Skip to main content
OpenTrials
Completed

NCT Number: NCT04298307

Registry of Coronary Lithotripsy in Spain.

The REPLICA TRIAL tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Diseases Arterial Occlusive Diseases Arteriosclerosis Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Germans Trias I Pujol, Badalona, Barcelona, Spain

Loading trial locations.

About this study

The REPLICA TRIAL tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 18 years of age.
  • Patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation who, at the operator's discretion and according to the hospital routine clinical practice, require an ICL with the Shockwave catheter.
  • The patients have been informed of the study characteristics and have given their written informed consent.

Exclusion criteria

  • Refusal to participate in this study.
  • Patients whose life expectancy is < 1 year.
  • Patients with hemodynamic instability with Killip class III or IV.

Treatment and study plan

Intracoronary lithotripsy (ICL)

Other

ICL using the Shockwave catheter.

Primary outcomes

  1. Procedural success

    Time frame: Index Procedure

    Assessment of procedural success defined as angiographic results (TIMI grade 3 and residual stenosis < 20% without in-hospital complications ).

Secondary outcomes

  1. MACE

    Time frame: Index Procedure

    Major Cardiovascular Adverse Events (MACE), defined as a composite of cardiac death, target vessel related nonfatal infarction or need for unplanned target vessel revascularization during hospital admission.

  2. MACE

    Time frame: 12 months

    Major Cardiovascular Adverse Events (MACE), defined as a composite of cardiac death, target vessel related nonfatal infarction or need for unplanned target vessel revascularization.

  3. Residual stenosis

    Time frame: Index Procedure

    Assessment of angiographic stenosis during stent implantation

  4. Death (all cause)

    Time frame: 12 months

    Death (all cause)

  5. Death (cardiovascular)

    Time frame: 12 months

    Death (cardiovascular)

  6. Non-fatal Myocardial Infarction

    Time frame: 12 months

    Non-fatal Myocardial Infarction

  7. Target Vessel Revascularization

    Time frame: 12 months

    Target Vessel Revascularization

  8. Stent thrombosis of target lesion

    Time frame: 12 months

    Stent thrombosis of target lesion

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study title

Prospective, Multicenter, Observational, Single-arm Registry of Coronary Lithotripsy for the Management of Calcified Lesions in Spain.

Acronym: REPLICA

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2020
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.