NIPH Clinical Trials Search

JRCT ID: jRCTs042200043

Registered date:10/09/2020

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedAtherosclerosis obliterans
Date of first enrollment18/02/2021
Target sample size70
Countries of recruitment
Study typeInterventional
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.


Primary OutcomeTreated 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 OutcomeOperative 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 maximumNot applicable
Include criteriaPatients 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 criteriaPersons 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


Public contact
Name Yuta Yamanaka
Address 1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2111
Affiliation Hamamatsu University Hospital
Scientific contact
Name Kazunori Inuzuka
Address 1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2111
Affiliation Hamamatsu University Hospital