JPRN-jRCTs052230061
Recruiting
N/A
An exploratory clinical study on histological characterization of atheroscrelotic plaque of lower extremity artery using optical coherence tomography and directional coronary atherectomy
Otake Hiromasa0 sites4 target enrollmentJuly 3, 2023
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- ower extremity artery disease
- Sponsor
- Otake Hiromasa
- Enrollment
- 4
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) LEAD patients scheduled to undergo elective EVT with OFDI for femoropopliteal or below\-knee artery lesions
- •(2\) Patients whose lesions to be treated were determined to be non\-calcified lesions
- •(3\) Patients with lesions \>4 mm in reference vessel diameter on preoperative angiography or CT examination
- •(4\) Patients who are 18 years of age or older at the time of informed consent
- •(5\) Patients who can understand the content of the treatment and the purpose of the research, and who are able to obtain written informed consent of their own free will.
Exclusion Criteria
- •(1\) Patients with acute limb ischemia or acute thrombosis
- •(2\) In\-stent restenosis or occlusive lesion
- •(3\) Restenosis or occlusive lesion following balloon anigoplasty
- •(4\) Rutherford Category 6, or critical limb ischemia suspected of widespread infection
- •(5\) Patients who find it difficult to continue antiplatelet therapy (such as patients planning surgery that requires withdrawal of antiplatelet agents within one month)
- •(6\) Patients who are pregnant/lactating or may be pregnant
- •(7\) Other patients who are judged inappropriate by the principle investigator or co\-investigators
Outcomes
Primary Outcomes
Not specified
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