NCT07348341

Brief Summary

This study is a prospective, investigator-initiated, multi-center, single arm, observational registry of performance of Excimer Laser Coronary Atherectomy (ELCA) in standard use cases of percutaneous coronary intervention (PCI).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
38mo left

Started Apr 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Jul 2029

First Submitted

Initial submission to the registry

November 17, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2029

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

November 17, 2025

Last Update Submit

January 8, 2026

Conditions

Acute Coronary SyndromesStable Coronary Artery Disease

Keywords

excimer laser coronary atherectomyELCACLARITcoronary artery diseaseacute coronary syndromes

Outcome Measures

Primary Outcomes (2)

  • Procedural success during index PCI

    The primary endpoint of efficacy is procedural Success during index PCI:, which is a combined endpoint of these following events: * Angiographic success defined as residual stenosis \<30% in two orthogonal projections after lesion treatment with ELCA destination therapy with DES or DCB * TIMI 3 flow and absence of ELCA related complications during the procedure * Intra-Coronary Imaging success defined as final MSA \> 5.5mm2 IVUS or 4.5mm2 OCT with \> 80% stent expansion - site reported

    During Procedure

  • Freedom from in hospital Major Adverse Cardiovascular Events

    The primary endpoint of safety is freedom from in-hospital Major Adverse Cardiovascular Events (MACE), including : cardiac death, target vessel myocardial infarction (TVMI), urgent repeat target vessel revascularization (TVR) with either PCI or CABG, and Stroke.

    Periprocedural

Secondary Outcomes (30)

  • Composite endpoint of one of events reported

    30 days and 1 year

  • Success of revascularization: Freedom from Target lesion failure (TLF) events and ICI assessed stent optimization

    30 days and 1 year

  • Procedural Characteristic- Cost

    During procedure

  • Procedural Characteristic- Device success based on maximum fluence

    During procedure

  • Procedural Characteristic- Fluoroscopy Time

    During procedure

  • +25 more secondary outcomes

Interventions

Excimer Laser Coronary Atherectomy (ELCA)DEVICE

ELCA treat a significant coronary stenosis or recanalize occluded coronary arteries using UV during percutaneous coronary intervention.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stable coronary artery disease or acute coronary syndromes who will be treated with excimer laser coronary atherectomy (ELCA)

You may qualify if:

  • Subjects will be included if all the following criteria are met:
  • Age 18 years or over
  • Patient willing to be included in the registry
  • Patients with stable coronary artery disease or acute coronary syndromes with de-novo or intra-stent restenosis (ISR) coronary lesions suitable to be treated with ELCA
  • Non-Crossable with ICI catheter or:
  • Crossable with ICI catheter with significant calcium score suggesting need for calcium modification based on IVUS or OCT criteria and/or
  • Non-Dilatable with 1:1 NC balloon
  • Mandated use of ICI:
  • Attempted before use of ELCA or
  • Following ELCA and any other calcium modification strategy utilized (to evaluate whether the additional modification demonstrates significant additional modification of the calcium on ICI)
  • Final after DES implantation or prior to use of DCB
  • Declared PCI strategy (planned use of ELCA, need for IVL/specialty balloons/alternative atherectomy and stent strategy) prior to PCI procedure

You may not qualify if:

  • Pregnant or breast feeding
  • Unable to give informed consent
  • PCI performed without IVCI attempt
  • No ELCA use
  • Allergy to clopidogrel, prasugrel or ticagrelor or non-compliance
  • Post- cardiac arrest or haemodynamic instability
  • Participation in another trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Coronary SyndromeCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Peter O'kane, Professor

    Dorset Heart Centre, The Royal Bournemouth Hospital

    STUDY CHAIR

Central Study Contacts

Julie FAURE

CONTACT

+33 (0)675574485jfaure@cerc-europe.org

Phani Kondamudi

CONTACT

+33 (0)6 60 05 55 12pkondamudi@cerc-europe.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

January 16, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

July 30, 2028

Study Completion (Estimated)

July 30, 2029

Last Updated

January 16, 2026

Record last verified: 2026-01