Clinical trial NCT04047368: Comparison of Coronary Lithoplasty and Rotablation
Official title: Comparison of Coronary Lithoplasty and Rotablation for the Interventional Treatment of Severely Calcified Coronary Stenoses - ROTA.Shock-Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Calcified Atheroma
Keywords: Percutaneous coronary intervention
Rotablation
Coronary lithoplasty
Optical coherence tomography
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Else Kröner-Fresenius Stiftung, Bad Homburg, Germany
First posted: 2019-08-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Minimal Stent Area (End of the Procedure)
timeFrame: 0 days
Secondary outcomes:
measure: Minimal/Mean/Maximal Stent Diameter
timeFrame: 0 days
measure: Minimal/Mean/Maximal Lumen area
timeFrame: 0 days
measure: Minimal/Mean/Maximal Lumen diameter
timeFrame: 0 days
measure: Mean/Maximal Stent area
timeFrame: 0 days
measure: Incidence of target lesion failure
timeFrame: 0 months; 1 month; 6 months
measure: Incidence of target vessel failure
timeFrame: 0 months; 1 month; 6 months
measure: MACE rate
timeFrame: 0 months; 1 month; 6 months
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University of Giessen
Study officials:
affiliation: University of Giessen
name: Florian Blachutzik, Dr.
role: PRINCIPAL_INVESTIGATOR
References: