Peripheral arterial disease of lower extremities by a stenotic or occlusive de novo lesion at SFA/PA
Conditions
Interventions
Stent
Sponsors
Terumo Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)20 years of age and older, (on the signature date of the consent form) (2) Informed consent (3) Rutherford classification (category 2, 3 or 4) (4) Resting ABI of <0.9, or exercise ABI falls by more than 0.1 (5) Reference vessel diameter of target lesion is &#8805;4.0 mm and &#8804;6.0 mm (6) Target lesion length is &#8804;150 mm. The target lesion should be treatable with one stent.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-TLF rate within 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYoko Ogata
Terumo Corporation Clinical Development Department
Outcome results
None listed