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NCT02646150 Clinical Trial

Clinical Use of Magnetic Resonance Perfusion Imaging to Qualitatively Assess Adequate Distal Perfusion After Endovascular Revascularization in Critical Limb Ischemia

Ischemia Clinical Trial

— MR CLI  

Official title:
Clinical Use of Magnetic Resonance Perfusion Imaging to Qualitatively Assess Adequate Distal Perfusion After Endovascular Revascularization in Critical Limb Ischemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02646150
Other study ID # AMCCV2015-10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 12, 2015
Est. completion date November 1, 2021

Study information
Verified date April 2023
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Magnetic Resonance Perfusion Imaging

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seung-Whan Lee, M.D., Ph.D.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
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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