Comparison of Coronary Lithoplasty and Rotablation

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Calcified Atheroma
• Interventions: Procedure: Rotablation; Procedure: Coronary Lithoplasty

• Registration Number: NCT04047368
• Lead Sponsor: University of Giessen

Brief 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.

Study Timeline

• Study Start: 2019-06-28
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-06
• Primary Completion: 2021-06-28
• Study Completion: 2022-06-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotablation	Rotablation	-
Coronary Lithoplasty	Coronary Lithoplasty	-

Primary Outcome Measures

Name	Time	Method
Minimal Stent Area (End of the Procedure)	0 days

Secondary Outcome Measures

Name	Time	Method
Minimal/Mean/Maximal Lumen diameter	0 days
Incidence of target vessel failure	0 months; 1 month; 6 months
Incidence of target lesion failure	0 months; 1 month; 6 months
MACE rate	0 months; 1 month; 6 months
Minimal/Mean/Maximal Stent Diameter	0 days
Minimal/Mean/Maximal Lumen area	0 days
Mean/Maximal Stent area	0 days

Trial Locations

Locations (1)

University of Giessen; 🇩🇪 Gießen, Germany