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VITUS Post-Market Registry

Active Not RecruitingN/A

Sponsor: OrbusNeich

Conditions: Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease

Interventions: Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon

Countries: Belgium, Germany, Singapore, Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (13)

Aalst, Belgium
Dendermonde, Belgium
Genk, Belgium
Kortrijk, Belgium
Tienen, Belgium
Vilvoorde, Belgium
Detmold, Germany
Karlsbad, Germany
Singapore, Singapore
Gijón, Spain
Granollers, Spain
Ourense, Spain
Toledo, Spain