Support C Post-Market Registry

NCT06678490 | Active Not Recruiting

• 1 other identifier: DVAL-PLAN-063
• Study Type: observational
• Target: 282
• Locations: 4 countries
• Sites: 12

Brief 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.

Conditions

Coronary Arteriosclerosis

Keywords

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arterioscherosis; Cardiovascular Diseases; Drug Coated Balloon; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• 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.
• If major dissection occurred after lesion preparation, but before DCB use and lesion was stented, the patient will not be included in the registry.

You may not qualify if:

• 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

Sponsors & Collaborators

• OrbusNeich: lead
• Eucatech AG: collaborator
• European Cardiovascular Research Center: collaborator

Study Sites (12)

Krajska nemocnice Liberec

Liberec, 46001, Czechia

Location

Motol University Hospital

Prague, 15006, Czechia

Location

Katholischen Krankenhaus "St. Johann Nepomuk"

Erfurt, 99097, Germany

Location

Evangelisches Krankenhaus Hagen-Haspe gGmbH

Hagen, 58135, Germany

Location

MediClin Herzzentrum Lahr

Lahr, 77933, Germany

Location

Martha Maria Nürnberg

Nuremberg, 90491, Germany

Location

National Heart Institute (Institut Jantung Negara)

Kuala Lumpur, 50400, Malaysia

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08026, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Fernando Alfonso, MD, PhD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: July 9, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1); ES (5); DE (4); CZ (2)