Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arte… (NCT03506308) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae
United States213 participantsStarted 2018-08-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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;
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
What they're measuring
1
Percentage of Participants With Target Lesion Primary Patency (TLPP)
Timeframe: 6 Months
2
Percentage of Participants With No Primary Safety Events