Peripheral artery disease for iliac artery lesions
Conditions
Interventions
Biodegradable peripheral stent
Sponsors
KYOTO MEDICAL PLANNING Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is 20 years old or older, regardless of gender. 2. Written consent is obtained from the patient (in cases that it is difficult to obtain consent from the person who is to be the subject, consent from the person who is to be the alternate must be obtained). 3. Patient with intermittent claudication or resting pain that limits their daily activities. 4. Patient who is eligible for 60 months follow-up and is able to comply with the follow-up requirements. 5. Patient with lesions in the common or external iliac artery. 6. Patient with significant de novo stenotic lesions with stenosis rate >= 70% or with suboptimal percutaneous transluminal angioplasty (PTA) (residual stenosis > 50%, recoil, dissection, intimal flap, etc.) 7. Patient with A or B lesion in TASC II classification (one lesion per limb per patient is registered). (In case of bilateral lesions, the second lesion should be treated 30 days after the first implantation.). The same day intervention is allowed if the ipsilateral SFA (superficial femoral artery area) is involved. 8. Patient with resting ABI or post-exercise. ABI of 0.9 or less. 9. Patient with a target lesion stenosis length of 70 mm or less measured by angiography using a radiopaque ruler or IVUS (Intravascular Ultrasound). 10. Target vessel reference diameters is >= 5.0 mm and <= 9.0 mm.
Exclusion criteria
Exclusion criteria: 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 .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rate at 12 months after stent implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactChisa Matsubara
KYOTO MEDICAL PLANNING Co., Ltd. R & D Division
Outcome results
None listed