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

Hospital Universitario La Paz150 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Coronary Artery Disease

Interventions

Percutaneous coronary InterventionDEVICE

Calcified plaque modification during percutaneous coronary intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

La Paz University Hospital

Madrid, Spain

RECRUITING

Outcomes

Primary Outcomes

Percentage of stent expansion by optical coherence tomography

We will analyze with optical coherence tomography the percentage of stent expansion (defined as the minimal stent area divided by the mean of the proximal and distal reference lumen areas).

Time frame: At the end of percutaneous coronary intervention

Secondary Outcomes

Strategy success rate

Successful stent delivery and expansion with \<20% residual stenosis and TIMI3 flow without crossover or stent failure. Successful stent delivery and expansion with \<20% residual stenosis and TIMI3 flow without crossover or stent failure. Successful stent delivery and expansion with residual stenosis \<20% and TIMI 3 without crossover

Time frame: At the end of percutaneous coronary intervention

Data from ClinicalTrials.gov

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