Clinical Trial in G-008 Femoro-popliteal Self-Expanding Stent System(G-008)
- Conditions
- Peripheral Arterial Disease in superficial femoral artery (SFA) and/or proximal popliteal artery
- Registration Number
- JPRN-UMIN000006774
- Lead Sponsor
- Johnson & Johnson K.K. Medical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
Exclusion Criteria of Patient: 1. Distal artery of the target vessel previously treated by stenting or bypass surgery. 2. Patient who is diagnosed with Acute Limb Ischemia (ALI) within seven days before treatment. 3. ABI >=0.9 at rest and post exercise. 4. Rutherford Classification Category 0, 1, 5 or 6. 5. Inability to tolerate antithrombotic or antiplatelet therapies. 6. Previous history of allergy to materials used in the investigational device. 7. Allergic to pharmaceuticals used in diagnostic or interventional catheterization. 8. Serum creatinine >2.0mg/dL. 9. Patient who is judged to be less likely to be able to comply with follow-up requirements specified in the protocol due to the risk of other comorbidities by principal investigator or subinvestigators. 10. Patient who is pregnant or has a possibility of pregnancy. 11. Known bleeding diathesis. 12. Patient enrolled in any other clinical trial, except for those whose follow-up have been completed. 13. Patient who is determined to be unsuitable for this study by principal investigator or subinvestigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method