NCT02646150
Completed
Not Applicable
Clinical Use of Magnetic Resonance Perfusion Imaging to Qualitatively Assess Adequate Distal Perfusion After Endovascular Revascularization in Critical Limb Ischemia
Seung-Whan Lee, M.D., Ph.D.1 site in 1 country65 target enrollmentDecember 12, 2015
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lower Limb
- Sponsor
- Seung-Whan Lee, M.D., Ph.D.
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- The change of deoxyhemoglobin in MR imaging
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
Investigators
Seung-Whan Lee, M.D., Ph.D.
Division of Cardiology
Asan Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
The change of deoxyhemoglobin in MR imaging
Time Frame: 6 months
Secondary Outcomes
- The event rate of unplanned major and minor amputation in limb(6 months)
- The event rate of complete healing of lower extremity ulcer(6 months)
Study Sites (1)
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