Prevention of the elastic recoil after balloon angioplasty for infrapopliteal zone in patients with chronic limb threateing ischemia

Prevention of the elastic recoil after balloon angioplasty for infrapopliteal zone in patients with chronic limb threateing ischemia - RECOIL ZERO study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059284

Enrollment

150

Registered

2025-10-03

Start date

2025-05-10

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

Chronic limb threatening ischemia (Below-the-knee)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with symptomatic lower limb occlusive atherosclerosis (Rutherford classification 4-6) for whom below-knee arterial EVT is indicated 2) Patients for whom HP-POBA is determined to be the medically optimal treatment (best practice) for symptomatic atherosclerotic lesions in the below-knee arteries, and for whom HP-POBA is actually planned (Patients may also be enrolled if treatment of other arterial regions is planned concurrently)

Exclusion criteria

Exclusion criteria: 1) Patients for whom limb salvage is unlikely (e.g., due to infection complications) 2) Lesions involving aneurysms in the target vessel

Design outcomes

Primary

Measure	Time frame
The presence or absence of elastic recoil confirmed by angiography 15 minutes later	—

Secondary

Measure	Time frame
Incidence of procedural complications	—

Countries

Japan

Contacts

Public Contacttoru matsumura

Clinicalcore Non

matsumura@clinicalcore.jp03-6667-0250

Outcome results