Coronary Arteriosclerosis
Conditions
Keywords
Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arterioscherosis, Cardiovascular Diseases, Drug Coated Balloon, Ischemic Heart Disease
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.
Interventions
None listed
Sponsors
OrbusNeich
Eucatech AG
European Cardiovascular Research Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Adjudicated stroke | 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 | Index Procedure | 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. |
| Procedure success | Index Procedure | Procedure success: Successful balloon delivery, deployment and retrieval and no peri-procedural death, TV-MI or TVR. |
Countries
Czechia, Germany, Malaysia, Spain
Contacts
PRINCIPAL_INVESTIGATORFernando Alfonso, MD, PhD
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Outcome results
None listed