INFINITY ISR

Investigation of the Optical Frequency Domain Imaging-guided drug-coated balloon therapy for femoropopliteal in-stent restenosis - INFINITY ISR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052799

Enrollment

100

Registered

2023-11-14

Start date

2022-08-09

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

In-stent restenosis: ISR

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Over 20 years old -Patients with symptomatic lower extremity arteriosclerosis obliterans (Rutherford Classification 2-5) -Patients treated with OFDI-guided DCB for ISR of the femoral popliteal artery (any type of stent presenting ISR)

Exclusion criteria

Exclusion criteria: -Lesions with confirmed stent fractures of type III or greater -Lesions with two or more stents stacked on top of each other -Lesions implanted with a combination of two or more stents

Design outcomes

Primary

Measure	Time frame
at 12-month follow-up	—

Countries

Japan

Contacts

Public ContactTatsuya Nakama

Tokyo Bay Urayasu Ichikawa Medical Center Cardiology

tatsuya_nakama@med.miyazaki-u.ac.jp047-351-3101

Outcome results