Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae

Arteriovenous Fistula Clinical Trial

— AVPAS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03506308
• Other study ID #: CL0033-01
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: September 2029

Study information

• Verified date: February 2024
• Source: C. R. Bard
• Contact: Bradley Forsyth, MBA
• Phone: 385-583-9259
• Email: bradley.forsyth[@]bd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 213
• Est. completion date: September 2029
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

Device:
• LUTONIX 035 Drug Coated Balloon PTA Catheter
All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

Locations

Country	Name	City	State
Canada	William Osler Health System/Brampton Civic Hospital	Brampton	Ontario
Canada	Centre hospitalier de l'Université de Montreal	Montréal	Quebec
Canada	Scarborough Health Network	Scarborough	Ontario
Canada	University Health Network	Toronto	Ontario
United States	University of Michigan	Ann Arbor	Michigan
United States	MedStar Health Research Institute	Annapolis	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dallas Vascular Center	Dallas	Texas
United States	Flowers Hospital	Dothan	Alabama
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	HCA Houston Healthcare	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	University of Texas Health Science Center	Houston	Texas
United States	University of Iowa Hospital and Clinics	Iowa City	Iowa
United States	University of Louisville	Louisville	Kentucky
United States	University of Minnesota	Minneapolis	Minnesota
United States	Yale University	New Haven	Connecticut
United States	Ochsner Health System	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Sentara Medical Group	Norfolk	Virginia
United States	St. Joseph Hospital of Orange	Orange	California
United States	Rochester General Hospital	Rochester	New York
United States	Kaiser Permanente	San Diego	California
United States	Ochsner Louisiana State University Health	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vital status of participants	All cause death	36, 48, and 60 Months
Primary	Percentage of Participants With Target Lesion Primary Patency (TLPP)	TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.	6 Months
Primary	Percentage of Participants With No Primary Safety Events	Primary safety events include any serious adverse event(s) involving the AV access circuit through 30 days	30 days
Secondary	Percentage of Participants With 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.	12, 18, 24 Months
Secondary	Number of re-interventions required to maintain target lesion patency	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.	6, 12, 18, 24 Months
Secondary	Percentage of Participants With Access Circuit Primary Patency (ACPP)	Access circuit is defined as the area from the AV access anastomosis to the superior vena cava-right atrial junction.	6, 12, 18, 24 Months
Secondary	Number of re-interventions required to maintain access circuit patency	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.	6, 12, 18, 24 Months
Secondary	Percentage of Participants With Device, Procedural, and Clinical Success	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.	24 Months
Secondary	Percentage of Participants With Abandonment of Permanent Access in the Index Extremity	The arteriovenous fistula / access circuit is considered abandoned when it is no longer being used for dialysis because the access was not functioning.	6, 12, 18, 24 Months
Secondary	Percentage of Participants With Secondary Patency of the Access Circuit	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.	6, 12, 18, 24 Months
Secondary	Time to loss of target lesion secondary patency following DCB intervention	Time between first reintervention with the DCB to the next loss of patency	24 Months
Secondary	Percentage of Participants With Freedom from any Serious Adverse Event(s) Involving the AV Access Circuit	Safety events include any serious adverse event(s) involving the AV access circuit	6, 12, 18, 24 Months
Secondary	Percentage of Participants With Device and Procedure Related Adverse Events	Freedom from device-related or procedure-related serious adverse events	6, 12, 18, 24 Months