Status:
COMPLETED
Comparison of Coronary Lithoplasty and Rotablation
Lead Sponsor:
University of Giessen
Collaborating Sponsors:
Else Kröner-Fresenius Stiftung, Bad Homburg, Germany
Conditions:
Coronary Artery Disease
Calcified Atheroma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04047368
Start Date
June 28 2019
End Date
June 28 2022
Last Update
December 1 2023
Active Locations (1)
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1
University of Giessen
Giessen, Germany, 35392