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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Arteriovenous Fistula
- Sponsor
- C. R. Bard
- Enrollment
- 320
- Locations
- 26
- Primary Endpoint
- Proportion of subjects with target lesion primary patency
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Proportion of subjects with target lesion primary patency
Time Frame: 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
Time Frame: 30 days.
Primary safety events include any serious adverse event(s) involving the AV access circuit
Secondary Outcomes
- Proportion of subjects with access circuit primary patency at 3, 6, and 12 months(12 months)
- Proportion of Subjects with Device Success(12 Months)
- Proportion of Subjects with Abandonment of permanent access in the index extremity(12 months)
- Proportion of Subjects withTarget Lesion Primary Patency (TLPP)(12 months)
- Proportion of Subjects with Procedural Success(12 Months)
- Proportion of Subjects with Clinical Success(12 Months)
- Rate of device and procedure related adverse events(12 months)