Support C Post-Market Registry

Launched by ORBUSNEICH · Nov 6, 2024

Keywords

ClinConnect Summary

The Support C Post-Market Registry is a study designed to gather important information about the long-term safety and effectiveness of a specific medical device called the Support C Drug Coated Balloon (DCB). This device is used to treat patients with coronary arteriosclerosis, a condition where the arteries supplying blood to the heart become narrowed. The goal of the trial is to collect data on patients who receive this treatment in everyday medical settings, helping healthcare providers understand how well the device works over time.

To participate in this study, patients must be between the ages of 65 to 74 and must be treated with the Support C DCB as decided by their doctors. Participants will be monitored following the standard care procedures after receiving the treatment. However, patients who are unlikely to follow up for any reason, are part of other studies, have a life expectancy of less than one year, or choose not to participate will not be included. This registry aims to ensure that the Support C DCB is safe and effective for patients in real-world situations.

Gender

ALL

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