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Comparison of Coronary Lithoplasty and Rotablation

Coronary Artery Disease Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04047368
Study type Interventional
Source University of Giessen
Contact
Status Completed
Phase N/A
Start date June 28, 2019
Completion date June 28, 2022
View Details
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