Actively Recruiting

Age: 18Years +
All Genders
NCT06832631

VITUS Post-Market Registry

Led by OrbusNeich · Updated on 2026-03-11

284

Participants Needed

13

Research Sites

201 weeks

Total Duration

On this page

Sponsors

O

OrbusNeich

Lead Sponsor

E

Eucatech AG

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

VITUS Post-Market Registry

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients intended to be or treated with the VITUS peripheral drug-coated dilatation catheter as per physician decision and instructions for use
  • Treated lesion shorter than the balloon length at vessel diameter between 2.0 mm and 7.0 mm
  • Multiple overlapping balloons allowed for longer lesions with 10 mm overlap
  • Rutherford clinical categories 2 to 5
Not Eligible

You will not qualify if you...

  • High likelihood of not adhering to follow-up due to social, psychological, or medical reasons
  • Participation in another investigational drug or device study involving routine angiographic follow-up in peripheral arteries
  • Life expectancy less than 1 year
  • Explicit refusal to participate in the registry
  • Residual stenosis greater than 50% after vessel preparation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

AZORG

Aalst, Belgium, 9300

Actively Recruiting

2

AZ Sint-Blasius

Dendermonde, Belgium, 9200

Actively Recruiting

3

ZOL Genk

Genk, Belgium, 3600

Actively Recruiting

4

AZ Groennge

Kortrijk, Belgium, 3000

Actively Recruiting

5

RZ Heilig Hart Tienen

Tienen, Belgium, 3300

Actively Recruiting

6

AZ Jan Portaels

Vilvoorde, Belgium, 1800

Actively Recruiting

7

Klinikum Lippe Detmold

Detmold, Germany, 32756

Actively Recruiting

8

SRH Klinikum Karlsbad-Langensteinbach GmbH

Karlsbad, Germany, 76307

Actively Recruiting

9

Singapore General Hospital

Singapore, Singapore, 169608

Actively Recruiting

10

Hospital Universitario de Cabueñes

Gijón, Spain, 33394

Actively Recruiting

11

Hospital General de Granollers

Granollers, Spain, 08402

Actively Recruiting

12

Complejo Hospitalario Universitario de Ourense

Ourense, Spain, 32005

Actively Recruiting

13

Hospital Universitario de Toledo

Toledo, Spain, 45007

Actively Recruiting

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Research Team

J

Jenny Chong, BS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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VITUS Post-Market Registry | DecenTrialz