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

Open-label multicenter registry on the Outcomes of peripheral arterial disease treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery - Open-label multicenter registry on the Outcomes of peripheral arterial disease treated by Balloon angioplasty with Optical Frequency Domain Imaging in superficial femoral artery (OCEAN-SFA study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021120

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 diagnosed as peripheral arterial disease and scheduled endvascular therapy for de novo superficial femoral artery lesions 2)patients aged over 20 years at the time of informed consent 3)patients who can undestand this study and provide informed consent written 4)ankle brachial index 0.9 5)PAD(Tasc A or B categories) 6)PAD(Rutherford 1-5 categories)

Exclusion criteria

Exclusion criteria: 1)terminal illness in whom life expectancy is expected to be less than 6 months 2)previous stent implantation in the targeted SFA lesion 3)acute limb ischemia or acute thrombotic occlusion 4)patients with no arterial runoff below the knee 5)patients with uncontrollable heart failure 6)patients can not recieve antiplatelet therapy 7)female patients during pregnancy or breast-feeding 8)patients who are judged inappropriate for this trial by their attending physician

Design outcomes

Primary

Measure	Time frame
presence of restenosis by ultrasound at 6 months after balloon angioplasty	—

Secondary

Measure	Time frame
Rutherford category at 6 months after balloon angioplasty	—

Countries

Japan

Contacts

Public ContactYoshiro Tsukiyama

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

yoshiro.tsukiyama0920@gmail.com078-382-5111

Outcome results

None listed

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