Comparison of Coronary Lithoplasty and Rotablation

University of Giessen

Status: Completed

Conditions: Coronary Artery Disease; Calcified Atheroma

Treatments: Procedure: Rotablation; Procedure: Coronary Lithoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04047368

ROTA.shock

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

Rotablation

Active Comparator group

Treatment:

Procedure: Rotablation

Coronary Lithoplasty

Experimental group

Treatment:

Procedure: Coronary Lithoplasty