VITUS Post-Market Registry

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease
• Intervention / Treatment: Device: Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon

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.

• Study Type: Observational
• Enrollment (Estimated): 284

Contacts and Locations

• Study Contact: Name: Jenny Chong, BS; Phone Number: +6012 298-0651; Email: jchong@orbusneich.com

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Recruiting
    • AZORG
    • Contact: Lieven Maene, MD; Phone Number: 053 72 84 84; Email: vaatheelkunde.moorselbaan@azorg.be
  • Dendermonde, Belgium, 9200
    • Recruiting
    • AZ Sint-Blasius
    • Contact: Koen Deloose, MD; Phone Number: 32 52 25 25 17; Email: info@azsintblasius.be
  • Genk, Belgium, 3600
    • Recruiting
    • ZOL GENK
    • Contact: Wouter Lansink, MD; Phone Number: 089 80 82 85; Email: wendy.zwinnen@zol.be
  • Kortrijk, Belgium, 3000
    • Recruiting
    • AZ Groennge
    • Contact: Philip Lerut, MD; Phone Number: 056 63 38 40; Email: vasculairechirurgie@azgroeninge.be
  • Tienen, Belgium, 3300
    • Recruiting
    • RZ Heilig Hart Tienen
    • Contact: Koen Keirse, MD; Phone Number: 32 16 80 90 11
  • Vilvoorde, Belgium, 1800
    • Recruiting
    • AZ Jan Portaels
    • Contact: Jorn Robijn, MD; Phone Number: 32 2 254 64 00; Email: info@azjanportaels.be
• Germany
  • Detmold, Germany, 32756
    • Recruiting
    • Klinikum Lippe Detmold
    • Contact: Dirk Härtel, MD; Phone Number: 05231 72-1181; Email: info@klinikum-lippe.de
  • Karlsbad, Germany, 76307
    • Recruiting
    • SRH Klinikum Karlsbad-Langensteinbach GmbH
    • Contact: Ralph Oberacker, MD; Phone Number: +49 7202 61 - 0; Email: info.kkl@srh.de
• Singapore
  • Singapore, Singapore, 169608
    • Recruiting
    • Singapore General Hospital
    • Contact: Chong Tze Tec, MBBS, FACS, RPVI; Phone Number: (65) 6222 3322; Email: appointments@sgh.com.sg
• Spain
  • Gijón, Spain, 33394
    • Recruiting
    • Hospital Universitario de Cabueñes
    • Contact: Pablo Del Canto Peruyera, MD
  • Granollers, Spain, 08402
    • Recruiting
    • Hospital General de Granollers
    • Contact: Marc Sirvent, MD, PhD; Phone Number: 93 842 50 00
  • Ourense, Spain, 32005
    • Recruiting
    • Complejo Hospitalario Universitario de Ourense
    • Contact: Gracia Rodríguez Feijoo, MD; Phone Number: 34 988 38 55 00
  • Toledo, Spain, 45007
    • Recruiting
    • Hospital Universitario de Toledo
    • Contact: Ángel Flores Herrero, MD, PhD; Phone Number: 34 900 252 525; Email: informacion.toledo@quironsalud.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic peripheral arterial disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Balloon angioplasty for the treatment of symptomatic peripheral arterial disease with a paclitaxel drug-coated balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with Adjudicated freedom from 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 6 months	6 months
Occurrence of Adjudicated freedom from cd-TLR	Adjudicated freedom from clinically driven target lesion revascularization (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)	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	Major amputation-free survival, defined as absence of target limb major amputation (above the ankle)	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	Any amputation-free survival, defined as absence of any amputation in target limb	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 Adjudicated freedom from MAE	Adjudicated freedom from MAE	through hospital discharge (expected to be within 24 hours), 6 months, 12 months, 24 months and 36 months
Change in Rutherford clinical category	Mean change in rate from baseline Rutherford clinical category (clinical assessment at hospital visit)	12 months
Change in Walking Impairment Questionnaire (WIQ) results	Mean change in rate from baseline in Walking Impairment Questionnaire (WIQ) results (telephone interview questionnaire)	12 months, 24 months, and 36 months
Proportion of participants with Primary patency	Primary patency, defined as freedom from >50% restenosis in the target lesion as indicated by a peak systolic velocity ratio >2.4 on duplex ultrasound or by visual assessment of an angiogram (if patients visit hospital), or freedom from clinically-driven reintervention (if telephone contact)	12 months, 24 months, and 36 months
Proportion of participants with Device Success	Device Success: Successful reaching of the target lesion, inflation and deflation of the balloon catheter, and a final residual stenosis after DCB treatment of ≤30% by visual assessment	Peri-procedural
Proportion of participants with Procedure Success	Procedure Success: Successful balloon delivery, deployment, and retrieval, with no peri-procedural death, or target vessel revascularization (TVR)	Peri-procedural
Quality of Life Assessment	Mean change from baseline in European Quality of Life-5 Dimensions (EQ-5D) questionnaire The descriptive system assesses the quality of life and has one question for each of the five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These answers are combined and converted to an index with 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).	12 months

Collaborators and Investigators

• Sponsor: OrbusNeich
• Collaborators: Eucatech AG; Centre Européen de Recherche Cardiovasculaire
• Investigators: Principal Investigator: Koen Deloose, MD, AZ St Blasius Dendermonde

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Drug-Coated Balloon; Peripheral Arterial Disease (PAD); Percutaneous Transluminal Angioplasty (PTA); Peripheral Disease; Drug-Coated Catheter; Drug Coated Balloon (DCB)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease 1; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Catheterization; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Angioplasty
• Other Study ID Numbers: DVAL-PLAN-064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No