Perfusion Assessment Using BOLD MRI and PBV in Endovascular Treatment of Peripheral Arterial Occlusive Disease

September 11, 2021 updated by: Peking Union Medical College Hospital

A Prospective Study: Perfusion Assessment Using Blood Oxygen Level Dependent Functional Magnetic Resonance Angiographic Imaging and Parenchymal Blood Volume Imaging in Endovascular Treatment of Peripheral Arterial Occlusive Disease

Current assessment of lower limb ischemia cannot reflect the location and degree of ischemia. Tissue perfusion assessment was used in the diagnosis and treatment of lower limb ischemia in this project, and the quantitative evaluation of ischemia degree was realized by using its advantages of quantitative analysis and perfusion imaging.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study was conducted in PAOD patients aged 35 to 80 years with clinical symptoms such as claudication, resting pain, or ulceration, who were intended for endovascular treatment. Computed tomographic angiography disclosed the occlusive lesion in their target lesion. Subject with complex infrapopliteal lesions was excluded in order to reduce the influence of other variables.

Description

Inclusion Criteria:

  • Subject has been diagnosed as PAOD by symptom and imaging;
  • Subject intends to take endovascular treatment in PUMCH;
  • Subjects without heavy stenosis in infrapopliteal artery (stenosis<30%), or with short length lesion(length≤5cm, stenosis≥30%);
  • Age > 35 and < 80;
  • Subject has been informed the study and has signed informed consent;

Exclusion Criteria:

  • Subject with MRI contraindications or allergic to iodinated contrast medium;
  • Subject underwent intervention therapy or angioplasty in target vessel within the last 3 months;
  • Subject after stent implantation in superficial femoral artery;
  • Subject with severe heart dysfunction, renal dysfunction, or cancer;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perfusion of the index leg assessed by BOLD MRI before and after endovascular intervention.
Time Frame: 1 year
BOLD evaluates perfusion noninvasively and can be used for long-term monitoring and postoperative follow-up. Improving the perfusion assessment will improve the evaluation system for endovascular treatment of PAOD.
1 year
Perfusion of the index leg assessed by PBV before and after endovascular intervention.
Time Frame: During operation
PBV can evaluate intraoperative perfusion quantitatively in real time.
During operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relationship between perfusion and function of the lower limb in PAOD patients
Time Frame: 1 year
The preoperative and postoperative motor functions of the patients were tested to analyze the functional impact of perfusion improvement.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

June 2, 2021

First Submitted That Met QC Criteria

September 11, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 11, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBXZ-2105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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