Shockwave: Disruption for A Better Fit

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The purpose of this study is to evaluate the immediate and long term effectiveness of using intravenous lithotripsy followed by the placement of a Supera stent for the treatment of calcified femoral popliteal arteries. The use of IVL and Supera stent will be predetermined by the investigator according to inclusion criteria and the need for treatment and stenting combined, will be confirmed through the use of intravascular ultrasound and the investigators judgment for best practice. Following enrollment and index procedure, the subject will be followed prospectively for one year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05147363
Study type	Observational
Source	Cardiovascular Institute of the South Clinical Research Corporation
Contact	Sarah Melvin, MSPH
Phone	2489159906
Email	sarah.melvin@cardio.com
Status	Recruiting
Phase
Start date	December 7, 2020
Completion date	December 7, 2022

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