Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peripheral Balloon-Expandable Covered Stent System.
- Who it may be relevant to
- Registry conditions: Peripheral Artery Disease (PAD). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
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.
Primary outcome measures
- primary patency [Time frame: 12 months]
Secondary outcome measures (2)
- Major Adverse Event [Time frame: 36 months]
- Secondary Patency [Time frame: 6, 12, 24, and 36 Months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Medical Centre, Chinese PLA General Hospital — Beijing
Identifiers
NCT: NCT06605209 · ZRD-11