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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05045365

Enrollment

Registered

2021-09-16

Start date

2020-12-01

Completion date

2023-06-30

Last updated

2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease, Tissue Perfusion

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

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;

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactBao Liu, M.D.

liubao72@aliyun.com010-69152592

Outcome results