VITUS Post-Market Registry

NCT ID: NCT06832631

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 284 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-22
• Study Completion Date: 2029-04-30

Brief Summary

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.

Detailed Description

The multicenter, prospective registry population consists of consecutive patients with peripheral arterial occlusive disease (PAOD) who undergo percutaneous transluminal angioplasty (PTA) intervention and are intended to be or treated by the VITUS peripheral drug-coated dilatation catheter (according to the Instructions for Use) as part of routine clinical care. Approximately 284 patients from approximately 15 centers in Europe will be entered into the registry. Patients entered into the registry are followed for three years. The registry is considered finished when all patients have completed the 36-month follow-up.

A follow-up is scheduled at the following timepoints: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, and 36 months. Follow-up is obtained by telephone contact with the patient or at a planned hospital visit.

Conditions

Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon

Intervention Type: DEVICE

Balloon angioplasty for the treatment of symptomatic peripheral arterial disease with a paclitaxel drug-coated balloon

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eucatech AG

INDUSTRY

Sponsor Role: collaborator

Centre Européen de Recherche Cardiovasculaire

UNKNOWN

Sponsor Role: collaborator

OrbusNeich

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Koen Deloose, MD

Role: PRINCIPAL_INVESTIGATOR

AZ St Blasius Dendermonde

Locations

AZORG

Aalst, , Belgium

Site Status: RECRUITING

AZ Sint-Blasius

Dendermonde, , Belgium

Site Status: RECRUITING

ZOL Genk

Genk, , Belgium

Site Status: RECRUITING

AZ Groennge

Kortrijk, , Belgium

Site Status: RECRUITING

RZ Heilig Hart Tienen

Tienen, , Belgium

Site Status: RECRUITING

AZ Jan Portaels

Vilvoorde, , Belgium

Site Status: RECRUITING

Klinikum Lippe Detmold

Detmold, , Germany

Site Status: RECRUITING

SRH Klinikum Karlsbad-Langensteinbach GmbH

Karlsbad, , Germany

Site Status: RECRUITING

Hospital General de Granollers

Granollers, , Spain

Site Status: RECRUITING

Complejo Hospitalario Universitario de Ourense

Ourense, , Spain

Site Status: RECRUITING

Hospital Universitario de Toledo

Toledo, , Spain

Site Status: RECRUITING

Countries

Belgium; Germany; Spain

Central Contacts

Jenny Chong, BS

Role: CONTACT

jchong@orbusneich.com

+6012 298-0651

Facility Contacts

Lieven Maene, MD

Role: primary

vaatheelkunde.moorselbaan@azorg.be

053 72 84 84

Koen Deloose, MD

Role: primary

info@azsintblasius.be

32 52 25 25 17

Wouter Lansink, MD

Role: primary

wendy.zwinnen@zol.be

089 80 82 85

Philip Lerut, MD

Role: primary

vasculairechirurgie@azgroeninge.be

056 63 38 40

Koen Keirse, MD

Role: primary

32 16 80 90 11

Jorn Robijn, MD

Role: primary

info@azjanportaels.be

32 2 254 64 00

Dirk Härtel, MD

Role: primary

info@klinikum-lippe.de

05231 72-1181

Ralph Oberacker, MD

Role: primary

info.kkl@srh.de

+49 7202 61 - 0

Marc Sirvent, MD, PhD

Role: primary

93 842 50 00

Gracia Rodríguez Feijoo, MD

Role: primary

34 988 38 55 00

Ángel Flores Herrero, MD, PhD

Role: primary

informacion.toledo@quironsalud.es

34 900 252 525

Other Identifiers

DVAL-PLAN-064

Identifier Type: -

Identifier Source: org_study_id