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OpenTrials
Completed

NCT Number: NCT02646150

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

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

Completed

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Key information

Conditions

Lower Limb Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Perfusion Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Perfusion Imaging

Procedure

Primary outcomes

  1. The change of deoxyhemoglobin in MR imaging

    Time frame: 6 months

Secondary outcomes

  1. The event rate of unplanned major and minor amputation in limb

    Time frame: 6 months

  2. The event rate of complete healing of lower extremity ulcer

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Seung-Whan Lee, M.D., Ph.D.

Other

Registry information

Acronym: MR CLI

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2016
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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