BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI
Completed · Not applicable
Conditions studied: Peripheral Arterial Disease, Critical Limb Ischemia
In brief
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.
Key facts
- Study ID
- NCT02601430
- Run by
- Zimmer Biomet
- People needed
- 5
- Starts
- 2016-02-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2017-10-12
Who can join
Age: 19 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 and < 90 years
- Subject has been informed of the nature of the study and agreed to participate and has signed an IRB approved consent form
- Subject understands the duration of the study and its follow-up visit requirements and agrees to comply
- Subject has documented chronic limb ischemia in the target limb with Rutherford Category 2-5 and pulse plethysmography (PPG), pulse volume recording (PVRs), TcPO2, ABIs or toe pressures and symptoms that conform to the diagnosis of life-style limiting claudication or critical limb ischemia
You may not qualify if…
- Adult subjects who lack the capacity to consent for themselves
- Women who are pregnant or wish to become pregnant during the course of the study. (Women of child-bearing potential must undergo pregnancy testing at the time of enrollment, and be counseled in appropriate measures to avoid becoming pregnant for the duration of the study)
- Subjects with contraindications to MR imaging procedures (including the administration of gadolinium based contrast agents)
- Subjects suspected to be unable to withstand the reactive hyperemia protocol
Where it is running
- St. John's Hospital — Springfield, Illinois, United States
Full record on ClinicalTrials.gov
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