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

Arteriovenous Fistula Clinical Trial

— AVR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746159
• Other study ID #: CL0026-01
• Status: Completed
• Start date: June 7, 2016
• Est. completion date: March 9, 2019

Study information

• Verified date: August 2019
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: March 9, 2019
• Est. primary completion date: September 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

Device:
• Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004

Locations

Country	Name	City	State
Austria	LKH Graz	Graz
France	Clinique du Pré	Le Mans
France	Clinique Les Fontaines	Melun
France	Institut Montsouris	Paris
Germany	Uniklinik Giessen und Marburg	Giessen
Germany	Universitätsklinikum Jena	Jena
Greece	University Hospital of Patras	Patras
Italy	Azienda Ospedaliera Di Pisa - Ospedale Cisanello	Pisa
Italy	Casa Di Cura Maria Rosaria	Pompei
Italy	San Giovanni Bosco	Torino
Italy	University of Insubria	Varese
Poland	Klinika Chirurgii Naczyniowej University Hospital nr 1	Lublin
Portugal	Hospital da Cruz Vermelha	Lisboa
Portugal	NephroCare Portugal, S.A. NephroCare Lumia	Lisboa
Saudi Arabia	King Abdullah International Medical Research Center	Riyadh
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Switzerland	Ospedale Regionale di Lugano	Lugano
Taiwan	Buddhist Dalin Tzuchi hospital	Dalin
Taiwan	Chang-Gung Memorial Hospital	Linkou
Taiwan	Hsin Kong Wu Ho-Su Memorial Hospital	Taipei
Taiwan	Taipei Tzu Chi Hospital	Taipei
Turkey	Ankara Baskent University	Ankara
United Kingdom	Lister Hospital	Leicester
United Kingdom	Barts and The Royal London Hospital	London
United Kingdom	Royal Berkshire hospital	Reading

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Countries where clinical trial is conducted

Austria,  France,  Germany,  Greece,  Italy,  Poland,  Portugal,  Saudi Arabia,  Singapore,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Proportion of subjects with access circuit primary patency at 3, 6, and 12 months	Interval following intervention until the next access circuit thrombosis or repeated intervention. Ends with treatment of a lesion anywhere within the access circuit.	12 months
Secondary	Proportion of Subjects withTarget Lesion Primary Patency (TLPP)	Target Lesion Primary Patency (TLPP) is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.	12 months
Secondary	Proportion of Subjects with Abandonment of permanent access in the index extremity	The arteriovenous fistula / access circuit is considered abandoned when it is no longer being used for dialysis because the access was not functioning.	12 months
Secondary	Proportion of Subjects with Device Success	Successful delivery to the target lesion, deployment, and retrieval at index procedure. If a device is inserted into the subject but not used due to user error (e.g. inappropriate balloon length or transit time too long), this device will not be included in the device success assessment.	12 Months
Secondary	Proportion of Subjects with Procedural Success	At least one indicator of hemodynamic success (e.g., physical examination with restoration of a thrill, direct measurement of flow) in the absence of peri-procedural (index procedure and through hospital stay) Serious Adverse Device Effects (SADEs).	12 Months
Secondary	Proportion of Subjects with Clinical Success	The resumption of dialysis for at least one session after the index procedure.	12 Months
Secondary	Rate of device and procedure related adverse events	Freedom from device-related or procedure-related serious adverse events	12 months