Coronary Artery Disease
Conditions
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 .
Interventions
DEVICEPercutaneous coronary Intervention
Calcified plaque modification during percutaneous coronary intervention
Sponsors
Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of stent expansion by optical coherence tomography | 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
| Measure | Time frame | Description |
|---|---|---|
| Strategy success rate | At the end of percutaneous coronary intervention | 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 |
Countries
Spain
Outcome results
None listed