ovel Insight into Revascularization Strategy - Target region Oxygenation-based Endovascular treatment
Not Applicable
Recruiting
- Conditions
- Atherosclerosis obliterans
- Registration Number
- JPRN-jRCTs042200043
- Lead Sponsor
- Inuzuka Kazunori
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion 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.
Exclusion 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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).