Phase 3 N=285 Randomized Single-blind Treatment

Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae

Arteriovenous Fistula

Bottom Line

View on ClinicalTrials.gov: NCT02440022 ↗

Enrolled (actual)

285

Serious AEs

83.5%

Results posted

May 2020

Primary outcome: Primary: Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure — 71.4; 63 Percentage of Participants — p=0.0562

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Lutonix DCB (Combination_product); Standard Balloon Angioplasty Catheter (Device); Percutaneous Transluminal Angiography (Procedure)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: C. R. Bard
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure	71.4; 63	0.0562
PRIMARY Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure.	130; 138	0.002 sig
SECONDARY Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months	92.6; 86.7; 58; 46.4; 44.4; 36	—
SECONDARY Percentage of Participants With Device, Procedural and Clinical Success	100; 100; 97.9; 99.3; 99.3; 100	—
SECONDARY Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure	3; 0; 5; 1; 12; 4	—
SECONDARY Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure	21; 20; 68; 78; 115; 126	—
SECONDARY Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated)	5; 1; 7; 2; 7; 2	—
SECONDARY Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure	57; 48; 32; 40	0.7160
SECONDARY Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure	19; 11; 44; 64; 66; 93	—
SECONDARY Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure	8; 2; 11; 3; 11; 4	—

Summary

This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

Eligibility Criteria

Inclusion Criteria

Age ≥21 years;
The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF);
Arteriovenous fistula located in the arm;
Native AV fistula was created ≥30 days prior to the index procedure and has undergone one or more hemodialysis sessions;
Venous stenosis of an AV fistula with the target lesion located from the anastomosis to the axillosubclavian junction and an abnormality attributable to the stenosis as defined by K/DOQI guidelines.;
Successful pre-dilation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon;
Intended target lesion.

Exclusion Criteria

Women who are pregnant, lactating, or planning on becoming pregnant during the study;
Hemodialysis access is located in the leg;
Subject has more than two lesions in the access circuit;
Subject has a secondary non-target lesion that cannot be successfully treated;
Target lesion is located central to the axillosubclavian junction;
The subject has a secondary lesion located in the central venous system (central to the axillosubclavian junction);
A thrombosed access;
Surgical revision of the access site planned;
Recent prior surgical interventions of the access site;
Other planned treatment during the index procedure;
Known contraindication (including allergic reaction) or sensitivity to iodinated contrast media, that cannot be adequately managed with pre-and post-procedure medication;
Known contraindication (including allergic reaction) or sensitivity to paclitaxel.
Subjects who are taking immunosuppressive therapy or are routinely taking

≥10mg of prednisone per day;

Subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be noncompliant with the protocol or confound the data interpretation;
Subject has a life expectancy <12 months;
Anticipated for a kidney transplant;
Anticipated conversion to peritoneal dialysis;
Subject has a stent located in the target or secondary non target lesion;
Subject has an infected AV access or systemic infection;
Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02440022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.