VITUS Post-Market Registry

Launched by ORBUSNEICH · Feb 12, 2025

Keywords

ClinConnect Summary

The VITUS Post-Market Registry is a clinical trial designed to gather information about the long-term safety and effectiveness of a specific medical device called the VITUS peripheral drug-coated dilatation catheter. This device is used to treat patients with conditions affecting blood flow in the legs, known as Peripheral Arterial Disease (PAD) and Peripheral Arterial Occlusive Disease (PAOD). The trial aims to monitor how well this device performs in everyday medical settings and to ensure it is safe for patients over time.

To be considered for this trial, patients should be between the ages of 65 to 74 and are expected to receive treatment with the VITUS catheter as decided by their doctor. Eligible participants must have a specific type of blockage in their arteries that can be treated with this device. Those who are likely to struggle with follow-up appointments or are currently involved in other studies may not be able to participate. If enrolled, participants can expect regular check-ins to monitor their health and the results of the treatment, contributing valuable information to improve patient care in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Consecutive patients intended to be or treated by the VITUS peripheral drug-coated dilatation catheter as per physicians' decision and according to IFU in the setting of routine clinical care are entered into the registry
• • The lesion to be treated should be shorter than the nominal length of balloon at a reference vessel diameter of 2.0 mm up to 7.0 mm.
• • If lesion is longer than the individual balloon, more than one DCB can be used for longer lesions with the mandatory overlapping balloons of 10mm to avoid any geographical miss.
• • Rutherford clinical categories 2-5
• Exclusion Criteria:
• * The patients are excluded from registration if ANY of the following 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 in peripheral arteries is planned
• • A life expectancy of \<1year
• • Explicit refusal of participation in the registry
• • Residual stenosis \>50% after vessel preparation