RECRUITINGINTERVENTIONAL
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.
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form form.
Who Should NOT Join This Trial:
- 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;
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
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.
Locations (1)
The First Medical Centre, Chinese PLA General Hospital
Beijing, Beijing Municipality, China