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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045365
• Other study ID #: LBXZ-2105
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2021
• Source: Peking Union Medical College Hospital
• Contact: Bao Liu, M.D.
• Phone: 010-69152592
• Email: liubao72[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Tissue Perfusion

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfusion of the index leg assessed by BOLD MRI before and after endovascular intervention.	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
Primary	Perfusion of the index leg assessed by PBV before and after endovascular intervention.	PBV can evaluate intraoperative perfusion quantitatively in real time.	During operation
Secondary	The relationship between perfusion and function of the lower limb in PAOD patients	The preoperative and postoperative motor functions of the patients were tested to analyze the functional impact of perfusion improvement.	1 year