peripheral artery disease with intermittent claudication
Conditions
Interventions
None listed
Sponsors
Okayama University Department of Cardiovasclar medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients diagnosed with PAD 2)Patients aged 20 years or older when providing consent 3)Patients providing written consent indicating understanding of and agreement to participate in the study, and willing to undergo follow up at 1, 2, and 3 years after index treatment 4)Patients with an index limb ABI equal to or lower than 0.9, or definite diagnosis of PAD in accordance with ACCF/AHA guidelines if ABI is greater than 0.9. 5)Patients have symptoms including claudication and rest leg pain.
Exclusion criteria
Exclusion criteria: 1)Terminally ill patients expected to live less than one year EVT 2)Patients with ischemic ulcer or gangreen 3)Patients with untreated coagulation or significant bleeding disorders and patients unable to receive anticoagulation or antiplatelet treatment 4)Patients who are or may be pregnant or lactating 5)Patients whose treatment side leg has already been amputated above the ankle 6)to participate in other clinical trials that could possible affect the scientific validity of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rate of target vessel 12 months after EVT | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of leg symptom 12 months after EVT. Major adverse events (MAE) occurring within 3years after index treatment. MAE is defined as death, myocardial infarction (Q-wave and non-Q-wave), stroke, TVR, or major amputation of index limb Improvement of leg symptom assessed by 6 minutes walking test The change in femoral and the below-knee circumference | — |
Countries
Japan
Contacts
Public ContactHironobu Toda
Okayama University Department of Cardiovaclar medicine
Outcome results
None listed