NCT04047368

Comparison of Coronary Lithoplasty and Rotablation

Comparison of Coronary Lithoplasty and Rotablation for the Interventional Treatment of Severely Calcified Coronary Stenoses - ROTA.Shock-Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares a new method of treating severely calcified coronary lesions, the intracoronary lithoplasty, with the current gold standard, the rotablation.

Detailed description

Severe coronary calcification is still a challenge for percutaneous coronary intervention (PCI). Reduction of the calcified plaque mass is necessary to achieve adequate stent expansion during further course. Rotablation has been the only reliable option to treat extremely calcified coronary lesions for a long time. Coronary lithoplasty has been recently introduced as a new promising treatment option in this special subset. It provides the unique opportunity to break severely calcified plaque structures even inside deeper layers of the vessel wall. Aim of this study is to compare rotablation and coronary lithotripsy for treatment of severely calcified coronary lesions. Plaque structure, plaque volume, as well as lumen diameters will be analyzed by optical coherence tomography (OCT) before and after debulking, as well as after stent implantation.

Conditions

• Coronary Artery Disease
• Calcified Atheroma

Interventions

Type	Name	Description
PROCEDURE	Rotablation	Percutaneous Coronary Intervention using Rotablation
PROCEDURE	Coronary Lithoplasty	Percutaneous Coronary Intervention using Lithoplasty

Timeline

• Start date: 2019-06-28
• Primary completion: 2021-06-28
• Completion: 2022-06-28
• First posted: 2019-08-06
• Last updated: 2023-12-01

Locations

1 site across 1 country: Germany