NCT04428177

Brief Summary

The aim of this prospective randomised study is to compare the safety and efficacy of novel intravascular lithotripsy (IVL) to the standard therapy of calcified coronary lesions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

June 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

2.6 years

First QC Date

June 2, 2020

Last Update Submit

September 8, 2023

Conditions

Coronary Artery Calcification

Keywords

Coronary Artery CalcificationIntravascular Lithotripsy

Outcome Measures

Primary Outcomes (2)

  • Minimal lumen diamether (MLD)

    minimal diamether of treated lesion measured by quantitative coronary angiography

    1 year

  • Late luemn loss (LLL)

    difference between post-procedure MLD and 12-month MLD

    1 year

Secondary Outcomes (2)

  • Binary in-stent restenosis

    1 year

  • Major adverse cardiac events (MACE)

    1 year

Other Outcomes (2)

  • Angiographic success

    up to end of the procedure, an average of 2 hours

  • Clinical success

    up to discharge, an average of 3 days

Study Arms (2)

Intrvascular Lithotripsy

EXPERIMENTAL

Calcified coronary lesions will be treated with intrvascular lithotripsy

Device: Intravascular lithotripsy

Standard therapy

ACTIVE COMPARATOR

Standard treatment of calcified coronary lesions: cutting, scoring or non-compliant balloon predilatation or rotational atherectomy

Device: Standart therapy

Interventions

Intravascular lithotripsyDEVICE

Intravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel

Intrvascular Lithotripsy
Standart therapyDEVICE

conventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy

Standard therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Informed, written consent by the patient
  • Ability to comply fully with the study protocol
  • Negative pregnancy test (and effective contraception) in women with childbearing potential
  • Native coronary artery lesion with diameter stenosis ≥50% suitable for PCI
  • Heavy calcification, defined as calcification within the lesion on both sides of the vessel assessed during angiography
  • Reference vessel diameter (RVD) ≥2.5 mm with lesion length \<32 mm
  • TIMI flow 3 of the target vessel at baseline
  • No visible thrombus at target lesion site

You may not qualify if:

  • Cardiogenic shock or haemodynamic instability requiring mechanical circulatory support
  • Active malignancy or other comorbidities with a life expectancy of 12 months
  • Limited the possibility of control coronaro angiography (e.g., advanced renal failure)
  • Known allergy to contrast agents (that cannot be adequately premedicated) or required concomitant dual antiplatelet therapy
  • Current problems with substance abuse (e.g., alcohol or drugs)
  • Subject is participating in another investigational drug or device clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiovascular Diseases, University Hospital

Ostrava, Česká Republika, 70852, Czechia

RECRUITING

Related Publications (1)

  • Pleva L, Kukla P, Konde A. Comparison of the efficacy of intravascular lithotripsy and rotational atherectomy as adjunctive therapy before drug-eluting stent implantation in calcified coronary lesions (CCS- Coronary Calcification Study). BMC Cardiovasc Disord. 2025 Sep 2;25(1):648. doi: 10.1186/s12872-025-05082-z.

    PMID: 40898049DERIVED

Central Study Contacts

Leos Pleva, MD,PhD.

CONTACT

+420733414740leos.pleva@volny.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 11, 2020

Study Start

June 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)