Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06605209, who can take part
Where in China
- The First Medical Centre, Chinese PLA General HospitalBeijing, ChinaContact: Wei Guo, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Zhejiang Zylox Medical Device Co., Ltd.
- Trial code
- NCT06605209
- Record updated
- 4 December 2024
- Original description
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.Read full original descriptionShow less
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.
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.
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: 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 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 currently involved in a clinical trial of investigational drugs, biologics, or medical devices; 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 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; Other conditions that, in the investigator's opinion, make the participant unsuitable for the clinical trial; 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); Pregnant or planning to become pregnant, or breastfeeding women.