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Active Not Recruiting
NCT06832631
VITUS Post-Market Registry
Conditions: Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 284
Sponsor: OrbusNeich
Location: AZORG Aalst
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 \50% after vessel preparation
Source: ClinicalTrials.gov (NCT06832631). StuddyBuddy aggregates publicly available trial information.