Clinical trial NCT02746159: Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae
Official title: A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon PTA Catheter for Treatment of Dysfunctional Native and Synthetic AV Fistulae
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arteriovenous Fistula
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm.

Brief summary: The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and followed clinically for a minimum of 12 months.

Detailed description: This post market registry is intended to demonstrate safety and assess the clinical use and outcomes of the Lutonix DCB in a heterogeneous patient population with dysfunctional native or synthetic AV fistulae in real world clinical practice.

Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant, non-breastfeeding female ≥18 years of age;
2. Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits;
3. Native or synthetic (grafts) arteriovenous fistula located in the arm, including central veins, presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines; and
4. Lesion(s) can be treated with available Lutonix DCB device size matrix per current IFU.

Exclusion Criteria:

Patients will be excluded if ANY of the following conditions apply:

1. Patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. Lutonix Global AV registry).
2. Patient has a non-controllable allergy to contrast; or
3. Patient has another medical condition that, which in the opinion of the Investigator, may confound the data interpretation of is associated with a life expectancy insufficient to allow for completion of patient registry procedure and follow up.

Primary outcomes:
measure: Proportion of subjects with freedom from any serious adverse event(s) involving the AV access circuit
timeFrame: 30 days.
measure: Proportion of subjects with target lesion primary patency
timeFrame: 6 Months
Secondary outcomes:
measure: Proportion of subjects with access circuit primary patency at 3, 6, and 12 months
timeFrame: 12 months
measure: Proportion of Subjects withTarget Lesion Primary Patency (TLPP)
timeFrame: 12 months
measure: Proportion of Subjects with Abandonment of permanent access in the index extremity
timeFrame: 12 months
measure: Proportion of Subjects with Device Success
timeFrame: 12 Months
measure: Proportion of Subjects with Procedural Success
timeFrame: 12 Months
measure: Proportion of Subjects with Clinical Success
timeFrame: 12 Months
measure: Rate of device and procedure related adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH Graz
city: Le Mans
country: France
facility: Clinique du Pré
city: Melun
country: France
facility: Clinique Les Fontaines
city: Paris
country: France
facility: Institut Montsouris
city: Giessen
country: Germany
facility: Uniklinik Giessen und Marburg
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Patras
country: Greece
facility: University Hospital of Patras
city: Pisa
country: Italy
facility: Azienda Ospedaliera Di Pisa - Ospedale Cisanello
city: Pompei
country: Italy
facility: Casa Di Cura Maria Rosaria
city: Torino
country: Italy
facility: San Giovanni Bosco
city: Varese
country: Italy
facility: University of Insubria
city: Lublin
country: Poland
facility: Klinika Chirurgii Naczyniowej University Hospital nr 1
city: Lisboa
country: Portugal
facility: Hospital da Cruz Vermelha
city: Lisboa
country: Portugal
facility: NephroCare Portugal, S.A. NephroCare Lumia
city: Riyadh
country: Saudi Arabia
facility: King Abdullah International Medical Research Center
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
city: Dalin
country: Taiwan
facility: Buddhist Dalin Tzuchi hospital
city: Linkou
country: Taiwan
facility: Chang-Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: Hsin Kong Wu Ho-Su Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Tzu Chi Hospital
city: Ankara
country: Turkey
facility: Ankara Baskent University
city: Leicester
country: United Kingdom
facility: Lister Hospital
city: London
country: United Kingdom
facility: Barts and The Royal London Hospital
city: Reading
country: United Kingdom
facility: Royal Berkshire hospital
Study officials:
affiliation: University Hospital of Patras, Radiology Department
name: Dimitrios Karnabatidis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: