Overview

This trial is active, not recruiting.

Condition arteriovenous fistula
Treatments lutonix dcb, standard balloon angioplasty catheter
Phase phase 3
Sponsor C. R. Bard
Start date June 2015
End date September 2016
Trial size 285 participants
Trial identifier NCT02440022, CL0023-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
PTA will be performed using the Lutonix AV drug coated balloon.
lutonix dcb
(Active Comparator)
PTA will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
standard balloon angioplasty catheter

Primary Outcomes

Measure
Efficacy: Primary Patency
time frame: 6 months
Safety: Freedom from any serious adverse event(s) involving the AV access circuit.
time frame: 30 days

Secondary Outcomes

Measure
Target Lesion Primary Patency
time frame: 12 months
Number of interventions, required to maintain target lesion patency
time frame: 12 months
Access Circuit Primary Patency
time frame: 6 months
Access Circuit Primary Patency
time frame: 12 months
Target Lesion Primary Patency
time frame: 3, 9, 18 and 24 months
Access Circuit Primary Patency
time frame: 3, 9, 18 and 24 months
Device, Procedural and Clinical Success
time frame: 24 months
Abandonment of permanent access in the index extremity
time frame: 3, 6, 9, 12, 18 and 24 months
Number of interventions, required to maintain access circuit patency
time frame: 3, 6, 9, 12, 18 and 24 months
Number of interventions, required to maintain target lesion patency
time frame: 3, 6, 9, 18 and 24 months
Rate of device and procedure related adverse events
time frame: 1, 3, 6, 9, 12, 18 and 24 months

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: 1. Age ≥21 years; 2. 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); 3. Arteriovenous fistula located in the arm; 4. Native AV fistula was created ≥30 days prior to the index procedure and has undergone one or more hemodialysis sessions; 5. 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.; 6. Successful pre-dilation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon; 7. Intended target lesion or if a tandem lesion can be treated with ≤120 mm of DCBs in length. Exclusion Criteria: 1. Women who are pregnant, lactating, or planning on becoming pregnant during the study; 2. Hemodialysis access is located in the leg; 3. Subject has more than two lesions in the access circuit; 4. Subject has a secondary non-target lesion that cannot be successfully treated; 5. Target lesion is located central to the axillosubclavian junction; 6. The subject has a secondary lesion located in the central venous system (central to the axillosubclavian junction); 7. A thrombosed access; 8. Surgical revision of the access site planned; 9. Recent prior surgical interventions of the access site; 10. Known contraindication (including allergic reaction) or sensitivity to iodinated contrast media, that cannot be adequately managed with pre-and post-procedure medication; 11. Known contraindication (including allergic reaction) or sensitivity to paclitaxel. 12. Subjects who are taking immunosuppressive therapy or are routinely taking ≥10mg of prednisone per day; 13. 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; 14. Subject has a life expectancy <12 months; 15. Anticipated for a kidney transplant; 16. Anticipated conversion to peritoneal dialysis; 17. Subject has a stent located in the target or secondary non target lesion; 18. Subject has an infected AV access or systemic infection; 19. Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study.

Additional Information

Official title A Prospective, Global, Multicenter, Randomized, Controlled Study Comparing Lutonix® 035 AV Drug Coated Balloon PTA Catheter vs. Standard Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae
Principal investigator Scott Trerotola, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by C. R. Bard.