Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:01 PM
Ignite Modification Date:
2025-12-24 @ 1:01 PM
NCT ID:
NCT03286361
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03286361
Study Brief:
Protocol Section:
NCT03286361