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:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
NCT ID:
NCT04299906
Eligibility Criteria:
Inclusion Criteria:
* Corresponding to the IFU 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
* The target lesion is either a modified TASC-II class A, B, C or D lesion.
* 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
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 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.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04299906
Study Brief:
Protocol Section:
NCT04299906