Last reviewed · How we verify
NCT03118895
Leaders Free III: BioFreedom™ Clinical Trial
NA trial testing BioFreedom™ BA9™ drug-coated stent in Cardiac Death in 404 participants. Completed in 18 November 2022.
5 September 2019
Quick facts
| Lead sponsor | Biosensors Europe SA |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 404 |
| Start date | 8 November 2017 |
| Primary completion | 5 September 2019 |
| Estimated completion | 18 November 2022 |
| Sites | 2 locations across France, Switzerland |
Drugs / interventions tested
- BioFreedom™ BA9™ drug-coated stent
Conditions studied
- Cardiac Death — all drugs for Cardiac Death →
- Myocardial Infarction — all drugs for Myocardial Infarction →
- Stent Thrombosis — all drugs for Stent Thrombosis →
- Bleeding — all drugs for Bleeding →
Sponsor
Biosensors Europe SA — full company profile →
Who can join
75 and older, any sex, with Cardiac Death or Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Polymer-free Biolimus-A9 coated thin strut stents for patients at high bleeding risk 1-year results from the LEADERS FREE III study.
Eberli FR, Stoll HP, Urban P, Morice MC, et al · · 2022 · cited 8× · PMID 34241947 · DOI 10.1002/ccd.29869 -
Clinical outcomes with thin versus thick strut polymer-free biolimus-coated stents at 3 years.
Eberli FR, Oldroyd KG, Urban P, Krucoff MW, et al · · 2024 · cited 1× · PMID 38890129 · DOI 10.1136/openhrt-2024-002679
Verify or expand the search:
- PubMed search for NCT03118895
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BioFreedom™ BA9™ drug-coated stent
Trials testing the same drug.
- NCT03365492 — BioFreedom Pharmacokinetic Study · NA · completed
Other recruiting trials for Cardiac Death
Currently open trials in the same condition.
- NCT05778981 — Endothelial Dysfunction and Non-cardiac Surgery · recruiting
- NCT03892265 — A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti · active not recruiting
Other Biosensors Europe SA trials
Trials by the same sponsor.
- NCT05643430 — ULTRA LONG: BioFreedom Ultra · NA · active not recruiting
- NCT05799963 — ALPHA LONG Study- BioMatrix AlphaTM Stent Study in Patients With CAD · NA · active not recruiting
- NCT05505929 — eUltra 10k - Biofreedom Ultra · recruiting
- NCT04966273 — Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO · NA · completed
- NCT04796038 — Rise Semi Compliant Balloon Study in Patient With CAD · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03118895 (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 Biosensors Europe SA
- Last refreshed: 29 February 2024
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/NCT03118895.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing