidence of stenosis or restenosis > 50% or
occlusion which can be passed with standard guidewire manipulation

- There is angiographic evidence of a patent Common an Deep Femoral Artery

Exclusion Criteria

- 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

- Unilateral External Iliac Artery stenosis extending into the Common Femoral
Artery

- Unilateral External Iliac Artery occlusion that involves the origins of the
Internal Iliac and/or Common Femoral Artery

- Heavily calcified unilateral External Iliac Artery occlusion with or without
involvement of origins of the Internal Iliac and/or Common Femoral Artery

- Type D lesions

- Infra-renal aortoiliac occlusion

- Iliac stenoses in patients with an Abdominal Aortic Aneurysm (AAA) requiring
treatment and not amenable to endograft placement or other lesions requiring
open aortic or iliac surgery

- Diffuse multiple stenoses involving the unilateral Common Iliac, External
Iliac and Common Femoral Artery

- Previously implanted stent(s) at the same lesion site

- Reference segment diameter is not suitable for the available stent design

- Untreatable lesion located at the distal outflow arteries

- Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation
therapy) as part of the index procedure

- Patients refusing treatment

- Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are
contraindicated

- Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion
site

- Perforation at the angioplasty site evidenced by extravasation of contrast medium

- Patients with a history of prior life-threatening contrast medium reaction

- Patients with uncorrected bleeding disorders

- Female patient with child bearing potential not taking adequate contraceptives or
currently breastfeeding

- Life expectancy of less than twelve months

- Any planned surgical intervention/procedure within 30 days of the study procedure

- Any patient considered to be hemodynamically unstable at onset of procedure

- Patient is currently participating in another investigational drug or device study
that has not completed the entire follow up period



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Vascular Disease

Intervention(s)

Device: BeGraft Peripheral Stent Graft System

Primary Outcome(s)

Primary patency at 12 months [Time Frame: 12 months]

Secondary Outcome(s)

Performance success rate at baseline [Time Frame: 1 day post-op]

Primary patency rate at 1- and 6-month follow-up [Time Frame: 1 and 6 months]

Amputation rate at 1-, 6- and 12-month follow-up [Time Frame: 1, 6 and 12 months]

In-stent restenosis rate at 1-, 6- and 12-month follow-up [Time Frame: 1, 6 and 12 months]

Ankle Brachial Index (ABI) at 1-, 6- and 12-month follow-up [Time Frame: 1, 6 and 12 months]

Serious Adverse Avents [Time Frame: up to 12 months]

Clinical success at 1-, 6- and 12-month follow-up [Time Frame: 1, 6 and 12 months]

Stent graft occlusion rate at pre-discharge, 1-, 6- and 12-month follow-up [Time Frame: 1 day post-op, 1, 6 and 12 months]

Technical success [Time Frame: 1 day post-op]

Freedom from Target Lesion Revascularization (TLR) at 1-, 6- and 12-months [Time Frame: 1, 6 and 12 months]

Secondary ID(s)

FMRP-131216

Source(s) of Monetary Support

Please refer to primary and secondary sponsors