Comparison of Coronary Lithoplasty and Rotablation
Primary Purpose
Coronary Artery Disease, Calcified Atheroma
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Rotablation
Coronary Lithoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous coronary intervention, Rotablation, Coronary lithoplasty, Optical coherence tomography
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
Sites / Locations
- University of GiessenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Rotablation
Coronary Lithoplasty
Arm Description
Outcomes
Primary Outcome Measures
Minimal Stent Area (End of the Procedure)
Secondary Outcome Measures
Minimal/Mean/Maximal Stent Diameter
Minimal/Mean/Maximal Lumen area
Minimal/Mean/Maximal Lumen diameter
Mean/Maximal Stent area
Incidence of target lesion failure
Incidence of target vessel failure
MACE rate
Full Information
NCT ID
NCT04047368
First Posted
July 22, 2019
Last Updated
November 12, 2021
Sponsor
University of Giessen
Collaborators
Else Kröner-Fresenius Stiftung, Bad Homburg, Germany
1. Study Identification
Unique Protocol Identification Number
NCT04047368
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2019 (Actual)
Primary Completion Date
June 28, 2021 (Actual)
Study Completion Date
June 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Giessen
Collaborators
Else Kröner-Fresenius Stiftung, Bad Homburg, Germany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Calcified Atheroma
Keywords
Percutaneous coronary intervention, Rotablation, Coronary lithoplasty, Optical coherence tomography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rotablation
Arm Type
Active Comparator
Arm Title
Coronary Lithoplasty
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Rotablation
Intervention Description
Percutaneous Coronary Intervention using Rotablation
Intervention Type
Procedure
Intervention Name(s)
Coronary Lithoplasty
Intervention Description
Percutaneous Coronary Intervention using Lithoplasty
Primary Outcome Measure Information:
Title
Minimal Stent Area (End of the Procedure)
Time Frame
0 days
Secondary Outcome Measure Information:
Title
Minimal/Mean/Maximal Stent Diameter
Time Frame
0 days
Title
Minimal/Mean/Maximal Lumen area
Time Frame
0 days
Title
Minimal/Mean/Maximal Lumen diameter
Time Frame
0 days
Title
Mean/Maximal Stent area
Time Frame
0 days
Title
Incidence of target lesion failure
Time Frame
0 months; 1 month; 6 months
Title
Incidence of target vessel failure
Time Frame
0 months; 1 month; 6 months
Title
MACE rate
Time Frame
0 months; 1 month; 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florian Blachutzik, Dr.
Phone
+49 641 985 42212
Email
florian.blachutzik@innere.med.uni-giessen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Blachutzik, Dr.
Organizational Affiliation
University of Giessen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Giessen
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Blachutzik, Dr.
12. IPD Sharing Statement
Learn more about this trial
Comparison of Coronary Lithoplasty and Rotablation
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