CompletedNot Applicable

Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae

Austria, France, Germany320 participantsStarted 2016-06-07

Plain-language summary

The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and followed clinically for a minimum of 12 months.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or non-pregnant, non-breastfeeding female ≥18 years of age;
✓. Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits;
✓. Native or synthetic (grafts) arteriovenous fistula located in the arm, including central veins, presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines; and
✓. Lesion(s) can be treated with available Lutonix DCB device size matrix per current IFU.

Exclusion criteria

✕. Patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. Lutonix Global AV registry).
✕. Patient has a non-controllable allergy to contrast; or
✕. Patient has another medical condition that, which in the opinion of the Investigator, may confound the data interpretation of is associated with a life expectancy insufficient to allow for completion of patient registry procedure and follow up.

What they're measuring

Proportion of subjects with freedom from any serious adverse event(s) involving the AV access circuit

Timeframe: 30 days.

Proportion of subjects with target lesion primary patency

Timeframe: 6 Months

Trial details

NCT IDNCT02746159

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-09-18

View on ClinicalTrials.gov More Arteriovenous Fistula trials