Clinical Trial Investigating the BeGraft Peripheral Plus Stent Graft System for Iliac Lesion Treatment (BeGraft+PMCF)
Peripheral Arterial Disease
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
General inclusion criteria
- Corresponding to the Conformité Européenne (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 Plus Stent Graft System (Bentley)
- Patient is treated as emergency case (ruptures, perforations, aneurysms and fistulae)
Angiographic inclusion criteria:
- 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 and Deep Femoral Artery
The target lesion is either a modified TASC-II class A, B, C or D lesion with one of the listed specifications:
o Type A lesions
- Unilateral or bilateral stenosis of the Common Iliac Artery
Unilateral or bilateral single short (≤3 cm) stenosis of the External Iliac Artery
o 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
o Type C lesions
- Bilateral Common Iliac Artery occlusions
Bilateral External Iliac Artery stenoses 3-10 cm long not extending into the Common Femoral Artery
o Type D lesions
- Unilateral occlusions of both Common Iliac and External Iliac Artery
- Diffuse disease involving the aorta bifurcation
- Bilateral occlusions of External Iliac 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 collaterals(s)
- Lesions in locations subject to external compression
- Heavily calcified lesions resistant to percutaneous transluminal angioplasty (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 polytetrafluoroethylene (PTFE)
- 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, drug-coated balloon (DCB), 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
- 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.
The target lesion is either a modified TASC-II class B, C or D lesion with aortic or common femoral lesion involvement:
o Type B lesions
Short (≤3 cm) stenosis of infrarenal aorta
o 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
o 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
Sites / Locations
- O.L.V. Hospital
- ZNA
- Imelda Hospital
- A.Z. Sint-Blasius
- ZOL
- az Groeninge
- RZ Heilig Hart
- AZ Jan Portaels
- CHU de Nantes
Arms of the Study
Arm 1
Experimental
BeGraft Peripheral + Stent Graft System
Patients treated with the BeGraft Peripheral Plus Stent Graft System