BEETLE

Prospective study of the clinical outcome of drug-coated Balloons for complEx lEsions in The reaL world clinical practicE - BEETLE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060656

Enrollment

300

Registered

2026-02-12

Start date

2025-11-04

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

DCB: Drug Coated Balloon

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age 20 years or older 2) Patients with symptomatic lower extremity peripheral arterial disease (Rutherford classification 2-5) 3) Lesions present from the superficial femoral artery to the distal popliteal artery 4) Femoral-popliteal artery lesions corresponding to TASC II C/D 5) Use of a drug-coated balloon (DCB) as the final device to fully cover the lesion

Exclusion criteria

Exclusion criteria: 1) Lesions involving aneurysms in target vessels 2) Expected survival period of 12 months or less 3) Cases of stent restenosis 4) Cases of acute lower extremity arterial occlusion 5) Cases where a debulking device is planned for use 6) Cases where provisional stent placement is planned

Design outcomes

Primary

Measure	Time frame
at 12-month follow-up	—

Countries

Japan

Contacts

Public ContactNaoki Hayakawa

Asahi General Hospital Cardiology

haya.naoki1981@gmail.com0479-63-8111

Outcome results