Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae

NCT02746159 | Completed

• 1 other identifier: CL0026-01
• Study Type: observational
• Target: 320
• Locations: 13 countries
• Sites: 26

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.

Conditions

Arteriovenous Fistula

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects with freedom from any serious adverse event(s) involving the AV access circuit

  Primary safety events include any serious adverse event(s) involving the AV access circuit

  30 days.

• Proportion of subjects with target lesion primary patency

  Defined as the interval following index procedure until clinically-driven reintervention of the target lesion or access thrombosis, through 6 months. Clinically-driven reintervention is defined as a lesion that has ≥50% stenosis and at least one clinical, physiological or hemodynamic abnormality attributable to the stenosis defined in the K/DOQI guidelines.

  6 Months

Secondary Outcomes (7)

• Proportion of subjects with access circuit primary patency at 3, 6, and 12 months

  12 months

• Proportion of Subjects withTarget Lesion Primary Patency (TLPP)

  12 months

• Proportion of Subjects with Abandonment of permanent access in the index extremity

  12 months

• Proportion of Subjects with Device Success

  12 Months

• Proportion of Subjects with Procedural Success

  12 Months

Interventions

Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004 DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male or non-pregnant, non-breastfeeding female ≥18 years of age;
• Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits;
• 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
• Lesion(s) can be treated with available Lutonix DCB device size matrix per current IFU.

You may not qualify if:

• Patients will be excluded if ANY of the following conditions apply:
• 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).
• Patient has a non-controllable allergy to contrast; or
• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (26)

LKH Graz

Graz, A-8036, Austria

Location

Clinique du Pré

Le Mans, 72018, France

Location

Clinique Les Fontaines

Melun, 77000, France

Location

Institut Montsouris

Paris, 75014, France

Location

Uniklinik Giessen und Marburg

Giessen, 35392, Germany

Location

Universitätsklinikum Jena

Jena, 07743, Germany

Location

University Hospital of Patras

Pátrai, 26504, Greece

Location

Azienda Ospedaliera Di Pisa - Ospedale Cisanello

Pisa, Italy

Location

Casa Di Cura Maria Rosaria

Pompei, 80045, Italy

Location

San Giovanni Bosco

Torino, Italy

Location

University of Insubria

Varese, 21100, Italy

Location

Klinika Chirurgii Naczyniowej University Hospital nr 1

Lublin, 20-081, Poland

Location

Hospital da Cruz Vermelha

Lisbon, 1549-008, Portugal

Location

NephroCare Portugal, S.A. NephroCare Lumia

Lisbon, 1750-130, Portugal

Location

King Abdullah International Medical Research Center

Riyadh, Saudi Arabia

Location

National University Hospital

Singapore, 119228, Singapore

Location

Singapore General Hospital

Singapore, 169856, Singapore

Location

Ospedale Regionale di Lugano

Lugano, 6903, Switzerland

Location

Buddhist Dalin Tzuchi hospital

Dalin, Taiwan

Location

Chang-Gung Memorial Hospital

Linkou District, Taiwan

Location

Hsin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Taipei Tzu Chi Hospital

Taipei, Taiwan

Location

Ankara Baskent University

Ankara, Turkey (Türkiye)

Location

Lister Hospital

Leicester, SG1 4AB, United Kingdom

Location

Barts and The Royal London Hospital

London, E1 1BB, United Kingdom

Location

Royal Berkshire hospital

Reading, RG1 5AN, United Kingdom

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dimitrios Karnabatidis, MD, PhD

  University Hospital of Patras, Radiology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 21, 2016
• Study Start: June 7, 2016
• Primary Completion: September 18, 2018
• Study Completion: March 9, 2019
• Last Updated: February 22, 2023

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4); TU (1); AU (1); SA (1); GB (3); PT (2); FR (3); DE (2); GR (1); IT (4); PL (1); SG (2); CH (1)