Study on the endovascular visualization capability of an OFDI catheter

JRCT ID: jRCT2052190025

Registered date:03/06/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Patients who undergo endovascular treatment for PAD of lower extremities
• Date of first enrollment: 07/06/2019
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Taking an image of the vessel lumen with an OFDI catheter.

Outcome(s)

• Primary Outcome: Technical success (observation of the blood vessel lumen over 3/4 round)
• Secondary Outcome: (1) Technical success by each treatment region , (2) Operational success, (3) Confirmation of image picture, (4) Adverse event and failure

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include 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
• Exclude 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

Related Information

• Primary Sponsor: Hirata Ken-ichi
• Source(s) of Monetary Support: Terumo Corporation