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

NCT04181268 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-03-01

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Percutaneous coronary Intervention

Calcified plaque modification during percutaneous coronary intervention

Sponsors & Collaborators

  • Hospital Universitario La Paz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-15
Primary Completion
2023-11-30
Completion
2023-11-30
FDA Device
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04181268 on ClinicalTrials.gov