Peripheral Arterial DiseaseNCT06832631
VITUS Post-Market Registry
An observational study of Peripheral Arterial Disease and Peripheral Arterial Occlusive Disease, run by OrbusNeich at 13 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease
- What is being tested?
- Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon
- Type of treatment
- Medical device
- How many people
- 283 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 22 May 2025to Jun 2029
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic peripheral arterial disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Belgium6 sites
AZORG
Aalst, 9300
AZ Sint-Blasius
Dendermonde, 9200
ZOL Genk
Genk, 3600
AZ Groennge
Kortrijk, 3000
RZ Heilig Hart Tienen
Tienen, 3300
AZ Jan Portaels
Vilvoorde, 1800
Spain4 sites
Hospital Universitario de Cabueñes
Gijón, 33394
Hospital General de Granollers
Granollers, 08402
Complejo Hospitalario Universitario de Ourense
Ourense, 32005
Hospital Universitario de Toledo
Toledo, 45007
Germany2 sites
Klinikum Lippe Detmold
Detmold, 32756
SRH Klinikum Karlsbad-Langensteinbach GmbH
Karlsbad, 76307
About this study
Official title: 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.
Read the 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.
- Being tested
- Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon
- Keywords
- Peripheral Arterial Disease (PAD), Peripheral Disease, Percutaneous Transluminal Angioplasty (PTA), Drug-Coated Balloon, Drug-Coated Catheter, Drug Coated Balloon (DCB)
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 12 months post-procedure (primary efficacy endpoint at 12 months)
Secondary outcomes (12)
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
Measured: 6 months
Occurrence of Adjudicated freedom from cd-TLR
Adjudicated freedom from clinically driven target lesion revascularization (cd-TLR)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 12 months
Change in Walking Impairment Questionnaire (WIQ) results
Mean change in rate from baseline in Walking Impairment Questionnaire (WIQ) results (telephone interview questionnaire)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start22 May 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 283 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- OrbusNeich
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eucatech AG, Centre Européen de Recherche Cardiovasculaire
- Responsible party
- Sponsor
- Investigators
- Koen Deloose, MD, Principal investigator, AZ St Blasius Dendermonde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832631
- Sponsor's protocol ID
- DVAL-PLAN-064
- Status last verified
- Aug 2026
- First submitted
- 12 Feb 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective PMCF Study of Paclitaxel Drug-coated Balloon Angioplasty for the Treatment of Symptomatic Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT06832631
- Acronym / sponsor ID
- DVAL-PLAN-064
- Keywords
- Peripheral Arterial Disease (PAD), Peripheral Disease, Percutaneous Transluminal Angioplasty (PTA), Drug-Coated Balloon, Drug-Coated Catheter, Drug Coated Balloon (DCB)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 283 participants (actual)
- Lead sponsor
- OrbusNeichIndustry (pharma, biotech, devices)
- Collaborators
- Eucatech AG, Centre Européen de Recherche Cardiovasculaire
- Study start
- 22 May 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VITUS peripheral drug-coated dilatation catheter | – | Device: Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloonThe VITUS peripheral drug-coated dilatation catheter is indicated for use in patients with peripheral arterial occlusive disease (PAOD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic peripheral arterial disease
Key inclusion criteria (4 listed)
- 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.
- Rutherford clinical categories 2-5
Key exclusion criteria (6 listed)
- The patients are excluded from registration if ANY of the following conditions apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloonBalloon angioplasty for the treatment of symptomatic peripheral arterial disease with a paclitaxel drug-coated balloon | Device | VITUS peripheral drug-coated dilatation catheter |
Primary outcome
Proportion of participants with Adjudicated freedom from major adverse events (MAE)
Time frame: 30 days post-procedure (primary safety endpoint at 30 days)
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)
Proportion of participants with Adjudicated freedom from major adverse events (MAE)
Time frame: 12 months post-procedure (primary safety and efficacy endpoint at 12 months)
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
Occurrence of Adjudicated freedom from cd-TLR
Time frame: 12 months post-procedure (primary efficacy endpoint at 12 months)
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 secondary outcomes
Proportion of participants with Adjudicated freedom from MAE
Time frame: 6 months
Occurrence of Adjudicated freedom from cd-TLR
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through hospital discharge (expected to be within 24 hours), 6 months, 12 months, 24 months and 36 months
Change in Rutherford clinical category
Time frame: 12 months
Change in Walking Impairment Questionnaire (WIQ) results
Time frame: 12 months, 24 months, and 36 months
Proportion of participants with Primary patency
Time frame: 12 months, 24 months, and 36 months
Proportion of participants with Device Success
Time frame: Peri-procedural
Proportion of participants with Procedure Success
Time frame: Peri-procedural
Quality of Life Assessment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Deloose, MD principal investigator
AZ St Blasius Dendermonde
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Peripheral Arterial Occlusive Disease, run by OrbusNeich at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Belgium, Spain, Germany, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with Adjudicated freedom from major adverse events (MAE) (time frame: 30 days post-procedure (primary safety endpoint at 30 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.