An exploratory study on the molecular biological characteristics of lower extremity atherosclerosis

JRCT ID: jRCTs052230062

Registered date:03/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lower extremity artery disease
• Date of first enrollment: 08/09/2023
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Directional coronary atherectomy, which is not covered by insurance, is used to collect arterial plaque from the lower extremities.

Outcome(s)

• Primary Outcome: Molecular biological characteristics in single-cell RNA sequence analysis of lower extremity atheroscrelotic plaque obtained by DCA (Comprehensive analysis of disease-related genes or mRNA)
• Secondary Outcome: Safety endpoint: Presence or absence of complications during the procedure or perioperative period

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) LEAD patients scheduled to undergo elective EVT for femoropopliteal or below-knee ar
tery 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.

Exclude criteria

(1) Patients with acute limb ischemia or acutethrombosis
(2) In-stent stenosis or occlusive lesion
(3) Rutherford Category 6, or Critical limb ischemia suspected of widespread infection
(4) Patients who find it difficult to continue antiplatelet therapy (such as patients planning surgery that requires withdrawal of antiplatelet agents within one month)
(5) Patients who are pregnant/lactating or may be pregnant
(6) Other patients who are judged inappropriate by the principle investigator or subinvestigator

Related Information

• Primary Sponsor: Otake Hiromasa