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

• Conditions: Peripheral Arterial Disease; Tissue Perfusion

• Registration Number: NCT05045365
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-06-02
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-11
• Last Update Submitted: 2021-09-11
• Study First Posted: 2021-09-16
• Last Update Posted: 2021-09-16
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perfusion of the index leg assessed by BOLD MRI before and after endovascular intervention.	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.	During operation	PBV can evaluate intraoperative perfusion quantitatively in real time.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China