Status:
COMPLETED
Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System
Lead Sponsor:
Flanders Medical Research Program
Conditions:
Peripheral Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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)...
Detailed Description
Endovascular techniques are well accepted in the treatment of iliac occlusive disease. It is shown that in the iliac artery especially stenoses and short occlusions respond well to percutaneous transl...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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)
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02211716
Start Date
June 1 2014
End Date
April 1 2016
Last Update
January 12 2017
Active Locations (4)
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1
OLV Hospital
Aalst, Belgium, 9300
2
Imelda Hospital
Bonheiden, Belgium, 2820
3
AZ Sint-Blasius
Dendermonde, Belgium, 9200
4
RZ Heilig Hart Tienen
Tienen, Belgium, 3300