NCT04181268

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Percutaneous coronary Intervention	Calcified plaque modification during percutaneous coronary intervention

Timeline

• Start date: 2020-11-15
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2019-11-29
• Last updated: 2021-03-01

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study