NCT02601430

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 19 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peripheral Arterial Disease
• Critical Limb Ischemia

Interventions

Type	Name	Description
OTHER	BOLD-MRI	A fixed air cuff will be placed on the index limb at the level of the calf and will be inflated to a level which induces the loss of the pedal Doppler signal. Inflation will be maintained for 180 seconds, then will be rapidly deflated and BOLD MR imaging will be initiated.

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-11-10
• Last updated: 2017-10-12

Locations

1 site across 1 country: United States