Support C Post-Market Registry

PMCF Registry Study Paclitaxel-eluting Balloon Catheter Support C

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Arteriosclerosis

Detailed Description

This multicenter, prospective registry population consists of consecutive patients with coronary heart disease who undergo percutaneous coronary intervention (PCI) and are intended to be or treated by the Support C Drug Coated Balloon (DCB) according to the Instructions for Use as part of routine clinical care. Approximately 278 patients from 8-12 centers in Europe will be entered into the registry. Patients in the registry are followed for three years. The registry is considered finished when all patients have completed the 36-month follow-up.

A follow-up is scheduled at the following timepoints: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, 36 months. Follow-up is obtained by telephone contact with the patient or at a planned hospital visit.

• Study Type: Observational
• Enrollment (Actual): 282

Contacts and Locations

Study Locations

• Czechia
  • Liberec, Czechia, 46001
    • Krajská nemocnice Liberec
  • Prague, Czechia, 15006
    • Motol University Hospital
• Germany
  • Erfurt, Germany, 99097
    • Katholischen Krankenhaus "St. Johann Nepomuk"
  • Hagen, Germany, 58135
    • Evangelisches Krankenhaus Hagen-Haspe gGmbH
  • Lahr, Germany, 77933
    • MediClin Herzzentrum Lahr
  • Nuremberg, Germany, 90491
    • Martha Maria Nürnberg
• Malaysia
  • Kuala Lumpur, Malaysia, 50400
    • National Heart Institute (Institut Jantung Negara)
• Spain
  • Barcelona, Spain, 08026
    • Hospital De La Santa Creu I Sant Pau
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de La Arrixaca
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocío

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic ischemic coronary heart disease due to discrete de novo lesions or restenosis of the coronary arteries as well as arterial or venous bypasses can be included in the study. The vessel diameter must be 2.0 - 4.0 mm.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Drug Eluting SUPPORT C PTCA balloon catheter; The Drug Eluting SUPPORT C PTCA balloon catheter is indicated for use in patients with symptomatic ischaemic coronary heart disease due to discrete de novo lesions or restenosis of the coronary arteries as well as arterial or venous bypasses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjudicated, device-oriented, Target Lesion Failure (TLF)	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).	12 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjudicated bleeding Type 3-5 per the Bleeding Academic Research Consortium (BARC) definition		through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Adjudicated stroke		through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Adjudicated Target Lesion Failure (TLF)		through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 24 months, and 36 months
Each of the components of TLF (cardiac death (CD), non-fatal myocardial infarction not clearly attributable to a non-target vessel (TV-MI), and clinically driven target lesion revascularization (cd-TLR) )		through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Adjudicated Target Vessel Failure (TVF) a composite of all Cardiovascular Death (CVD), TV-MI, and clinically driven Target Vessel Revascularization (cd-TVR)		through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Each of the components of TVF (Cardiovascular Death (CVD), TV-MI, and clinically driven Target Vessel Revascularization (cd-TVR) )		through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Adjudicated lesion thrombosis		through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Device success	Successful reaching of the target lesion, successful inflation and deflation of the balloon catheter, and a final residual stenosis after DCB treatment of ≤30% by visual assessment in the presence of grade 3 TIMI (Thrombolysis in Myocardial Infarction) flow, by visual estimation.	Index Procedure
Procedure success	Procedure success: Successful balloon delivery, deployment and retrieval and no peri-procedural death, TV-MI or TVR.	Index Procedure

Collaborators and Investigators

• Sponsor: OrbusNeich
• Collaborators: European Cardiovascular Research Center; Eucatech AG
• Investigators: Principal Investigator: Fernando Alfonso, MD, PhD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Coronary Artery Disease; Ischemic Heart Disease; Heart Diseases; Myocardial Ischemia; Coronary Disease; Drug Coated Balloon; Arterioscherosis
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: DVAL-PLAN-063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No