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BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI

Peripheral Arterial Disease Clinical Trial

Official title:
Functional Magnetic Resonance Angiographic Imaging Using Blood Oxygen Level Determination (BOLD) Assessment as a Surrogate of Improved Skeletal Muscle Oxygenation After Endovascular Therapy for the Treatment of Chronic Lower Limb Ischemia

Clinical Trial Summary

The purpose of this study is to determine if an MRI technique called Blood Oxygen Level Dependent, or BOLD, can be used to evaluate blood flow in the leg before and after treatment with standard endovascular therapy in patients with chronic lower limb ischemia.

Clinical Trial Description

This study is a prospective single arm, open label registry to evaluate the feasibility of blood oxygen level dependent (BOLD) magnetic resonance imaging for the assessment of a potentially new functional surrogate of altered lower limb skeletal muscle oxygenation after a successful percutaneous endovascular intervention. Baseline MRI assessment using the BOLD technique will be performed on qualified subjects prior to undergoing a standard of care endovascular therapy. Post-procedure BOLD-MRI assessment will also be performed at 30 days and either 90 or 180 days post-procedure. Post-MR image acquisition processing and analysis will be performed, using pre-determined algorithms, by a core laboratory. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02601430
Study type Interventional
Source Zimmer Biomet
Contact
Status Completed
Phase N/A
Start date February 2016
Completion date October 2016
View Details
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