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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOLD-MRI | Experimental | Blood Oxygen Level Dependent (BOLD)-MRI assessment of limb perfusion before and after standard of care endovascular therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOLD-MRI | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Enhanced oxygen reperfusion of the index foot assessed by BOLD MRI before and after endovascular intervention. | The BOLD MR T2* signal will be analyzed pre-and post-endovascular intervention to determine if it is able to detect a difference in foot oxygen perfusion levels. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krishna J Rocha-Singh, MD | St. John's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. John's Hospital | Springfield | Illinois | 62701 | United States |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |