Skip to content

Study on the endovascular visualization capability of an OFDI catheter

Multi-center, open-label, single-arm study on the endovascular visualization capability of an OFDI (Optical Frequency Domain Imaging) catheter for obstructive arteriosclerosis of lower extremities

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2052190025
Enrollment
20
Registered
2019-06-03
Start date
2019-06-07
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

Patients who undergo endovascular treatment for PAD of lower extremities

Interventions

Taking an image of the vessel lumen with an OFDI catheter.

Sponsors

Hirata Ken-ichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients who undergo endovascular treatment based on guidelines for the management of PAD (peripheral arterial diseases) (JCS 2015) (2) Patients whose target lesion site exists from the superficial femoral artery to the peripheral side (3) Patients who are at least 20 years at the time of consent acquisition

Exclusion criteria

Exclusion criteria: (1) Patients who have a history of bypass surgery (2) Patients with endovascular treatment (stent placement excluding balloon treatment) for PAD of lower extremities in the past and re-treat the same lesion (3) Patients who have serious allergies to contrast (4) Patients who have renal dysfunction with eGFR (MDRD calculation formula) less than 30 mL / min / 1.73 m2 (5) Patients with platelet count less than 100000 / microL (6) Patients contraindicated for antiplatelet or anticoagulant therapy (7)Patients decided not applicable for this study by physician

Design outcomes

Primary

MeasureTime frame
Technical success (observation of the blood vessel lumen over 3/4 round)

Secondary

MeasureTime frame
(1) Technical success by each treatment region , (2) Operational success, (3) Confirmation of image picture, (4) Adverse event and failure

Contacts

Public ContactHiroyuki Kawamori

Kobe University Hospital

qqhv9s89k@dune.ocn.ne.jp+81-78-382-5111

Outcome results

None listed

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