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Peripheral Vascular Disease

Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System

Sponsored by Flanders Medical Research Program

About this trial

Last updated 9 years ago

Study ID

FMRP-131216

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 9 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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
No

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