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

Recruiting

This post-market approval study (PAS) is a prospective, multi-center, single-arm study 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. The study will include approximately 213 subjects across 30 U.S. and international sites. The LUTONIX® Catheter was approved by FDA on August 25, 2017 (PMA P170003) for the indication of percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of stenotic lesions in dysfunctional arteriovenous dialysis fistulae that are 4 mm to 12 mm in diameter and up to 80 mm in length. The study involves no intervention and all medical procedures are standard of care and not research. Follow-up information will be obtained at 6, 12, 18, and 24 months after the index procedure, and vital status will be assessed at 36, 48, and 60 months.

I'm interested

All
18 Years and over
This study is NOT accepting healthy volunteers
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

Device: LUTONIX 035 Drug Coated Balloon PTA Catheter

Arteriovenous Fistula

sfinder@umn.edu
N/A
NCT03506308
See this study on ClinicalTrials.gov

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