RECRUITINGOBSERVATIONAL
VITUS Post-Market Registry
A Prospective PMCF Study of Paclitaxel Drug-coated Balloon Angioplasty for the Treatment of Symptomatic Peripheral Arterial Disease
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon
Balloon angioplasty for the treatment of symptomatic peripheral arterial disease with a paclitaxel drug-coated balloon
Locations (13)
AZORG
Aalst, Belgium
AZ Sint-Blasius
Dendermonde, Belgium
ZOL Genk
Genk, Belgium
AZ Groennge
Kortrijk, Belgium
RZ Heilig Hart Tienen
Tienen, Belgium
AZ Jan Portaels
Vilvoorde, Belgium
Klinikum Lippe Detmold
Detmold, Germany
SRH Klinikum Karlsbad-Langensteinbach GmbH
Karlsbad, Germany
Singapore General Hospital
Singapore, Singapore
Hospital Universitario de Cabueñes
Gijón, Spain
Hospital General de Granollers
Granollers, Spain
Complejo Hospitalario Universitario de Ourense
Ourense, Spain
Hospital Universitario de Toledo
Toledo, Spain