ROtational Atherectomy Lithotripsy or LasER for the Treatment of CAlcified STEnosis

  • STATUS
    Recruiting
  • End date
    Nov 12, 2023
  • participants needed
    150
  • sponsor
    Hospital Universitario La Paz
Updated on 12 March 2021

Summary

Some data exist about the efficacy and safety of rotational atherectomy, intravascular lithotripsy and excimer laser to modify calcified plaques.

However there is no direct randomized comparison between these three tools in this scenario.

The aim of this pilot randomized trial is to compare the safety and efficacy of these three techniques during PCI of moderate to severe calcified lesions.

Description

Some data exist about the efficacy and safety of rotational atherectomy, intravascular lithotripsy and excimer laser to modify calcified plaques.

However there is no direct randomized comparison between these three tools in this scenario.

The aim of this pilot randomized trial is to compare the safety and efficacy of these three techniques during PCI of moderate to severe calcified lesions.

The primary endpoint will be the percentage of stent expansion measured with optical coherence tomography. Between secondary endpoints we will analyze the strategy success (defined as successful stent delivery and expansion with <20% residual stenosis and TIMI 3 flow without crossover or stent failure) and presentation of clinical adverse at 1 year follow-up .

Details
Condition Coronary Artery Disease, Coronary Artery Disease, Coronary heart disease, Cardiac Ischemia, Myocardial Ischemia
Treatment Percutaneous coronary intervention
Clinical Study IdentifierNCT04181268
SponsorHospital Universitario La Paz
Last Modified on12 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients >18 years
Stenosis 70% in a coronary artery with a diameter 2,5 y 4 mm
Moderate to severe angiographic calcification
Stable coronary artery disease or NSTEMI
Native coronary vessel or bypass graft

Exclusion Criteria

Knwon allergies to aspirin or P2y12 inhibitors
STEMI
Cardiogenic shock at the time of PCI
Treated lesion in a bifurcation with side branch diameter > 2mm
Absence of informed consent
Impossibility for 1year follow up
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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