Who is sponsoring NCT04470934?

NCT04470934 is sponsored by B. Braun Melsungen AG.

What drugs are being tested in NCT04470934?

Interventions in NCT04470934: SeQuent® SCB drug-coated balloon catheter.

What condition does NCT04470934 study?

NCT04470934 studies Coronary Artery Disease, Myocardial Ischaemia.

Is NCT04470934 still recruiting?

NCT04470934 is currently active, enrolled. Last updated 15 January 2025.

Last reviewed 2025-01-15 · How we verify

NCT04470934: SCORE

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

SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)

Active, enrolled Last updated 15 January 2025

What this trial tests

trial testing SeQuent® SCB drug-coated balloon catheter in Coronary Artery Disease in 1,302 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 April 2021

Primary endpoint
31 January 2026

31 March 2027

Quick facts

Lead sponsor	B. Braun Melsungen AG
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	1,302
Start date	30 April 2021
Primary completion	31 January 2026
Estimated completion	31 March 2027
Sites	1 location across Germany

Drugs / interventions tested

SeQuent® SCB drug-coated balloon catheter

Conditions studied

Coronary Artery Disease — all drugs for Coronary Artery Disease →
Myocardial Ischaemia — all drugs for Myocardial Ischaemia →

Sponsor

B. Braun Melsungen AG — full company profile →

Who can join

18 and older, any sex, with Coronary Artery Disease or Myocardial Ischaemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the study is to assess continued safety and efficacy of the SeQuent® SCB. The product under investigation will be used in routine clinical practice according to the latest European Society of Cardiology (ESC) guidelines and according to the Instructions for Use (IFU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).

Publications & conference data

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

Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: rationale, methodology and design of the SCORE trial.
Otto S, Díaz VAJ, Weilenmann D, Cuculi F, et al · · 2023 · cited 4× · PMID 37003986 · DOI 10.1186/s12872-023-03187-x
Treatment of coronary lesions with a novel crystalline sirolimus-coated balloon.
Madanchi M, Attinger-Toller A, Gjergjizi V, Majcen I, et al · · 2024 · cited 1× · PMID 38414923 · DOI 10.3389/fcvm.2024.1316580
Crystalline Sirolimus-Coated Balloon (cSCB) Angioplasty in an all-comers,patient population with stable and unstable coronary artery disease including chronic total occlusions: Rationale, methodology and design of the SCORE trial
Otto S, Díaz VAJ, Weilenmann D, Cuculi F, et al · · 2023 · DOI 10.21203/rs.3.rs-2451050/v1

Verify or expand the search:

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 B. Braun Melsungen AG trials

Trials by the same sponsor.

NCT05124821 — Evaluation of Performance Over Dwell Time and Safety of the Central-venous Catheters Certofix® Paed · completed
NCT04649931 — Differences in Exhaled Breath by Using Ion Mobility Spectrometry (IMS) in Subjects Tested for SARS-CoV-2 Infection (COVI · completed
NCT04556318 — Identification of Differences in Breath Components Detected With IMS in Patients Tested on SARS-CoV-2 (COVID-19) · completed
NCT03809715 — Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF) · completed
NCT03282955 — The HOME Study (HPN With OMEGA-3) · Phase 4 · completed

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 NCT04470934 (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 B. Braun Melsungen AG
Last refreshed: 15 January 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/NCT04470934.

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