NCT06605209 Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
| NCT ID | NCT06605209 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhejiang Zylox Medical Device Co., Ltd. |
| Condition | Peripheral Artery Disease (PAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2026-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2024-11-08 with a primary completion date of 2026-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06605209 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Peripheral Artery Disease (PAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06605209 currently recruiting?
Yes, NCT06605209 is actively recruiting participants. Contact the research team at pla301dml@vip.sina.com for enrollment information.
Where is the NCT06605209 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06605209 clinical trial?
NCT06605209 is sponsored by Zhejiang Zylox Medical Device Co., Ltd.. The trial plans to enroll 130 participants.