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.
Zhejiang Zylox Medical Device Co., Ltd.
130 participants
Nov 8, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria13
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06605209