CompletedNot Applicable

DyeVert System and Contrast-induced Acute Kidney Injury

Italy522 participantsStarted 2020-02-10

Plain-language summary

The aim of the REnal Insufficiency Following Contrast MEDIA Administration TriaL IV (REMEDIAL IV) is to test whether the use of the DyeVert system is effective in reducing CI-AKI rate in ACS patients undergoing urgent/immediate (within 2 hours) invasive diagnostic and/or interventional cardiovascular procedures. The DyeVert™ system (Osprey Medical Inc., Minnetonka, MN, USA) is a novel device designed to reduce CM volume during coronary procedures, while maintaining fluoroscopic image quality. Patients with ACS scheduled for urgent/immediate coronary angiography/angioplasty will be enrolled and randomized into 2 groups: 1) DyeVert group (CM injection will be handled by the DyeVert TM system), and 2) Control group (CM injection will be carried out by a conventional manual injection syringe).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Refractory angina,
✓. Signs or symptoms of heart faiklure or new or worsening mitral regurgitation,
✓. Hemodynamic instability,
✓. Recurrent angina or ischemia at rest or with low-level activities despite intensive medical therapy,
✓. Sustained ventricular tachycardia or ventricular fibrillation,
✓. Recurrent dynamic ST-T wave changes, particularly with intermittent ST-elevation.

What they're measuring

Rate of contrast-induced Acute Kidney Injury (CI-AKI).

Timeframe: 30 days

Trial details

NCT IDNCT04714736

SponsorClinica Mediterranea

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Contrast-induced Acute Kidney Injury trials