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 Details — Status: Completed

Administrative data

• NCT number: NCT04047368
• Other study ID #: ROTA.shock
• Status: Completed
• Phase: N/A
• Start date: June 28, 2019
• Est. completion date: June 28, 2022

Study information

• Verified date: November 2023
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 28, 2022
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age>18 yrs
• Stable coronary heart disease or acute coronary syndromes
• Single or multi vessel disease. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
• Written informed consent was obtained before the procedure
• Severely calcified coronary lesion with indication for rotablation

Exclusion Criteria:

• Known renal insufficiency (serum creatinine clearance <30ml/min/1.73m² or receiving dialysis)
• Known allergy against protocol-required medications including ASS, prasugrel, ticagrelor, clopidogrel, heparin. History of bleeding diathesis or known coagulopathy
• Cardiogenic shock
• Lesion length > 32mm
• Bifurcation lesions requiring 2-Stent-Strategies

Related Conditions & MeSH terms

• Calcified Atheroma
• Coronary Artery Disease
• Plaque, Atherosclerotic

Intervention

Procedure:
• Rotablation
Percutaneous Coronary Intervention using Rotablation
• Coronary Lithoplasty
Percutaneous Coronary Intervention using Lithoplasty

Locations

Country	Name	City	State
Germany	University of Giessen	Gießen

Sponsors (2)

Lead Sponsor	Collaborator
University of Giessen	Else Kröner-Fresenius Stiftung, Bad Homburg, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimal Stent Area (End of the Procedure)		0 days
Secondary	Minimal/Mean/Maximal Stent Diameter		0 days
Secondary	Minimal/Mean/Maximal Lumen area		0 days
Secondary	Minimal/Mean/Maximal Lumen diameter		0 days
Secondary	Mean/Maximal Stent area		0 days
Secondary	Incidence of target lesion failure		0 months; 1 month; 6 months
Secondary	Incidence of target vessel failure		0 months; 1 month; 6 months
Secondary	MACE rate		0 months; 1 month; 6 months