Support C Post-Market Registry

N/AActive Not RecruitingNCT06678490

OrbusNeich282 enrolled

Overview

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.

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

282

Conditions

Coronary Arteriosclerosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Krajska nemocnice Liberec

Liberec, Czechia

Motol University Hospital

Prague, Czechia

Katholischen Krankenhaus "St. Johann Nepomuk"

Erfurt, Germany

Outcomes

Primary Outcomes

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).

Time frame: 12 months post procedure

Secondary Outcomes

Adjudicated Target Lesion Failure (TLF)

Time frame: 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) )

Time frame: 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)

Time frame: 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) )

Time frame: 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

Time frame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months

Data from ClinicalTrials.gov

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