NCT04250909 is a clinical trial of Passeo-18 in Overall Mortality, sponsored by Biotronik AG.

Who is sponsoring NCT04250909?

NCT04250909 is sponsored by Biotronik AG.

What drugs are being tested in NCT04250909?

Interventions in NCT04250909: Passeo-18, Passeo-18 Lux.

What condition does NCT04250909 study?

NCT04250909 studies Overall Mortality.

Is NCT04250909 still recruiting?

NCT04250909 is currently completed. Last updated 5 August 2021.

Last reviewed 2021-08-05 · How we verify

NCT04250909

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

Retrospective Follow-up of BIOLUX P-I/-II

Completed Last updated 5 August 2021

What this trial tests

trial testing Passeo-18 in Overall Mortality in 132 participants. Completed in 5 July 2021.

Timeline

25 February 2020

Primary endpoint
5 June 2021

5 July 2021

Quick facts

Lead sponsor	Biotronik AG
Status	Completed
Study type	OBSERVATIONAL
Enrollment	132
Start date	25 February 2020
Primary completion	5 June 2021
Estimated completion	5 July 2021
Sites	8 locations across Belgium, Austria, Germany

Drugs / interventions tested

Passeo-18
Passeo-18 Lux

Conditions studied

Overall Mortality — all drugs for Overall Mortality →

Sponsor

Biotronik AG

Who can join

Under 100, any sex, with Overall Mortality. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim is to collect long-term clinical data from 132 patients from Belgium, Germany and Austria who had previously participated in either of the BIOLUX P-I or P-II studies. Patients in these studies were treated with either a percutaneous transluminal angioplasty (PTA) balloon catheter or a drug-coated Passe-18-Lux balloon (DCB). The purpose of Retro-BIOLUX P-I-II is to collect clinical data from patients treated with either Passeo-18 PTA or Passeo-18 Lux DCB to analyze the long-term effects.

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:

Other Biotronik AG trials

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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 NCT04250909 (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 Biotronik AG
Last refreshed: 5 August 2021

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/NCT04250909.

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