NCT06832631

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started May 2025

Longer than P75 for all trials

Geographic Reach
4 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
May 2025Apr 2029

First Submitted

Initial submission to the registry

February 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 22, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

February 12, 2025

Last Update Submit

March 9, 2026

Conditions

Peripheral Arterial DiseasePeripheral Arterial Occlusive Disease

Keywords

Peripheral Arterial Disease (PAD)Peripheral DiseasePercutaneous Transluminal Angioplasty (PTA)Drug-Coated BalloonDrug-Coated CatheterDrug Coated Balloon (DCB)

Outcome Measures

Primary Outcomes (3)

  • Proportion of participants with Adjudicated freedom from major adverse events (MAE)

    Adjudicated freedom from major adverse events (MAE), where MAE is defined as a composite of device- and procedure-related mortality, freedom from major target limb amputation, and freedom from clinically driven target lesion revascularization (cd-TLR)

    30 days post-procedure (primary safety endpoint at 30 days)

  • Proportion of participants with Adjudicated freedom from major adverse events (MAE)

    Adjudicated freedom from MAE, where MAE is defined as a composite of device- and procedure-related mortality through 30 days, freedom from major target limb amputation, and freedom from clinically driven target lesion revascularization (cd-TLR) within 12 months

    12 months post-procedure (primary safety and efficacy endpoint at 12 months)

  • Occurrence of Adjudicated freedom from cd-TLR

    Adjudicated freedom from cd-TLR, where cd-TLR is defined as any reintervention performed for ≥50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms

    12 months post-procedure (primary efficacy endpoint at 12 months)

Secondary Outcomes (12)

  • Proportion of participants with Adjudicated freedom from MAE

    6 months

  • Occurrence of Adjudicated freedom from cd-TLR

    through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 24 months and 36 months

  • Occurrence of Adjudicated freedom from clinically driven target vessel revascularization (cd-TVR)

    through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months

  • Proportion of participants with Major amputation-free survival

    through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months

  • Proportion of participants with Any amputation-free survival

    through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months

  • +7 more secondary outcomes

Study Arms (1)

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).

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

Interventions

Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloonDEVICE

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

VITUS peripheral drug-coated dilatation catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with symptomatic peripheral arterial disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

AZORG

Aalst, 9300, Belgium

RECRUITING

AZ Sint-Blasius

Dendermonde, 9200, Belgium

RECRUITING

ZOL Genk

Genk, 3600, Belgium

RECRUITING

AZ Groennge

Kortrijk, 3000, Belgium

RECRUITING

RZ Heilig Hart Tienen

Tienen, 3300, Belgium

RECRUITING

AZ Jan Portaels

Vilvoorde, 1800, Belgium

RECRUITING

Klinikum Lippe Detmold

Detmold, 32756, Germany

RECRUITING

SRH Klinikum Karlsbad-Langensteinbach GmbH

Karlsbad, 76307, Germany

RECRUITING

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

Hospital Universitario de Cabueñes

Gijón, 33394, Spain

RECRUITING

Hospital General de Granollers

Granollers, 08402, Spain

RECRUITING

Complejo Hospitalario Universitario de Ourense

Ourense, 32005, Spain

RECRUITING

Hospital Universitario de Toledo

Toledo, 45007, Spain

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial DiseasePeripheral Arterial Occlusive Disease 1

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Koen Deloose, MD

    AZ St Blasius Dendermonde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Chong, BS

CONTACT

+6012 298-0651jchong@orbusneich.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2025

First Posted

February 18, 2025

Study Start

May 22, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2029

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(6)SG(1)ES(4)DE(2)