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Study on the endovascular visualization capability of an OFDI catheter

Phase 3
Conditions
Patients who undergo endovascular treatment for PAD of lower extremities
Registration Number
JPRN-jRCT2052190025
Lead Sponsor
Hirata Ken-ichi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
20
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

(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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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