NCT05147363

Shockwave: Disruption for A Better Fit

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Cardiovascular Institute of the South Clinical Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2020-12-07
• Primary completion: 2022-06-07
• Completion: 2022-12-07
• First posted: 2021-12-07
• Last updated: 2021-12-07

Locations

1 site across 1 country: United States