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Clinical Trials in Germany / NCT06678490
Active, not recruiting Observational

Support C Post-Market Registry

NCT06678490 · tracked via the Priya Life Science Germany tracker
Sponsor
OrbusNeich
Phase
Observational
Started
2025-07-09
Last updated
2026-02-10

Condition(s) studied

Coronary Arteriosclerosis

Study summary

To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the drug eluting Support C PTCA balloon catheter when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Support C Drug Coated Balloon (DCB) in routine clinical practice.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Consecutive patients intended to be, or treated by Support C DCB as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry. Note: 1. In case of major dissection requiring bailout stenting after DCB use the patients will be included in the registry and followed as per study schedule. 2. If major dissection occurred after lesion preparation, but before DCB use and lesion was stented, the patient will not be included in the registry. Exclusion Criteria: * Patients are excluded if ANY of the following additional conditions apply: * High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned * A life expectancy of \<1year * Explicit refusal of participation in the registry

Primary outcome measure(s)

  • Adjudicated, device-oriented, Target Lesion Failure (TLF) — 12 months post procedure
    Adjudicated, device-oriented, Target Lesion Failure (TLF) where TLF is defined as a composite of cardiac death (CD), non-fatal myocardial infarction (MI) not clearly attributable to a non-target vessel (TV-MI), or clinically driven target lesion revascularization (cd-TLR) (by PCI or coronary artery bypass grafting).

Trial sites (12)

FacilityCityRegionStatus
Krajska nemocnice Liberec Liberec Czechia
Motol University Hospital Prague Czechia
Katholischen Krankenhaus "St. Johann Nepomuk" Erfurt Germany
Evangelisches Krankenhaus Hagen-Haspe gGmbH Hagen Germany
MediClin Herzzentrum Lahr Lahr Germany
Martha Maria Nürnberg Nuremberg Germany
National Heart Institute (Institut Jantung Negara) Kuala Lumpur Malaysia
Hospital de la Santa Creu i Sant Pau Barcelona Spain
Hospital Universitario Lucus Augusti Lugo Spain
Hospital Universitario de La Princesa Madrid Spain
Hospital Universitario Virgen de la Arrixaca Murcia Spain
Hospital Universitario Virgen del Rocío Seville Spain

More OrbusNeich trials in Germany

VITUS Post-Market Registry Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06678490 on ClinicalTrials.gov ↗ ← All trials in Germany