Lower LimbMR CLINCT02646150
Clinical Use of Magnetic Resonance Perfusion Imaging to Qualitatively Assess Adequate Distal Perfusion After Endovascular Revascularization in Critical Limb Ischemia
An observational study of Lower Limb and Ischemia, run by Seung-Whan Lee, M.D., Ph.D. at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lower Limb, Ischemia, Perfusion
- What is being tested?
- Magnetic Resonance Perfusion Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Dec 2015to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lower extremity ischemia
Who may be able to join
- 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
Who cannot join
- Post-traumatic critical limb ischemia
- Neurogenic limb ischemia
- Life expectancy ≤ 2 years
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Lower Limb, Ischemia, Perfusion
- Being tested
- Magnetic Resonance Perfusion Imaging
- Keywords
- Magnetic Resonance perfusion imaging, distal perfusion, Critical Limb Ischemia, endovascular revascularization
- Medical subject headings
- Ischemia, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Perfusion ImagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| critical limb ischemia | Not described Receives: Procedure: Magnetic Resonance Perfusion Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of deoxyhemoglobin in MR imaging
Measured: 6 months
Secondary outcomes (2)
The event rate of unplanned major and minor amputation in limb
Measured: 6 months
The event rate of complete healing of lower extremity ulcer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study start12 Dec 2015
- Primary completion13 Jul 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Whan Lee, M.D., Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seung-Whan Lee, M.D., Ph.D., Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646150
- Sponsor's protocol ID
- AMCCV2015-10
- Acronym
- MR CLI
- Status last verified
- Apr 2023
- First submitted
- 4 Jan 2016
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This trial is not publicly funded clinical trial.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Use of Magnetic Resonance Perfusion Imaging to Qualitatively Assess Adequate Distal Perfusion After Endovascular Revascularization in Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT02646150
- Acronym / sponsor ID
- MR CLI / AMCCV2015-10
- Conditions
- Lower Limb, Ischemia, Perfusion
- Keywords
- Magnetic Resonance perfusion imaging, distal perfusion, Critical Limb Ischemia, endovascular revascularization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Seung-Whan Lee, M.D., Ph.D.University, hospital or other
- Study start
- 12 Dec 2015 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critical limb ischemia | – | Procedure: Magnetic Resonance Perfusion Imaging |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lower extremity ischemia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Post-traumatic critical limb ischemia
- Neurogenic limb ischemia
- Life expectancy ≤ 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Perfusion Imaging | Procedure or surgery | critical limb ischemia |
Primary outcome
The change of deoxyhemoglobin in MR imaging
Time frame: 6 months
2 secondary outcomes
The event rate of unplanned major and minor amputation in limb
Time frame: 6 months
The event rate of complete healing of lower extremity ulcer
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No. This trial is not publicly funded clinical trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb and Ischemia, run by Seung-Whan Lee, M.D., Ph.D. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of deoxyhemoglobin in MR imaging (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.