Active, not recruitingNo phase
VITUS Post-Market Registry
Key facts
- Who runs it
- OrbusNeich
- Where
- Belgium, Germany, Singapore, and Spain13 sites in 4 countriesChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 283 people enrolled
- Started
- 22 May 2025
- Expected to end
- Jun 2029
- Type of study
- Observational
- Treatments tested
- Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon
- Record updated
- 13 August 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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 cannot take part
- 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
This trial has no sites in United States.
It has sites in 4 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- VITUS peripheral drug-coated dilatation catheter
The VITUS peripheral drug-coated dilatation catheter is indicated for use in patients with peripheral arterial occlusive disease (PAOD).
Treatment: Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective PMCF Study of Paclitaxel Drug-coated Balloon Angioplasty for the Treatment of Symptomatic Peripheral Arterial Disease
- Record updated
- 13 August 2026