Endovascular Treatment for Infra-inguinal Vessel, in patients with critical limb ischemia, - A Prospective, Multi-center, 12 month follow-up Registry in Japan
- Conditions
- Patients with peripheral artery disease (PAD) associated with critical limbs ischemia (CLI)
- Registration Number
- JPRN-UMIN000002830
- Lead Sponsor
- OLIVE Registry Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Not provided
<< Exclusion criteria for patients >> e.Patients with any limb which has already undergone major amputation due to ischemic disease f.Patients with CLI in both limbs in which ischemic ulcer or gangrene is observed. g.Patients who are considered to have the life expectancy of one year or shorter. h.Patients in whom QOL evaluation is difficult due to dementia or the other reason. i.Patients who may not allow long-term follow-up << Exclusion criteria for the affected limb >> j.Affected limbs in which ischemic ulcer or gangrene widely spreads beyond the tarsometatarsal region k.Affected limbs which have undergone EVT in the lower limb arteries including the abdominal aorta and iliac artery and/or femoral artery in the affected limb for the last four weeks l.Affected limbs which are to undergo EVT as pre-treatment of the major lower limb amputation, or of which the major lower limb amputation is considered inevitable regardless of EVT practice. m.Affected limbs which have undergone EVT in the abdominal aorta or iliac artery concurrently with EVT in the infra-inguinal arteries
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate free of major lower limb amputation at 12 months after the EVT. This means that a patient survives without undergoing major lower limb amputation.
- Secondary Outcome Measures
Name Time Method