Status:
RECRUITING
Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
Lead Sponsor:
Zhejiang Zylox Medical Device Co., Ltd.
Conditions:
Peripheral Artery Disease (PAD)
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ilia...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06605209
Start Date
November 8 2024
End Date
December 15 2026
Last Update
December 4 2024
Active Locations (1)
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1
The First Medical Centre, Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100000