Peripheral Artery Disease (PAD)
Conditions
Keywords
Covered Stent, iliac artery
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.
Interventions
DEVICEPeripheral 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.
Sponsors
Zhejiang Zylox Medical Device Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| primary patency | 12 months | Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Event | 36 months | Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death, myocardial infarction (MI), target lesion revascularization (TLR) or major amputation of the target limb. |
| Secondary Patency | 6, 12, 24, and 36 Months | The secondary patency of target lesion at 6, 12, 24, and 36 Months assessed by duplex ultrasound and adjudicated by an independent core laboratory |
Countries
China
Contacts
Primary ContactWei Guo, MD
Outcome results
None listed