Open-label multicenter registry on the Outcomes of peripheral arterial disease treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery
Not Applicable
- Conditions
- peripheral arterial disease
- Registration Number
- JPRN-UMIN000021120
- Lead Sponsor
- Department of Internal Medicine, Kobe University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1)terminal illness in whom life expectancy is expected to be less than 6 months 2)previous stent implantation in the targeted SFA lesion 3)acute limb ischemia or acute thrombotic occlusion 4)patients with no arterial runoff below the knee 5)patients with uncontrollable heart failure 6)patients can not recieve antiplatelet therapy 7)female patients during pregnancy or breast-feeding 8)patients who are judged inappropriate for this trial by their attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method presence of restenosis by ultrasound at 6 months after balloon angioplasty
- Secondary Outcome Measures
Name Time Method Rutherford category at 6 months after balloon angioplasty