Occlusive/Stenotic Peripheral artery REvascularization study
- Conditions
- Peripheral arterial disease of lower extremities by a stenotic or occlusive de novo lesion at SFA/PA
- Registration Number
- JPRN-UMIN000003291
- Lead Sponsor
- Terumo Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
(1) Terminal illness in whom life expectancy is expected to be less than 3 years. (2) Patients who are participating in other clinical study of medical device or pharmaceuticals within 3months before registration. (3) Already participated in this study in the past. (4) Previously received a bypass surgery, stent implantation or any surgery at SFA or distally. (5) Scheduled for a staged procedure to treat lesions within the aorta or ipsilateral run-off vessels after enrollment. (6) Allergy or experienced an anaphylactic symptom to components of the study device. (7) Acute or chronic renal failure (serum creatinine 2.0mg/dL or more) (8) Advanced calcification or excessive tortuosity at target lesion (9) Patients who are pregnant or breast-feeding, or in whom these conditions are possible. (10) Patients who were judged to be inappropriate for participation in the study due to severe or uncontrolled systemic disease of any condition by the principal investigators/investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method