| NCT ID | NCT06832631 |
| Status | Recruiting |
| Phase | — |
| Sponsor | OrbusNeich |
| Condition | Peripheral Arterial Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 284 participants |
| Start Date | 2025-05-22 |
| Primary Completion | 2027-04 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
To collect post marketing surveillance data on consecutive patients with peripheral arterial occlusive disease (PAOD) intended to be or treated by the VITUS peripheral drug-coated dilatation catheter when used according to the Instructions for Use and treating physician decision. Data will be collected in order to assess the long-term safety and performance of the VITUS peripheral drug-coated dilatation catheter in routine clinical practice.
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