ROtational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified STEnosis

Roller Coaster Trial: Rotational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified

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.

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 .

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.