Peripheral artery disease
Conditions
Interventions
None listed
Sponsors
Research group on endovascular treatment in aortiliac artery
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 30 days, 6 months, and 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 with iliac artery restenosis equal to or greater than 50% 6)Patients approved for treatment with aortoiliac stents 7)Patients classified as Rutherford class 2-4
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKaori Shimogama
Japan Endovascular Treatment Conference Office of OMOTENASHI Registry
Outcome results
None listed