Comparison of Coronary Lithoplasty and Rotablation

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Calcified Atheroma
• Intervention / Treatment: Procedure: Rotablation; Procedure: Coronary Lithoplasty

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Gießen, Germany, 35392
    • University of Gießen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rotablation	Procedure: Rotablation; Percutaneous Coronary Intervention using Rotablation
Experimental: Coronary Lithoplasty	Procedure: Coronary Lithoplasty; Percutaneous Coronary Intervention using Lithoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Minimal Stent Area (End of the Procedure)	0 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Giessen
• Collaborators: Else Kröner-Fresenius Stiftung, Bad Homburg, Germany
• Investigators: Principal Investigator: Florian Blachutzik, Dr., University of Gießen

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2019
• Primary Completion (Actual): June 28, 2021
• Study Completion (Actual): June 28, 2022

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Percutaneous coronary intervention; Rotablation; Coronary lithoplasty
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Coronary Disease; Coronary Artery Disease; Plaque, Atherosclerotic
• Other Study ID Numbers: ROTA.shock

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No