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Trial record 5 of 9 for:    lithoplasty

Comparison of Coronary Lithoplasty and Rotablation

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ClinicalTrials.gov Identifier: NCT04047368
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Else Kröner-Fresenius Stiftung, Bad Homburg, Germany
Information provided by (Responsible Party):
University of Giessen

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Calcified Atheroma Procedure: Rotablation Procedure: Coronary Lithoplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Coronary Lithoplasty and Rotablation for the Interventional Treatment of Severely Calcified Coronary Stenoses - ROTA.Shock-Trial
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : June 28, 2021
Estimated Study Completion Date : June 28, 2022

Arm Intervention/treatment
Active Comparator: Rotablation Procedure: Rotablation
Percutaneous Coronary Intervention using Rotablation

Experimental: Coronary Lithoplasty Procedure: Coronary Lithoplasty
Percutaneous Coronary Intervention using Lithoplasty




Primary Outcome Measures :
  1. Minimal Stent Area (End of the Procedure) [ Time Frame: 0 days ]

Secondary Outcome Measures :
  1. Minimal/Mean/Maximal Stent Diameter [ Time Frame: 0 days ]
  2. Minimal/Mean/Maximal Lumen area [ Time Frame: 0 days ]
  3. Minimal/Mean/Maximal Lumen diameter [ Time Frame: 0 days ]
  4. Mean/Maximal Stent area [ Time Frame: 0 days ]
  5. Incidence of target lesion failure [ Time Frame: 0 months; 1 month; 6 months ]
  6. Incidence of target vessel failure [ Time Frame: 0 months; 1 month; 6 months ]
  7. MACE rate [ Time Frame: 0 months; 1 month; 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047368


Contacts
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Contact: Florian Blachutzik, Dr. +49 641 985 42212 florian.blachutzik@innere.med.uni-giessen.de

Locations
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Germany
University of Giessen Recruiting
Gießen, Germany, 35392
Contact: Florian Blachutzik, Dr.         
Sponsors and Collaborators
University of Giessen
Else Kröner-Fresenius Stiftung, Bad Homburg, Germany
Investigators
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Principal Investigator: Florian Blachutzik, Dr. University of Giessen

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Responsible Party: University of Giessen
ClinicalTrials.gov Identifier: NCT04047368     History of Changes
Other Study ID Numbers: ROTA.shock
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Giessen:
Percutaneous coronary intervention
Rotablation
Coronary lithoplasty
Optical coherence tomography
Additional relevant MeSH terms:
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Coronary Artery Disease
Plaque, Atherosclerotic
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical