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Shockwave: Disruption for A Better Fit
Sponsor: Cardiovascular Institute of the South Clinical Research Corporation
Summary
Recent clinical trial results demonstrate that IVL can increase lumen area by emitting sonic pressure waves, with less inflation pressure as compared to traditional angioplasty balloon dilation and resulting in minimal trauma to the vessel. Therefore, the use of IVL prior to placement of a stent for severely calcified femoral popliteal arteries may be associated with more successful stent implants and better long-term patency, resulting in a decrease in cardiovascular events. The investigator will evaluate the success by defining as lesion stenosis less than 30% and no evidence of Major Adverse Cardiac Event including death or any amputation of the index limb within 30 days of the procedure.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
0
Start Date
2020-12-07
Completion Date
2022-07-22
Last Updated
2026-05-27
Healthy Volunteers
Not specified
Conditions
Interventions
Shockwave Intravenous lithotripsy with a Supera stent
Pre-dilation with the option of using a 2-3mm balloon to cross a lesion for lithotripsy with the shockwave device followed by placement of supera stent.
Locations (1)
Cardiovascular Institute of the South
Houma, Louisiana, United States