Patients with peripheral artery disease (PAD) associated with critical limbs ischemia (CLI)
Conditions
Interventions
None listed
Sponsors
OLIVE Registry Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a.Patients who can provide an informed consent and are aged 20 years or older when providing the consent b.CLI has been diagnosed, and revascularization with EVT is indicated. c.Revascularization in infra-popliteal arteries with EVT was conducted or was to be conducted. d.Follow-up for one year or longer is considered feasible.
Exclusion criteria
Exclusion criteria: << 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactOsamu Iida
Kansai Rosai Hospital division of cardiovascular disease
Outcome results
None listed