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RECRUITING

NCT06605209

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

Sponsor: Zhejiang Zylox Medical Device Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Prospective, Multi-Center, Non-Randomized, Single-Arm Study Evaluating the Peripheral Balloon-Expandable Covered Stent System for the Treatment of Stenosis and/or Occlusive Lesions in the Common and External Iliac Arteries.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2024-11-08

Completion Date

2026-12-15

Last Updated

2024-12-04

Healthy Volunteers

Conditions

Peripheral Artery Disease (PAD)

Interventions

DEVICE

Peripheral Balloon-Expandable Covered Stent System

The intervention in this clinical trial involves the Peripheral Balloon-Expandable Covered Stent System. This stent system is specifically designed for the treatment of stenosis and/or occlusion in the common and external iliac arteries.

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.

Locations (1)

The First Medical Centre, Chinese PLA General Hospital

Beijing, Beijing Municipality, China