University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
NCT Number: NCT02324764
The objective of this study is to determine the rate of radial artery occlusion and vascular access site complications following transradial angiogram using a new Terumo (Tokyo, Japan) Glidesheath Slender, in comparison with the currently used 6 French (6 Fr.) radial sheath.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Ottawa, Ontario, K1Y 4W7, Canada
Based on previously reported studies the rates of radial artery occlusion using a standard 6 Fr. sheath is around 5-10%, compared to the single feasibility study of the Glidesheath Slender by Aminian et al (see reference in the citations), the rate of radial artery occlusion was reported 0.88%.
This study will be a prospective randomized, single-blinded (patient-blinded) study, comparing the rate of radial artery occlusion and vascular access site complications between the Glidesheath Slender (Terumo, Tokyo, Japan) and the standard 6 Fr. radial sheath in patients undergoing transradial coronary catheterization.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath.
Other names: Glidesheath Slender, Terumo, Tokyo, Japan
Time frame: 30 days
Evaluated clinically and by ultrasound
Time frame: up to 30 days
Includes: Radial artery occlusion, bleeding or hematoma, pseudoaneurysm, artery dissection, compartment syndrome of the forearm
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day
Defined as ability to finish the angiogram/PCI via the intended access site, without the need to change access site.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day
Major requiring sheath exchange or minor
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day
Scored on a scale of 1-10 scoring system
Ottawa Heart Institute Research Corporation
Other
Acronym: CAPITAL-PRO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00817349
Arterial Occlusive Disease, Arterial Occlusive Diseases
Los Angeles, California, United States
View Trial DetailsNCT03188705
Arterial Occlusive Diseases, Arteriosclerosis
Lancaster, Pennsylvania, United States
View Trial DetailsNCT07468955
Arterial Occlusive Diseases, Arteriosclerosis
Kütahya, Center, Turkey (Türkiye)
View Trial DetailsNCT05099692
Cardiac Rehabilitation, Cardiovascular Diseases
Shenyang, Liaoning, China
View Trial Details