Ischemia Clinical Trial
— MR CLIOfficial title:
Clinical Use of Magnetic Resonance Perfusion Imaging to Qualitatively Assess Adequate Distal Perfusion After Endovascular Revascularization in Critical Limb Ischemia
Verified date | April 2023 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study evaluates the clinical effectiveness of Magnetic Resonance(MR) perfusion imaging to qualitatively assess adequate distal perfusion after endovascular revascularization in Critical Limb Ischemia
Status | Completed |
Enrollment | 65 |
Est. completion date | November 1, 2021 |
Est. primary completion date | July 13, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Age 20 and above - Critical limb ischemia with ulcer - Ankle brachial index(ABI) = 0.9 or Toe brachial index (TBI) = 0.5 or Transcutaneous oxygen pressure (TcPo2) = 40mmHg - = 70 percentage of stenosis of infrapopliteal artery on lower extremity computed tomography angiography or lower extremity doppler - Subject understands protocol and provides written, informed consent Exclusion Criteria: - Post-traumatic critical limb ischemia - Neurogenic limb ischemia - Life expectancy = 2 years |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seung-Whan Lee, M.D., Ph.D. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change of deoxyhemoglobin in MR imaging | 6 months | ||
Secondary | The event rate of unplanned major and minor amputation in limb | 6 months | ||
Secondary | The event rate of complete healing of lower extremity ulcer | 6 months |
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