Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT04181268
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 .
Study:
NCT04181268
Study Brief:
Protocol Section:
NCT04181268