VITUS Post-Market Registry
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A vizsgálat adatai
- Ki végzi
- OrbusNeich
- Azonosító
- NCT06832631
- A regiszteradat frissítve
- 2026. augusztus 13.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
A Prospective PMCF Study of Paclitaxel Drug-coated Balloon Angioplasty for the Treatment of Symptomatic Peripheral Arterial Disease
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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.