A Prospective Single-Arm Multicenter StuDy to Evaluate the Performance of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular lesions located in the infrapoplitEal Arteries beLow the knee (DEEPER REVEAL)
DEEPER REVEAL - Bare Temporary Spur Stent System in Treating Patients with Critical Limb Ischemia (CLI)
Sponsor: Reflow Medical, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAU3829
U.S. Govt. ID: NCT05358353
Contact: Kerianne Nordland: 212-305-7061 / kn2600@cumc.columbia.edu
Additional Study Information: The objective of this study is to learn more about how safe and effective the Bare Temporary Spur Stent System is when used in patients who have blocked arteries in their lower limbs. The selection of subjects will be those with Critical Limb Ischemia (CLI), a form of Peripheral Arterial Disease (PAD) in which an artery (blood vessel) in the lower leg (calf) may have become blocked. To improve blood flow to the lower leg, the study doctor will open up this blockage using the Bare Temporary Spur Stent System.
Investigator
Sahil Parikh, MD
Do You Qualify?
Have you had a diagnosis of critical limb ischemia? Yes No
Have you been scheduled for a peripheral angiogram? Yes No
Do you have a wound that is only confined to foot below the ankle? Yes No
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For more information, please contact:
Kerianne Nordland
kn2600@cumc.columbia.edu
212-305-7061
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