DyeVert System RCT

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the amount of contrast media (CM) saved using the DyeVert system in diagnostic angiographic procedures compared to a control group.

Clinical Trial Description

This is a prospective, randomized, parallel group, single center clinical evaluation of the DyeVert System. Subjects undergoing a diagnostic coronary angiogram procedure with a 5 French catheter are eligible to participate in this study. The treatment group will use the DyeVert System.

The trial will be conducted at one center, located in Germany. A sample size of 96 evaluable subjects will provide a sufficient number of samples to evaluate the primary objectives.

Randomization will occur following confirmation that the subject meets the inclusion/exclusion criteria and has signed an informed consent. Subjects that are anticipated to be a diagnostic only procedure, but end up being an ad-hoc PCI, can still remain enrolled in the trial. If a subject proceeds to a PCI, data will only be collected through the diagnostic portion of the case. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Coronary Angiography

Clinical Trial Details

NCT number	NCT02752802
Study type	Interventional
Source	Osprey Medical, Inc
Contact
Status	Completed
Phase	N/A
Start date	April 2016
Completion date	May 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01239225` - Prevalence of Abdominal Aortic Aneurysm in Patients Undergoing Coronary Angiography	Phase 4
Recruiting	`NCT05075590` - Coronary Access After Supra-Annular THV Implantation	N/A
Completed	`NCT02606734` - DyeVert Pilot Trial	N/A
Completed	`NCT00632918` - Effects of Heart Rates and Variability of Heart Rates on Image Quality of Dual-Source CT Coronary Angiography	N/A
Completed	`NCT04801901` - Distal Transradial Access for Percutaneous Coronary Intervention	N/A
Completed	`NCT00345501` - Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients Undergoing Coronary Angiography and/or Intervention	Phase 2/Phase 3
Recruiting	`NCT04521660` - The Effect of Using Virtual Reality Glasses During Coronary Angiography	N/A
Completed	`NCT05982366` - Feasibility and Safety of the Routine Distal Transradial Approach	N/A
Recruiting	`NCT04982419` - Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial	Phase 2/Phase 3
Completed	`NCT00468195` - Optimizing Image Quality in Obese Patients Undergoing Coronary Computed Tomography (CT) Angiography	N/A
Completed	`NCT00468325` - Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT)	N/A
Completed	`NCT04911218` - GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery	N/A
Completed	`NCT04318990` - DIstal vs Proximal Radial Artery Access for Cath	N/A
Recruiting	`NCT06312397` - The Effect on Back Pain and Fatigue Level of Acupressure	N/A
Recruiting	`NCT05319119` - Fractional Flow Reserve Derived From CT Related Treatment
Not yet recruiting	`NCT05133206` - Fasting or Non-fasting Before Cardiac Catheterization	N/A
Completed	`NCT02818101` - Hypnosis Efficacy for the Prevention of Anxiety During a Coronary Angiography	N/A
Completed	`NCT00465335` - Usefulness of Coronary CT Angiography in Patients With Inconclusive Stress Test Results	N/A
Recruiting	`NCT06035783` - Calcium Reduction by Orbital Atherectomy in Western Europe
Completed	`NCT04407936` - Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention