Who is sponsoring NCT04253171?

NCT04253171 is sponsored by Herlev and Gentofte Hospital.

What drugs are being tested in NCT04253171?

Interventions in NCT04253171: Lithoplasty, Conventional.

What condition does NCT04253171 study?

NCT04253171 studies Percutaneous Coronary Intervention, Coronary Artery Calcification, Coronary Artery Disease.

Is NCT04253171 still recruiting?

NCT04253171 is currently completed. Last updated 5 November 2025.

Last reviewed 2025-11-05 · How we verify

NCT04253171: BALI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions

Completed NA Last updated 5 November 2025

What this trial tests

NA trial testing Lithoplasty in Percutaneous Coronary Intervention in 200 participants. Completed in 1 November 2025.

Timeline

29 January 2020

Primary endpoint
1 September 2024

1 November 2025

Quick facts

Lead sponsor	Herlev and Gentofte Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	200
Start date	29 January 2020
Primary completion	1 September 2024
Estimated completion	1 November 2025
Sites	9 locations across Belgium, Denmark, Estonia, Norway

Drugs / interventions tested

Lithoplasty
Conventional

Conditions studied

Percutaneous Coronary Intervention — all drugs for Percutaneous Coronary Intervention →
Coronary Artery Calcification — all drugs for Coronary Artery Calcification →
Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Herlev and Gentofte Hospital

Who can join

Adults 18 to 90, any sex, with Percutaneous Coronary Intervention or Coronary Artery Calcification. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Severely calcified coronary stenoses are difficult to treat with percutaneous coronary intervention (PCI) using current techniques and there is little specific evidence on how to best treat these cases. It is hypothesized that balloon lithoplasty is superior to conventional balloons for lesion preparation of severely calcified coronary lesions before stent implantation in terms of procedural failure and 1-year target vessel failure.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions.
Riley RF, Patel MP, Abbott JD, Bangalore S, et al · · 2024 · cited 58× · PMID 39132214 · DOI 10.1016/j.jscai.2023.101259
Impact of coronary calcium morphology on intravascular lithotripsy.
McInerney A, Travieso A, Jerónimo Baza A, Alfonso F, et al · · 2024 · cited 17× · PMID 38776142 · DOI 10.4244/eij-d-23-00605
Can Most Calcified Coronary Stenosis Be Optimized With Coronary Intravascular Lithotripsy?
Mody R, Dash D, Mody B, Maligireddy AR, et al · · 2023 · cited 10× · PMID 37181385 · DOI 10.1016/j.jacasi.2022.11.016
Balloon Lithotripsy Added to Conventional Preparation Before Stent Implantation in Severely Calcified Coronary Lesions.
Kristensen AT, Christiansen EH, Holm NR, Kelbæk H, et al · · 2026 · cited 1× · PMID 41400597 · DOI 10.1016/j.jcin.2025.09.028

Verify or expand the search:

Other recruiting trials for Percutaneous Coronary Intervention

Currently open trials in the same condition.

NCT07231939 — Use of Flozins (Empagliflozin/Dapagliflozin) for Prevention of AKI · recruiting
NCT07378163 — Study on the Preferences for PCI Implantation Devices Among Doctors and Patients · recruiting
NCT07378137 — Comparing the Components of Composite Endpoints for Healthcare Providers and Patients · recruiting
NCT06878729 — Antegrade Dissection and Re-entry Versus Retrograde Strategy in CTO PCI · NA · recruiting
NCT07446023 — IVUS-FFR Accuracy for Coronary Stenosis · NA · recruiting

Other Herlev and Gentofte Hospital trials

Trials by the same sponsor.

NCT07493590 — CAPTURE-HFpEF: National Study of Identification and Phenotyping of Heart Failure With Preserved Ejection Fraction · not yet recruiting
NCT07321964 — The Effect of a Digital MediYoga Program on Quality of Life, Blood Pressure and Heart Rate Among Patients With Atrial Fi · NA · recruiting
NCT06706661 — Implementation of Nutritional Efforts on Discharged Older Patients · NA · recruiting
NCT06618417 — Evaluating the Impact of Home-Based Sleep Apnea Diagnostic on Well-Being, Health Behavior, and AF Load in Patients with · NA · recruiting
NCT06642272 — A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Hea · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04253171 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Herlev and Gentofte Hospital
Last refreshed: 5 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04253171.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing