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
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Perfusion of the index leg assessed by BOLD MRI before and after endovascular intervention.
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 35 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)