NCT05016726

Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions

Intravascular Lithotripsy and/or Mechanical Debulking Multicenter Registry for the Treatment of Complex Calcified Coronary Arteries: the ROLLING-STONE.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: SS Annunziata Hospital, Savigliano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate intra-procedural and long-term effects of intravascular lithotripsy with the ShockWave System and/or non-balloon mechanical debulking devices, prior and/or after coronary stenting in an angiographically well-defined group of patients with complex calcified coronary artery lesions.

Detailed description

At present age, there are few real-world data published about the use of intravascular lithotripsy. Its safety and possible procedural complications remain unclear, and the effects of combination with other plaque-modification devices are unknown. Finally, there are few data about long-term outcomes in the real-life setting. Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with Stable CAD or Acute Coronary Syndromes, that are suitable for percutaneous coronary intervention (PCI). Approximately 400 subjects at 20 sites will be enrolled. Subjects will be followed through discharge, 30 days, 6 and 12 months

Conditions

• Coronary Artery Disease
• Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Intravascular Lithotripsy	Intravascular Lithotripsy and/or Rotational Atherectomy and/or Orbital Atherectomy to the target vessel prior to placing a coronary stent.

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-10-01
• Completion: 2024-10-30
• First posted: 2021-08-23
• Last updated: 2021-08-23

Regulatory

• FDA-regulated device study