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

C. R. Bard

Status: Completed

Conditions: Arteriovenous Fistula

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02746159

CL0026-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.