Open-label multicenter registry on the Outcomes of in-stent restenosis treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery

Open-label multicenter registry on the Outcomes of in-stent restenosis treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery - Open-label multicenter registry on the Outcomes of in-stent restenosis treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery (ISLAND-SFA study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021121

Enrollment

Registered

2016-04-01

Start date

2016-04-01

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

peripheral arterial disease

Interventions

Optical Frequency Domain Imaging

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) patients with in-stent restenosis in superficial femoral artery. 2) peripheral arterial disease (Rutherford 1-5 categories) 3) patients meeting endovascular therapy criteria. 4) patients who can understand this study and provided written informed consent 5) patients aged over 20 years at the time of informed consent

Exclusion criteria

Exclusion criteria: 1)patients with in-stent occlusion in superficial femoral artery. 2)patients with all three occlusion artery below the knee 3)patients with uncontrollable heart failure 4)patients with acute limb ischemia or acute thrombotic occlusion 5)patients can not recieve antiplatelet therapy 6)female patients during pregnancy or breast-feeding 7)patients judged inappropriate for this study by physician

Design outcomes

Primary

Measure	Time frame
Restenosis with duplex ultrasonography at 6 months after balloon angioplasty	—

Secondary

Measure	Time frame
1)Rutherford category at 12 months after balloon angioplasty 2)Restenosis with duplex ultrasonography at 12 months after balloon angioplasty	—

Countries

Japan

Contacts

Public ContactKenichi Yanaka

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

yanadoushies@yahoo.co.jp078-382-5111

Outcome results

None listed

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