CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 522 enrolled
Drug / intervention
Coronary angiography using DyeVert system +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04714736
NCT04714736N/ACompleted

Renal Insufficiency Following Contrast Media Administration Trial IV: Contrast Media Volume Control for Limiting Contrast-Induced Acute Kidney in Acute Coronary Syndrome.

Clinica Mediterranea·interventional·Posted Jan 19, 2021·Updated Mar 5, 2024

In Brief

A clinical study evaluating Coronary angiography using DyeVert system and Coronary angiography using conventional manual injection syringe. for Contrast-induced Acute Kidney Injury and Acute Coronary Syndromes. Completed, enrolled 522 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 19, 2021
Enrollment StartFeb 10, 2020
Primary CompletionDec 31, 2022
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.5 years ago

Interventions

Coronary angiography using DyeVert systemdevice

Invasive diagnostic and/or interventional cardiovascular procedures in the setting of acute coronary syndrome using DyeVert system.

Coronary angiography using conventional manual injection syringe.procedure

Invasive diagnostic and/or interventional cardiovascular procedures in the setting of acute coronary syndrome using conventional manual injection syringe.