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

Coronary Artery Disease Clinical Trial

— ROLLERCOASTR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04181268
• Other study ID #: 0001
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2020
• Est. completion date: November 2023

Study information

• Verified date: February 2021
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Percutaneous coronary Intervention
Calcified plaque modification during percutaneous coronary intervention

Locations

Country	Name	City	State
Spain	La Paz University Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At the end of percutaneous coronary intervention
Secondary	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	At the end of percutaneous coronary intervention