Registry for patients treated with the VITUS drug-coated catheter

A Prospective PMCF Study of Paclitaxel Drug-coated Balloon Angioplasty for the Treatment of Symptomatic Peripheral Arterial Disease

This study is collecting information from around 284 patients with blocked leg arteries who are treated with the VITUS drug-coated catheter to see how well it works and how safe it is over three years.

Quick facts

• Study type: Observational
• Enrollment: 284 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: OrbusNeich (Industry-sponsored)
• Locations: 13 sites (Aalst and 12 other locations)
• Trial ID: NCT06832631 on ClinicalTrials.gov

What this trial studies

This observational registry collects data on patients with peripheral arterial occlusive disease who are treated with the VITUS peripheral drug-coated dilatation catheter during routine clinical care. The study involves approximately 284 patients across 15 centers in Europe, with follow-ups scheduled at various time points over three years to assess the long-term safety and performance of the catheter. Data will be gathered through patient contacts and hospital visits to monitor outcomes post-procedure.

Who should consider this trial

Good fit: Ideal candidates include patients with peripheral arterial occlusive disease who are intended to be treated with the VITUS drug-coated catheter as part of their routine clinical care.

Not a fit: Patients with a high probability of non-adherence to follow-up requirements or those currently participating in another investigational study may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the long-term safety and effectiveness of the VITUS catheter, potentially improving treatment options for patients with peripheral arterial disease.

How similar studies have performed: Other studies involving drug-coated balloons for peripheral arterial disease have shown promising results, indicating that this approach is supported by prior successful outcomes.

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

Where this trial is running

Aalst and 12 other locations

• Azorg — Aalst, Belgium (Recruiting)
• AZ Sint-Blasius — Dendermonde, Belgium (Recruiting)
• ZOL Genk — Genk, Belgium (Recruiting)
• AZ Groennge — Kortrijk, Belgium (Recruiting)
• RZ Heilig Hart Tienen — Tienen, Belgium (Recruiting)
• AZ Jan Portaels — Vilvoorde, Belgium (Recruiting)
• Klinikum Lippe Detmold — Detmold, Germany (Recruiting)
• SRH Klinikum Karlsbad-Langensteinbach GmbH — Karlsbad, Germany (Recruiting)
• Singapore General Hospital — Singapore, Singapore (Recruiting)
• Hospital Universitario de Cabueñes — Gijón, Spain (Recruiting)
• Hospital General de Granollers — Granollers, Spain (Recruiting)
• Complejo Hospitalario Universitario de Ourense — Ourense, Spain (Recruiting)
• Hospital Universitario de Toledo — Toledo, Spain (Recruiting)

Study contacts

• Principal investigator: Koen Deloose, MD — AZ St Blasius Dendermonde
• Study coordinator: Jenny Chong, BS

Conditions Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease; Peripheral Disease; Percutaneous Transluminal Angioplasty; Drug-Coated Balloon; Drug-Coated Catheter; Drug Coated Balloon