VITUS Post-Market Registry

OrbusNeich284 enrolled

Overview

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.

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

284

Conditions

Peripheral Arterial Disease Peripheral Arterial Occlusive Disease

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

AZORG

Aalst, Belgium

RECRUITING

AZ Sint-Blasius

Dendermonde, Belgium

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: 12 months post-procedure (primary efficacy endpoint at 12 months)

Secondary Outcomes

Proportion of participants with Adjudicated freedom from MAE

Time frame: 6 months

Occurrence of Adjudicated freedom from cd-TLR

Adjudicated freedom from clinically driven target lesion revascularization (cd-TLR)

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

Central Contacts

Jenny Chong, BS

CONTACT

+6012 298-0651 jchong@orbusneich.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

AZ Groennge

Kortrijk, Belgium

RECRUITING

RZ Heilig Hart Tienen

Tienen, Belgium

RECRUITING

AZ Jan Portaels

Vilvoorde, Belgium

RECRUITING

Klinikum Lippe Detmold

Detmold, Germany

RECRUITING

SRH Klinikum Karlsbad-Langensteinbach GmbH

Karlsbad, Germany

RECRUITING

Hospital Universitario de Cabueñes

Gijón, Spain

RECRUITING

Hospital General de Granollers

Granollers, Spain

RECRUITING

...and 2 more locations

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

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

Major amputation-free survival, defined as absence of target limb major amputation (above the ankle)

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

Any amputation-free survival, defined as absence of any amputation in target limb

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

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

Mean change in rate from baseline Rutherford clinical category (clinical assessment at hospital visit)

Time frame: 12 months

Change in Walking Impairment Questionnaire (WIQ) results

Mean change in rate from baseline in Walking Impairment Questionnaire (WIQ) results (telephone interview questionnaire)

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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).

Time frame: 12 months