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NCT03365492
BioFreedom Pharmacokinetic Study
NA trial testing BioFreedom™ BA9™ drug-coated stent in Coronary Artery Disease in 17 participants. Completed in 30 June 2018.
30 April 2018
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 | 17 |
| Start date | 12 March 2018 |
| Primary completion | 30 April 2018 |
| Estimated completion | 30 June 2018 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- BioFreedom™ BA9™ drug-coated stent
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Myocardial Infarction — all drugs for Myocardial Infarction →
Sponsor
Biosensors Europe SA — full company profile →
Who can join
18 and older, any sex, with Coronary Artery Disease or Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this pharmacokinetic (PK) study is to characterize the maximum concentration (Cmax) and time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus in a cohort of coronary artery disease (CAD) patients following implantation of BioFreedomTM SS stent.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03365492
- 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.
- NCT03118895 — Leaders Free III: BioFreedom™ Clinical Trial · NA · completed
Other recruiting trials for Coronary Artery Disease
Currently open trials in the same condition.
- NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
- NCT07420582 — Antegrade Autologous Blood Reinfusion After CPB · recruiting
- NCT07493603 — A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease · Phase 1, PHASE2 · recruiting
- NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
- NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · 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 NCT03365492 (US National Library of Medicine, public domain)
- 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: 1 July 2020
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/NCT03365492.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing