Peripheral Arterial Disease in superficial femoral artery (SFA) and/or proximal popliteal artery
Conditions
Interventions
Stent
POBA
Sponsors
Johnson & Johnson K.K. Medical Company
ENDO CORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria of Patient: 1. Age >=20, male or female. 2. Getting informed consent from a patient or legal guardian. 3. Patient who is willing and able to comply with all follow-up requirements. 4. One lesion per limb. 5. Maintaining patency of ipsilateral iliac artery. 6. Rutherford Classification Category 2-4 (including ischemic pains at rest). 7. Maintaining patency of ipsilateral mid/distal popliteal artery and at least one of fibular or tibial arteries with no planned intervention. Inclusion Criteria of Lesion: 1. Significant stenotic lesion in the femoro-popliteal artery. 2. Target lesion apart from the origin of SFA >=10mm. 3. Lesion length >=40mm to <=150mm. 4. Reference vessel diameter >=4.0mm and <=7.5mm. 5. No obvious thrombus observed in the target vessel by angiography.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-TLF rate during 12 months after procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success, Procedure success, Evaluation of ABI, Rutherford classification, Patency rate, Acute gain, QOL | — |
Countries
Japan
Contacts
Public ContactIizumi Misuzu
Johnson & Johnson K.K. Medical Company Clinical Operation
Outcome results
None listed