Efficacy and Safety Evaluation of Biodegradable Peripheral Stent for Iliac Artery Lesions
- Conditions
- Peripheral artery disease for iliac artery lesions
- Registration Number
- JPRN-UMIN000042238
- Lead Sponsor
- KYOTO MEDICAL PLANNING Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 100
Not provided
1. Patient on dialysis or immunosuppressive therapy. 2. Patient with severe renal failure (serum creatinine > 2.0 mg/dL). 3. Patient who is allergic to drugs used for catheter treatment and examination (contrast agents, heparin, thienopyridine, aspirin, etc.). 4. Patient for whom antiplatelet and/or antithrombotic therapy is not available. 5. Patient on ongoing steroid hormone therapy. (ointments, creams due to skin diseases, eye drops, etc, and steroids during asthma attacks are allowed.) 6. Patient who requires debulking due to severe Calcification or other diseases. 7. Patient who has underwent stent implantation or surgical treatment within 10 mm distal / proximal from the target lesion. 8. Patient with in-stent restenosis. 9. Patient who developed myocardial infarction/cerebrovascular injury within 30 days before treatment. 10. Patient with acute or subacute obstruction at the target lesion. 11. Patient with hemorrhagic disease within the past 3 months. 12. Patient with aneurysms in abdominal aorta, iliac artery or other arteries. 13. (Possibly) pregnant women. 14. Patient who is not expected to live more than 12 months. 15. Patient who is enrolled in another clinical trial. In case that the patient has completed all the follow-ups in that study, he/she is eligible for this study. 16. Ineligible patient judged by PI (principal investigator) or other investigator .
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary patency rate at 12 months after stent implantation
- Secondary Outcome Measures
Name Time Method Efficacy Outcomes 1. Successful passage through the lesion of the device, its successful implantation in the intended target lesion, and the residual stenosis rate <30% (Acute procedural success). 2. Assisted primary patency rate and secondary patency rate 12 months after stent implantation. 3. WIQ (Walking Impairment Questionnaire) score. 4. Rutherford classification. Safety Outcomes 1. Adverse events 2. Failure of the clinical trial equipment 3. Procedural success rate at repeated operation