A Prospective, Single-Center, First-in-Man Clinical Trial to Evaluate the Safety and Feasibility of the Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System in Patients With Iliac Artery Stenosis or Occlusion Lesions
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Biotyx Medical (Shenzhen) Co., Ltd.
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Primary Efficacy Endpoint: Primary Patency Rate of the Target Lesion
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General inclusion criteria
- •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.
- •Angiographic Inclusion Criteria
- •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).
- •The target lesion(s) can be successfully crossed with a guide wire and pre-dilated with an appropriately sized balloon.
- •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).
- •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).
排除标准
- •General exclusion criteria
- •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.
- •Patients with an aneurysm, perforation and/or dissection of the target iliac artery before the index procedure.
- •Patients who have undergone coronary artery intervention within 30 days before the index procedure, or has such intervention planned for within 30 days after the index procedure (including the index procedure).
- •Patients with acute myocardial infarction or angina pectoris within 30 days before the index procedure.
- •Patients with a stroke within 3 months before the index procedure, or a stroke more than 3 months before the index procedure accompanied by severe paralysis and aphasia sequelae.
- •Patients with known intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
结局指标
主要结局
Primary Efficacy Endpoint: Primary Patency Rate of the Target Lesion
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点