NCT06369142

Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy: A Randomized, Multicenter Study About the Additional Benefit of Coronary Lithotripsy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 666 (estimated)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Intravascular lithotripsy (IVL)	Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm
DEVICE	Standard non-IVL methods	Standard non-IVL methods treating severely calcified lesions such as special high, super high and cutting balloons and ablative procedures

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-04-30
• Completion: 2027-07-31
• First posted: 2024-04-16
• Last updated: 2026-01-06

Locations

22 sites across 1 country: Germany