This trial is a prospective, single-center, first-in-man clinical trial to evaluate the feasibility, preliminary safety and effectiveness of the Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System. 15 subjects are intended to be enrolled.
Patients with stenosis or occlusion of the common iliac artery and/or external iliac artery caused by atherosclerosis.
Age between 18 - 85 years old. Male or non-pregnant female.
Patients with intermittent claudication (Rutherford category 2-3) or ischemic rest pain (Rutherford category 4).
Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to complete the follow-up according to the protocol requirements.
Patients with previously stented target lesion.
Patients who have undergone lower extremity arterial intervention within 30 days before the index procedure, or has such intervention planned for within 30 days after the index procedure.
Patients with a history of or planned ipsilateral aortoiliac bypass surgery during the index procedure.
Patients who were expected to undergo amputation of the target limb before the index procedure.
Single group
Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System
DeviceSubjects in the arm will be treated with ICS-Elpis
Primary Efficacy Endpoint: Primary Patency Rate of the Target Lesion
Primary patency is defined as the peak systolic velocity ratio (PSVR) ≤2.4 assessed by duplex ultrasonography (DUS) or the stenosis degree of the target lesion≤70% assessed by CTA; if there is a conflict between the results of DUS and CTA, the CTA result should prevail.
Primary Safety Endpoint: Rate of Major Adverse Events
The endpoint is a composite endpoint includes 1. Device or procedure-related death within 30 days 2. Myocardial Infarction (MI) within 30 days, 3. Target lesion revascularization (TLR) within 9 months, 4. Major amputation above the ankle joint of the target limb, resulting from a vascular event within 9 months.
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