Lower extremity artery disease Lower extremity artery disease
Conditions
Interventions
Sponsors
Otake Hiromasa
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imaging findings by OFDI and plaque tissue characterization by DCA | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoint: intravascular ultrasound findings Safety endpoint: Presence or absence of complications during the procedure or perioperative period, malfunction of equipment, other unexpected diseases, etc. | — |
Contacts
Public ContactTakayoshi Toba
Kobe university hospital
Outcome results
None listed