Roller Coaster Trial: Rotational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Hospital Universitario La Paz
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Percentage of stent expansion by optical coherence tomography
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed 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 .
Investigators
Alfonso Jurado, MD, PhD
Principal Investigator
Hospital Universitario La Paz
Eligibility Criteria
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.
- •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.
Outcomes
Primary Outcomes
Percentage of stent expansion by optical coherence tomography
Time Frame: At the end of percutaneous coronary intervention
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).
Secondary Outcomes
- Strategy success rate(At the end of percutaneous coronary intervention)