Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
NCT ID: NCT06605209
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2024-11-08
2026-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Peripheral Balloon-Expandable Covered Stent System Group
This arm of the study involves the use of the Peripheral Balloon-Expandable Covered Stent System. 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Zhejiang Zylox Medical Device Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Medical Centre, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZRD-11
Identifier Type: -
Identifier Source: org_study_id