Evaluating a new stent system for treating iliac artery blockages.

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 study is testing a new stent to see if it can safely help people with blockages in their iliac arteries feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zhejiang Zylox Medical Device Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06605209 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with atherosclerotic disease affecting the iliac arteries and a Rutherford classification of 2 to 4.

Not a fit: Patients who are pregnant, have had recent strokes or heart attacks, or have severe bleeding disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from iliac artery stenosis or occlusion.

How similar studies have performed: Other studies have shown promise with similar stent systems, indicating potential for success in this approach.

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.

Where this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Wei Guo, MD

Conditions Peripheral Artery Disease; Covered Stent; iliac artery