Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)

Not Applicable

Recruiting

• Conditions: Peripheral Artery Disease (PAD)
• Interventions: Device: Peripheral Balloon-Expandable Covered Stent System

• Registration Number: NCT06605209
• Lead Sponsor: Zhejiang Zylox Medical Device Co., Ltd.

Brief Summary

This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and/or occlusion in the common and external iliac arteries. The safety and effectiveness of the stent system will be compared to pre-set performance goals. All treated subjects will have follow-up visits at discharge, and at 1, 6, 12, 24, and 36 months after the procedure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-20
• Status Verified: 2024-11
• Study Start: 2024-11-08
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-07-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Participants aged 18 to 80 years, regardless of sex;
• Participants diagnosed with atherosclerotic disease of the common iliac or external iliac artery;
• Participants with a Rutherford classification of 2 to 4 for the target limb;
• Participants or their legal representatives must be able to understand the study's purpose, demonstrate adequate compliance with the study protocol, and sign the informed consent form.

Exclusion Criteria

• Pregnant or planning to become pregnant, or breastfeeding women;
• Participants who have previously had a vascular graft implanted in the native iliac artery;
• Participants who have had a stroke or myocardial infarction within 3 months prior to enrollment;
• Participants with known uncorrectable bleeding disorders or severe coagulation abnormalities (PT or APTT ≥ 2 times the upper limit of normal; or platelet count < 80×10^9/L);
• Participants with serum creatinine ≥ 221 μmol/L (2.5 mg/dL) or currently undergoing dialysis;
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal;
• Severe anemia (hemoglobin level < 60.0 g/L);
• Participants known to be allergic or intolerant to cobalt-based alloys, expanded polytetrafluoroethylene (ePTFE), aspirin, clopidogrel, heparin, rivaroxaban, paclitaxel, contrast agents, or other study materials and medications;
• Participants who have undergone vascular intervention within 30 days prior to surgery or who plan to undergo vascular intervention within 30 days following surgery;
• Participants who have received intra-arterial thrombolysis treatment in the target vessel within 14 days prior to enrollment;
• Participants with significant organ dysfunction or other severe conditions that may lead to non-compliance with the study protocol, affect data interpretation, or have a life expectancy insufficient to complete the clinical trial;
• Participants currently involved in a clinical trial of investigational drugs, biologics, or medical devices;
• Other conditions that, in the investigator's opinion, make the participant unsuitable for the clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peripheral Balloon-Expandable Covered Stent System Group	Peripheral Balloon-Expandable Covered Stent System	This arm of the study involves the use of the Peripheral Balloon-Expandable Covered Stent System developed by Zhejiang Cryofocus Medtech Co., Ltd. The intervention consists of implanting this stent system into the common and/or external iliac arteries of participants who have been diagnosed with stenosis and/or occlusion. The stent system is designed to be balloon-expandable and covered, providing a means to treat arterial blockages. Participants in this arm will undergo the stent implantation procedure, followed by scheduled follow-up visits at discharge, and at 1, 6, 12, 24, and 36 months post-procedure. During these visits, the safety and effectiveness of the stent system will be assessed based on predefined performance goals, including clinical outcomes and any adverse events related to the stent.

Primary Outcome Measures

Name	Time	Method
primary patency	12 months	Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory

Secondary Outcome Measures

Name	Time	Method
Major Adverse Event	36 months	Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death, myocardial infarction (MI), target lesion revascularization (TLR) or major amputation of the target limb.
Secondary Patency	6, 12, 24, and 36 Months	The secondary patency of target lesion at 6, 12, 24, and 36 Months assessed by duplex ultrasound and adjudicated by an independent core laboratory

Trial Locations

Locations (1)

The First Medical Centre, Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China