An Observational prospective Multicenter registry study on Outcomes of peripheral arTErial disease patieNts treated by AngioplaSty tHerapy in aortoIliac artery
- Conditions
- Peripheral artery disease
- Registration Number
- JPRN-UMIN000013849
- Lead Sponsor
- Research group on endovascular treatment in aortiliac artery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 1500
Not provided
1)Terminally ill patients expected to live less than one year 2)Restenosis from previous aortoiliac EVT 3)Patients considered likely to experience acute limb ischemia or acute thrombosis within one week of enrollment 4)Patients who have received EVT or vascular surgery within 30 days prior to treatment 5)Patients with untreated coagulation or significant bleeding disorders 6)Patients unable to receive anticoagulation or antiplatelet treatment 7)Patients who are or may be pregnant or lactating 8)WIQ and QOL questionnaires 9)Patients whose treatment side leg has already been amputated above the ankle 10)to participate in other clinical trials that could possible affect the scientific validity of this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoints -Primary patency rate of target vessel 12 months after index treatment -Primary and secondary patency rate of target vessel at 3 years after index treatment Primary safety endpoints -Major adverse events (MAE) occurring within 30 days after index treatment. MAE is defined as death, myocardial infarction (Q-wave and non-Q-wave), stroke, TVR, or major amputation of index limb. -MACE at 3 years after index treatment
- Secondary Outcome Measures
Name Time Method