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EVUS guided wiring vs. knuckle wiring for femoropopliteal chronic total occlusive lesion

EVUS guided wiring vs. knuckle wiring for femoropopliteal chronic total occlusive lesion - EPOCH study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045983
Enrollment
200
Registered
2021-11-05
Start date
2021-04-27
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

peripheral artery disease

Interventions

EVUS guided wiring Knuckle wiring

Sponsors

Toyohashi heart center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Symptomatic PAD, including restenosis after POBA 2) Obstructive lesions in the femoral popliteal artery 3) The popliteal artery contains the P1-2 segment 4) Being 20 years old or older at the time of obtaining consent 5) Chronic limb threatening ischemia (CLTI) Rutherford Classification 4

Exclusion criteria

Exclusion criteria: 1) Patients with acute lower limb ischemia or acute thrombosis 2) Patients with a history of stent placement for the target blood vessel 3) Patients with non-arteriosclerotic stenosis and obstructive lesions 4) Patients who have difficulty taking antiplatelet drugs / anticoagulants 5) Chronic limb threatening ischemia (CLTI) Rutherford classification 5 or 6 6) When the doctor in charge judges that it is inappropriate 7) Cases in which blood vessels cannot be visualized with EVUS

Design outcomes

Primary

MeasureTime frame
Primary patency rate (at 1 month, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months)

Secondary

MeasureTime frame
Freedom from TLR MACLE Wire passage route evaluated by IVUS Degree of dissection after balloon dilation, angiographic findings, IVUS findings Procedure time, radiation exposure, contrast medium usage Procedure complications Improvement of patient symptoms by Rutherford classification Improvement of ABI

Countries

Japan

Contacts

Public ContactShinsuke Mori

Saiseikai Yokohama City Eastern Hospital Cardiology

hello_morisun@yahoo.co.jp045-576-3000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026