NCT02646150

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

5.6 years

First QC Date

January 4, 2016

Last Update Submit

April 10, 2023

Conditions

Lower LimbIschemiaPerfusion

Keywords

Magnetic Resonance perfusion imagingdistal perfusionCritical Limb Ischemiaendovascular revascularization

Outcome Measures

Primary Outcomes (1)

  • The change of deoxyhemoglobin in MR imaging

    6 months

Secondary Outcomes (2)

  • 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 Arms (1)

critical limb ischemia

Procedure: Magnetic Resonance Perfusion Imaging

Interventions

Magnetic Resonance Perfusion ImagingPROCEDURE
critical limb ischemia

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with lower extremity ischemia

You may qualify if:

  • 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

You may not qualify if:

  • Post-traumatic critical limb ischemia
  • Neurogenic limb ischemia
  • Life expectancy ≤ 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

IschemiaChronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPeripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease Attributes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Division of Cardiology

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 5, 2016

Study Start

December 12, 2015

Primary Completion

July 13, 2021

Study Completion

November 1, 2021

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

This trial is not publicly funded clinical trial.

Locations

KR(1)