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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042200043
Enrollment
70
Registered
2020-09-10
Start date
2020-09-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis obliterans

Interventions

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

Sponsors

Inuzuka Kazunori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Contacts

Public ContactYuta Yamanaka

Hamamatsu University Hospital

yamanakaHM@hotmail.co.jp+81-53-435-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026