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Clinical Trials/NCT05045365
NCT05045365
Unknown
N/A

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

Peking Union Medical College Hospital1 site in 1 country50 target enrollmentDecember 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
Peking Union Medical College Hospital
Enrollment
50
Locations
1
Primary Endpoint
Perfusion of the index leg assessed by BOLD MRI before and after endovascular intervention.
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
June 30, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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;

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • The relationship between perfusion and function of the lower limb in PAOD patients(1 year)

Study Sites (1)

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