GRADIENT

GRADIENT is a randomized, controlled, open label, pivotal study of the JuxtaFlow RAD among patients with renal insufficiency (eGFR 15-60) undergoing cardiac surgery with cardiopulmonary bypass. 123 patients will be randomized 2-1 to treatment versus standard of care to determine if the JuxtaFlow RAD can sustain or enhance kidney function in this patient population during and immediately following cardiac surgery. The GRADIENT clinical trial will be conducted in both the US and Europe. For additional information, please contact Elicia Dellinger at edellinger@rqmplus.com.

BIPASS-AKI

NCT05990660

A completed single arm human feasibility study. Ten patients with renal impairment (eGFR 15-60) undergoing elective cardiac surgery with cardiopulmonary bypass were enrolled across three sites in Eastern Europe.

VOID-HF

NCT04227977

A completed double cross-over design human feasibility study. Seven patients presenting to the hospital with acute decompensated heart failure who did not adequately respond to high dose iv loop diuretics were enrolled in the US.

A porcine study of mock cardiac surgery using a parallel group design. Eight animals underwent baseline, surgery and recovery comparing the JuxtaFlow RAD to no treatment.

A porcine study of a model of wet-warm heart failure using a parallel group design. Ten animals were randomized to the JuxtFlow RAD or no treatment.

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