臨床研究等提出・公開システム

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

Study on the endovascular visualization capability of an OFDI catheter

Hirata Ken-ichi

Kobe University Hospital

7-5-2, Kusunoki-cho, Chuo-ku, Kobe Hyogo

hiratak@med.kobe-u.ac.jp

Kawamori Hiroyuki

Kobe University Hospital

7-5-2, Kusunoki-cho, Chuo-ku, Kobe Hyogo

+81-78-382-5111

qqhv9s89k@dune.ocn.ne.jp

Not Recruiting

June. 07, 2019

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

(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

(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

Both

Patients who undergo endovascular treatment for PAD of lower extremities

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

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

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

+81-78-382-6669

April. 23, 2019

none