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

RECRUITINGNA

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

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.

NCT06605209•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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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;
+3 more criteria

Locations (1)

The First Medical Centre, Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

November 8, 2024

Primary Completion Date

July 15, 2026

Completion Date

December 15, 2026

Last Updated

December 4, 2024

Enrollment

130

ESTIMATED participants

Conditions

Peripheral Artery Disease (PAD)

Interventions

Peripheral Balloon-Expandable Covered Stent System

DEVICE

Contacts

Wei Guo, MD

CONTACT

+86 010-66938349 pla301dml@vip.sina.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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