Occlusive/Stenotic Peripheral artery REvascularization studY for LONG stent
- Conditions
- Peripheral arterial disease of lower extremities by a stenotic or occlusive de novo lesion at SFA/PA
- Registration Number
- JPRN-UMIN000006636
- Lead Sponsor
- Terumo Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
(1) Patients with terminal illness in whom life expectancy is expected to be less than 1 years (2) Patients who are participating in other clinical study of medical device or pharmaceuticals within 3months before registration (3) Patients who already participated in this study in the past. (4) Patients who 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) Patients who have allergy or experienced an anaphylactic symptom to components (Nitinol, gold etc.) of the study device (7) Patients with acute or chronic renal dysfunction (serum creatinine value is 2.0 mg/dL or greater) (8) Patients with advanced calcification or excessive tortuosity at target lesion detected by DUS/angiography (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 on-TLF rate within 30 days
- Secondary Outcome Measures
Name Time Method Delivery success, Lesion success, Patency rate, Acute Gain, ABI, Rutherford classification, QoL, Adverse events, Serious adverse events, Major adverse events, Device failures/Malfunctions including stent fracture, Complications relate to investigational devices