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Clinical Trials/NCT02646150
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

Registry
clinicaltrials.gov
Start Date
December 12, 2015
End Date
November 1, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Seung-Whan Lee, M.D., Ph.D.
Responsible Party
Sponsor Investigator
Principal Investigator

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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