Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae (AVPAS)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03506308 |
|
Recruitment Status :
Recruiting
First Posted : April 24, 2018
Last Update Posted : May 2, 2022
|
Sponsor:
C. R. Bard
Information provided by (Responsible Party):
C. R. Bard
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Arteriovenous Fistula | Device: LUTONIX 035 Drug Coated Balloon PTA Catheter | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 213 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective, Global, Multicenter, Single Arm Post-Approval Study Investigating the Clinical Use and Safety of the Lutonix® Drug Coated Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae |
| Actual Study Start Date : | August 7, 2018 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | June 2027 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
LUTONIX 035 Drug Coated Balloon PTA Catheter
This is a single-arm study. All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
|
Device: LUTONIX 035 Drug Coated Balloon PTA Catheter
All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter. |
Primary Outcome Measures :
- Percentage of Participants With Target Lesion Primary Patency (TLPP) [ Time Frame: 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 [ Time Frame: 30 days ]Primary safety events include any serious adverse event(s) involving the AV access circuit through 30 days
Secondary Outcome Measures :
- Percentage of Participants With Target Lesion Primary Patency [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6, 12, 18, 24 Months ]Freedom from device-related or procedure-related serious adverse events
Other Outcome Measures:
- Vital status of participants [ Time Frame: 36, 48, and 60 Months ]All cause death
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or non-pregnant, non-breastfeeding female ≥18 years of age
- Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits
- 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
- Subject has a target lesion that can be treated with available LUTONIX DCB according to the Instructions For Use (IFU)
- 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
-
Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon defined as:
- No clinically significant dissection;
- No extravasation requiring treatment;
- Residual stenosis ≤30% by angiographic measurement;
- Ability to completely efface the waist using the pre-dilation balloon.
Exclusion Criteria:
- Subject is currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study
- Subject has a non-controllable allergy to contrast
- 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
- Target lesion is located central to the axillosubclavian junction
- A thrombosed access or an access with a thrombosis treated ≤7 days before to the index procedure
- Prior surgical interventions of the access site ≤30 days before the index procedure
- Target lesion is located within a bare metal or covered stent
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506308
Contacts
| Contact: Kirti Sawant | 737-414-3363 | kirti.sawant@bd.com | |
| Contact: Anna Lovas | (763) 445-2385 | anna.lovas@bd.com |
Locations
Show 18 study locations
Sponsors and Collaborators
C. R. Bard
Investigators
| Principal Investigator: | Scott Trerotola, MD | Hospital of the University of Pennsylvania; Division of Interventional Radiology | |
| Principal Investigator: | Dheeraj Rajan, MD | University Health Network; Division of Vascular & Interventional Radiology |
| Responsible Party: | C. R. Bard |
| ClinicalTrials.gov Identifier: | NCT03506308 |
| Other Study ID Numbers: |
CL0033-01 |
| First Posted: | April 24, 2018 Key Record Dates |
| Last Update Posted: | May 2, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | Yes |
Additional relevant MeSH terms:
|
Arteriovenous Fistula Fistula Pathological Conditions, Anatomical Arteriovenous Malformations Vascular Malformations |
Cardiovascular Abnormalities Cardiovascular Diseases Vascular Fistula Vascular Diseases Congenital Abnormalities |