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

NCT05045365 | Unknown

• 1 other identifier: LBXZ-2105
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Tissue Perfusion

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• The relationship between perfusion and function of the lower limb in PAOD patients

  1 year

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Bao Liu, M.D.

CONTACT

010-69152592; liubao72@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: September 16, 2021
• Study Start: December 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

CN (1)