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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047292

Enrollment

180

Registered

2022-05-01

Start date

2022-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriosclerosis obliterans

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with atherosclerosis obliterans who have undergone OFDI-guided EVT using DCB on a standby basis for lesions in the femoral-patellar artery territory 2) Patients who are 20 years of age or older at the time of consent. 3) Patients who understand the treatment and purpose of the study and are able to give consent

Exclusion criteria

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) Angiographically severe calcification defined as the peripheral arterial calcium scoring system (PACSS) grade 4 (2) 7) Patients who have difficulty continuing antiplatelet therapy (e.g., patients with planned surgical procedures requiring antiplatelet drug withdrawal within one month) 8) Patients who are or may be pregnant or breastfeeding 9) Patients who have or may have hypersensitivity to drug-eluting balloons, paclitaxel or its structural analogs, additives, or contrast media 10) Other patients who are judged inappropriate for inclusion by the study investigator

Design outcomes

Primary

Measure	Time frame
Primary patency	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactTakayoshi Toba

Kobe University Graduate School of Medicine Division of Cardiovascular Medicine, Department of Internal Medicine

taka02222003@yahoo.co.jp09051218725

Outcome results