Evaluating a new stent system for treating iliac artery blockages.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the Peripheral Balloon-Expandable Covered Stent System in patients with stenosis or occlusion in the common and external iliac arteries. It is a prospective, multi-center, single-arm trial where participants will receive the stent and be monitored for outcomes at various follow-up intervals. The performance of the stent system will be compared against established performance goals to determine its efficacy in treating peripheral artery disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Medical Centre, Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Wei Guo, MD
• Email: pla301dml@vip.sina.com
• Phone: +86 010-66938349

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.