Iliac Artery Occlusion, Iliac Artery Stenosis
Conditions
Keywords
iliac artery occlusion, Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System, iliac artery stenosis
Brief summary
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.
Detailed description
Clinical follow-up visits should be conducted at before discharge, 30 days, 6 month, 9 months, and 12 months post-procedure. CTA and DUS will be performed at 6 month and 12 months post-procedure. The primary endpoints include primary patency rate of the target lesion at 12 months post-procedure and Major Adverse Events (MAE) at 9 months post-procedure.
Interventions
DEVICEBioresorbable Peripheral Balloon-Expandable Covered Scaffold System
Subjects in the arm will be treated with ICS-Elpis
Sponsors
Biotyx Medical (Shenzhen) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
General inclusion criteria 1. Patients with stenosis or occlusion of the common iliac artery and/or external iliac artery caused by atherosclerosis. 2. Age between 18 - 85 years old. Male or non-pregnant female. 3. Patients with intermittent claudication (Rutherford category 2-3) or ischemic rest pain (Rutherford category 4). 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. Angiographic Inclusion Criteria 1. Patients with evidence of unilateral or bilateral de novo or restenosis (non-stent treatment) lesion(s) in the common iliac artery and/or external iliac artery, with the stenosis degree of the target lesion being≥50% (including occlusion). 2. The target lesion(s) can be successfully crossed with a guide wire and pre-dilated with an appropriately sized balloon. 3. The target lesion(s) with reference vessel diameter between 4.0 mm and 12.0 mm, and total length of unilateral lesion(s) ≤ 100 mm (tandem lesions are allowed). 4. Up to two ipsilateral target lesions or bilateral lesions are allowed (one target lesion per limb, with the length adhering to the unilateral criterion). Up to two stents are allowed for stent overlap per side (i.e., a maximum of two stents can be implanted per side). 5. Patients with angiographic evidence of patent outflow vessels in the target limb, including: a healthy common femoral artery (\<50% stenosis); at least one of the deep femoral artery or superficial femoral artery is patent (\<50% stenosis); a healthy popliteal artery (\<50% stenosis); and at least one patent infrapopliteal vessel connected (\<50% stenosis). 6. For stenotic or occlusive target lesion(s) located at the ostium of the common iliac artery without a residual stump, intervention can be achieved through kissing stent technique.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint: Primary Patency Rate of the Target Lesion | At12 months | 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 | At 30 days (for death and MI) and 9 months (for TLR and major amputation) | 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. |
Countries
China
Contacts
Primary ContactYing Xia
Outcome results
None listed