Arteriovenous Fistula
Conditions
Brief summary
This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.
Detailed description
This post-market approval study (PAS) is required by the FDA as a condition of approval for the Lutonix drug coated balloon catheter. It is intended to demonstrate safety and assess the clinical use and outcomes of the LUTONIX Catheter in dysfunctional arteriovenous fistulae (AVF) in a heterogeneous patient population in real world clinical practice.
Interventions
DEVICELUTONIX 035 Drug Coated Balloon PTA Catheter
All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or non-pregnant, non-breastfeeding female ≥18 years of age 2. Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits 3. Target lesion must be a mature arteriovenous fistula located in the arm presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines 4. Subject has a target lesion that can be treated with available LUTONIX DCB according to the Instructions For Use (IFU) 5. Venous stenosis of an AV fistula in which the target lesion is located from the anastomosis to the axillosubclavian junction, as defined by insertion of the cephalic vein 6. Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon defined as: 1. No clinically significant dissection; 2. No extravasation requiring treatment; 3. Residual stenosis ≤30% by angiographic measurement; 4. Ability to completely efface the waist using the pre-dilation balloon.
Exclusion criteria
1. Subject is currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study 2. Subject has a non-controllable allergy to contrast 3. Subject has another medical condition that, in the opinion of the Investigator, may confound the data interpretation or is associated with a life expectancy insufficient to allow for completion of subject study procedure and follow up 4. Target lesion is located central to the axillosubclavian junction 5. A thrombosed access or an access with a thrombosis treated ≤7 days before to the index procedure 6. Prior surgical interventions of the access site ≤30 days before the index procedure 7. Target lesion is located within a bare metal or covered stent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Target Lesion Primary Patency (TLPP) | 6 Months | TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. |
| Percentage of Participants With No Primary Safety Events | 30 days | Primary safety events include any serious adverse event(s) involving the AV access circuit through 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Target Lesion Primary Patency | 12, 18, 24 Months | TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. |
| Number of re-interventions required to maintain target lesion patency | 6, 12, 18, 24 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. |
| Percentage of Participants With Access Circuit Primary Patency (ACPP) | 6, 12, 18, 24 Months | Access circuit is defined as the area from the AV access anastomosis to the superior vena cava-right atrial junction. |
| Number of re-interventions required to maintain access circuit patency | 6, 12, 18, 24 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. |
| Percentage of Participants With Device, Procedural, and Clinical Success | 24 Months | Device Success: Successful delivery to the target lesion, deployment, and retrieval at index procedure. 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). Clinical Success: The resumption of dialysis for at least one session after the index procedure. |
| Percentage of Participants With Abandonment of Permanent Access in the Index Extremity | 6, 12, 18, 24 Months | The arteriovenous fistula / access circuit is considered abandoned when it is no longer being used for dialysis because the access was not functioning. |
| Percentage of Participants With Secondary Patency of the Access Circuit | 6, 12, 18, 24 Months | Survival of patency of access circuit from the time of intervention until access abandonment or achievement of a censored event (death, transfer to another hemodialysis unit, transfer to peritoneal dialysis, transplantation, and end of study period), and includes all surgical and endovascular interventions. |
| Time to loss of target lesion secondary patency following DCB intervention | 24 Months | Time between first reintervention with the DCB to the next loss of patency |
| Percentage of Participants With Freedom from any Serious Adverse Event(s) Involving the AV Access Circuit | 6, 12, 18, 24 Months | Safety events include any serious adverse event(s) involving the AV access circuit |
| Percentage of Participants With Device and Procedure Related Adverse Events | 6, 12, 18, 24 Months | Freedom from device-related or procedure-related serious adverse events |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORScott Trerotola, MD
Hospital of the University of Pennsylvania; Division of Interventional Radiology
PRINCIPAL_INVESTIGATORDheeraj Rajan, MD
University Health Network; Division of Vascular & Interventional Radiology
Outcome results
None listed