The significance of OptiCal FrEquency DomAin ImagiNg Findings for Predicting the Patency in Femoropopliteal Lesions Treated with Drug Coated Balloon : A Prospective Multicenter Study

Not Applicable

Recruiting

• Conditions: Arteriosclerosis obliterans

• Registration Number: JPRN-UMIN000047292
• Lead Sponsor: Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-01
• Last Update Posted: 17 October 2023
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients who are terminally ill and expected to live less than one year 2) Patients with acute lower limb ischemia or acute thrombosis 3) In-stent stenosis or occlusive lesions 4) Critically ill ischemic limb with suspected Rutherford Category 6 or extensive infection 5) Anastomotic lesions after bypass surgery 6) Patients who have difficulty continuing antiplatelet therapy (e.g., patients with planned surgical procedures requiring antiplatelet drug withdrawal within one month) 7) Patients who are or may be pregnant or breastfeeding 8) Patients who have or may have hypersensitivity to drug-eluting balloons, paclitaxel or its structural analogs, additives, or contrast media 9) Other patients who are judged inappropriate for inclusion by the study investigator

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary patency

Secondary Outcome Measures

Name	Time	Method
At 12 months after treatment 1) Avoidance rate of restenosis assessed by echocardiography 2) Clinically driven TLR (target lesion revascularization) rate 3) Clinically driven target vessel revascularization (TLR) rate 4) Surgical revascularization rate 5) Incidence of acute thrombotic occlusion 6) Incidence of major lower extremity amputations (amputations central to the ankle joint) 7) Major adverse limb event (MALE [major adverse limb event]: any re-intervention or major amputation) rate 8) Rutherfurd classification 9) Adverse event rate (1) All deaths, (2) deaths from cardiovascular disease, (3) presence of stroke/systemic embolism, (4) hospitalization for cardiac disease, (5) presence of intracranial hemorrhage