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Completed

NCT Number: NCT04047368

Comparison of Coronary Lithoplasty and Rotablation

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Giessen

Giessen, 35392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotablation

Procedure

Percutaneous Coronary Intervention using Rotablation

Coronary Lithoplasty

Procedure

Percutaneous Coronary Intervention using Lithoplasty

Primary outcomes

  1. Minimal Stent Area (End of the Procedure)

    Time frame: 0 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Collaborators

  • Else Kröner Fresenius Foundation

Registry information

Official study title

Comparison of Coronary Lithoplasty and Rotablation for the Interventional Treatment of Severely Calcified Coronary Stenoses - ROTA.Shock-Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 6, 2019
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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