Evaluation of STARgraft-3 for Hemodialysis (NCT05729620) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of STARgraft-3 for Hemodialysis
Paraguay21 participantsStarted 2022-11-29
Plain-language summary
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-3 hemodialysis access graft. STARgraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and infection.
This study is an extension from prior studies with STARgraft AV (NCT03916731) and STARgraft-2 (NCT04783779) investigational devices. A previous study also included control implants of commercially available standard ePTFE grafts approved for the same use.
The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to evaluate the performance of the investigational STARgraft-3 compared to the ePTFE controls in the prior study and to published results, over a period of 6 months, with extended results to 1 year.
Estimated enrollment is 15 subjects in this study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, \> 18 years or age.
✓. Patient has given informed consent to participate in the trial.
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
✓. Able to effectively communicate with study personnel.
✓. Candidate for a new arterio-venous graft placed in the upper arm.
✓. Life expectancy judged to be at least 2 years.
✓. Axillary vein of greater than or equal to 7 mm in diameter.
✓. Brachial artery of greater than or equal to 4 mm in diameter.
Exclusion criteria
✕. Unable or unlikely to comply with trial protocol and/or follow-up.