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

Completed

• Conditions: Arteriovenous Fistula

• Registration Number: NCT02746159
• Lead Sponsor: C. R. Bard

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.

Study Timeline

• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-21
• Study Start: 2016-06-07
• Primary Completion: 2018-09-18
• Study Completion: 2019-03-09
• Status Verified: 2019-08
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with target lesion primary patency	6 Months	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.
Proportion of subjects with freedom from any serious adverse event(s) involving the AV access circuit	30 days.	Primary safety events include any serious adverse event(s) involving the AV access circuit

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with access circuit primary patency at 3, 6, and 12 months	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.
Proportion of Subjects with Device Success	12 Months	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.
Proportion of Subjects with Abandonment of permanent access in the index extremity	12 months	The arteriovenous fistula / access circuit is considered abandoned when it is no longer being used for dialysis because the access was not functioning.
Proportion of Subjects withTarget Lesion Primary Patency (TLPP)	12 months	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.
Proportion of Subjects with Procedural Success	12 Months	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).
Proportion of Subjects with Clinical Success	12 Months	The resumption of dialysis for at least one session after the index procedure.
Rate of device and procedure related adverse events	12 months	Freedom from device-related or procedure-related serious adverse events

Trial Locations

Locations (26)

LKH Graz; 🇦🇹 Graz, Austria

Clinique du Pré; 🇫🇷 Le Mans, France

Clinique Les Fontaines; 🇫🇷 Melun, France

Institut Montsouris; 🇫🇷 Paris, France

Uniklinik Giessen und Marburg; 🇩🇪 Giessen, Germany

Universitätsklinikum Jena; 🇩🇪 Jena, Germany

University Hospital of Patras; 🇬🇷 Patras, Greece

Azienda Ospedaliera Di Pisa - Ospedale Cisanello; 🇮🇹 Pisa, Italy

Casa Di Cura Maria Rosaria; 🇮🇹 Pompei, Italy

San Giovanni Bosco; 🇮🇹 Torino, Italy

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