Clinical trial NCT06678490: Support C Post-Market Registry
Official title: PMCF Registry Study Paclitaxel-eluting Balloon Catheter Support C
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Arteriosclerosis
Keywords: Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arterioscherosis
Cardiovascular Diseases
Drug Coated Balloon
Ischemic Heart Disease
Lead sponsor: OrbusNeich
Sponsor class: INDUSTRY
Collaborators: name: Eucatech AG
name: European Cardiovascular Research Center
First posted: 2024-11-07
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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 outcomes:
measure: Adjudicated, device-oriented, Target Lesion Failure (TLF)
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Adjudicated Target Lesion Failure (TLF)
timeFrame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 24 months, and 36 months
measure: 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) )
timeFrame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
measure: Adjudicated Target Vessel Failure (TVF) a composite of all Cardiovascular Death (CVD), TV-MI, and clinically driven Target Vessel Revascularization (cd-TVR)
timeFrame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
measure: Each of the components of TVF (Cardiovascular Death (CVD), TV-MI, and clinically driven Target Vessel Revascularization (cd-TVR) )
timeFrame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
measure: Adjudicated bleeding Type 3-5 per the Bleeding Academic Research Consortium (BARC) definition
timeFrame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
measure: Adjudicated stroke
timeFrame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
measure: Adjudicated lesion thrombosis
timeFrame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
measure: Device success
timeFrame: Index Procedure
measure: Procedure success
timeFrame: Index Procedure
Other outcomes:
Locations:
Study officials:
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Fernando Alfonso, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: