Calcified Atheroma, Coronary Artery Disease
Conditions
Keywords
Percutaneous coronary intervention, Rotablation, Coronary lithoplasty, Optical coherence tomography
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.
Interventions
PROCEDURERotablation
Percutaneous Coronary Intervention using Rotablation
PROCEDURECoronary Lithoplasty
Percutaneous Coronary Intervention using Lithoplasty
Sponsors
Else Kröner-Fresenius Stiftung, Bad Homburg, Germany
University of Giessen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal Stent Area (End of the Procedure) | 0 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Mean/Maximal Stent area | 0 days |
| Minimal/Mean/Maximal Lumen area | 0 days |
| Minimal/Mean/Maximal Lumen diameter | 0 days |
| Minimal/Mean/Maximal Stent Diameter | 0 days |
Countries
Germany
Outcome results
None listed