Clinical trial NCT06832631: VITUS Post-Market Registry
Official title: A Prospective PMCF Study of Paclitaxel Drug-coated Balloon Angioplasty for the Treatment of Symptomatic Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Peripheral Arterial Occlusive Disease
Keywords: Peripheral Arterial Disease (PAD)
Peripheral Disease
Percutaneous Transluminal Angioplasty (PTA)
Drug-Coated Balloon
Drug-Coated Catheter
Drug Coated Balloon (DCB)
Lead sponsor: OrbusNeich
Sponsor class: INDUSTRY
Collaborators: name: Eucatech AG
name: Centre Européen de Recherche Cardiovasculaire
First posted: 2025-02-18
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic peripheral arterial disease

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.

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

Primary outcomes:
measure: Proportion of participants with Adjudicated freedom from major adverse events (MAE)
timeFrame: 30 days post-procedure (primary safety endpoint at 30 days)
measure: Proportion of participants with Adjudicated freedom from major adverse events (MAE)
timeFrame: 12 months post-procedure (primary safety and efficacy endpoint at 12 months)
measure: Occurrence of Adjudicated freedom from cd-TLR
timeFrame: 12 months post-procedure (primary efficacy endpoint at 12 months)
Secondary outcomes:
measure: Proportion of participants with Adjudicated freedom from MAE
timeFrame: 6 months
measure: Occurrence of Adjudicated freedom from cd-TLR
timeFrame: through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 24 months and 36 months
measure: Occurrence of Adjudicated freedom from clinically driven target vessel revascularization (cd-TVR)
timeFrame: through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months
measure: Proportion of participants with Major amputation-free survival
timeFrame: through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months
measure: Proportion of participants with Any amputation-free survival
timeFrame: through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months
measure: Proportion of participants with Adjudicated freedom from MAE
timeFrame: through hospital discharge (expected to be within 24 hours), 6 months, 12 months, 24 months and 36 months
measure: Change in Rutherford clinical category
timeFrame: 12 months
measure: Change in Walking Impairment Questionnaire (WIQ) results
timeFrame: 12 months, 24 months, and 36 months
measure: Proportion of participants with Primary patency
timeFrame: 12 months, 24 months, and 36 months
measure: Proportion of participants with Device Success
timeFrame: Peri-procedural
measure: Proportion of participants with Procedure Success
timeFrame: Peri-procedural
measure: Quality of Life Assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Karlsbad
country: Germany
facility: SRH Klinikum Karlsbad-Langensteinbach GmbH
Study officials:
affiliation: AZ St Blasius Dendermonde
name: Koen Deloose, MD
role: PRINCIPAL_INVESTIGATOR
References: