Novel Insight into Revascularization Strategy - Target region Oxygenation-based Endovascular treatment

JRCT ID: jRCTs042200043

Registered date:10/09/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Atherosclerosis obliterans
• Date of first enrollment: 18/02/2021
• Target sample size: 70
• Study type: Interventional

Intervention(s)

In revascularization surgery, the anterior tibial artery, posterior tibial artery, and peroneal artery regions are subjected to preoperative TOE- 20 to measure rSO2 levels.
2. all patients were given TOE-20 before the start of surgery in the anterior tibial, posterior tibial, and peroneal artery region, the most The patient is placed in a position where the rSO2 value is low, and the rSO2 is monitored.
The principal investigator (sub-investigator) confirms the allocation and begins the surgery. The TOE group will receive a routine revascularization procedure. When the value exceeds 50%, treatment is terminated and the non-TOE group is monitored with rSO2 Perform revascularization according to the preoperative plan, regardless of whether it is performed or not.
4. the primary and secondary endpoints on the next day, 7 days, 1 month, 3 months, and 6 months after surgery Evaluate and, if necessary, administer additional treatment.

Outcome(s)

• Primary Outcome: Treated lower extremity events (with or without revascularization, amputation, extravascular leakage, and restenosis) presence or absence, dissection, thrombus formation, bleeding, device damage, and surgery-related infection, presence or absence, presence of lymphatic leakage) Incidence at 6 months.
• Secondary Outcome: Operative time, length of hospital stay, X-ray time, contrast agent usage, Hospitalization costs (volume) during revascularization, wound reduction and healing, time to ulcer healing, pain improvement (Numerical Rating Scale), major amputation avoidance overall survival, post-operative glomerular filtration rate (GFR), and ankle and pedal artery pressure (ABI).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients with Atherosclerosis obliterans who are scheduled to undergo endovascular treatment.
Men and women over 20 years old.
Rutherford Classification 5 and 6 patients.
When a signed consent form has been obtained from the subject or his or her authorized representative regarding this research, or when a consent form has been signed by the subject or his or her authorized representative.

Exclude criteria

Persons with systemic or foot infections.
Preoperatively, the rSO2 value of all the measured sites is 50% or more.
The patient is scheduled to undergo revascularization surgery under general anesthesia.
Pregnancy and potential pregnancy.
The researcher who is responsible for the research has decided that it is inappropriate.

Related Information

• Primary Sponsor: Inuzuka Kazunori
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development