Use of Glidesheath Slender to Reduce Radial Artery Occlusion and Vascular Access Site Complications Following Transradial Coronary Angiography (CAPITAL-PRO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02324764|
Recruitment Status : Recruiting
First Posted : December 24, 2014
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Embolism and Thrombosis of the Radial Artery Coronary Heart Disease||Device: Glidesheath Slender Device: standard 6- French radial sheath||Not Applicable|
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.
- The study will enroll patients who will undergo elective or emergency coronary angiography and/or percutaneous coronary intervention (PCI) via transradial approach at the University of Ottawa Heart Institute.
- A baseline clinical vascular & ultrasound assessment will be performed prior to the procedure to document patency of the radial artery.
- Patients will be randomized in 1:1 fashion to either receive the Terumo Glidesheath Slender versus the currently used 6 Fr. sheath.
- The standard angiogram/ PCI will be performed as per usual practice.
- Following the angiogram, clinical vascular assessment as well as an ultrasound will be performed prior to discharge.
- At 30 days follow up the patient will come back for clinical and ultrasound assessment of radial artery patency and access site vascular complications.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Use of Glidesheath Slender to Reduce Radial Artery Occlusion and Vascular Access Site Complications Following Transradial Coronary Angiography|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Glidesheath Slender
The transradial procedure will be performed using the glidesheath slender (studied sheath)
Device: Glidesheath Slender
testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath.
Other Name: Glidesheath Slender, Terumo, Tokyo, Japan
Active Comparator: Standard sheath
The transradial procedure will be performed using the standard 6- French radial sheath (comparator sheath)
Device: standard 6- French radial sheath
- Radial artery occlusion [ Time Frame: 30 days ]Evaluated clinically and by ultrasound
- Vascular access site complications [ Time Frame: up to 30 days ]Includes: Radial artery occlusion, bleeding or hematoma, pseudoaneurysm, artery dissection, compartment syndrome of the forearm
- Radial artery spasm [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 day ]
- Procedure success [ 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.
- Sheath kinking [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 day ]Major requiring sheath exchange or minor
- Painful sheath removal [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324764
|Contact: Aun-Yeong Chong, MRCP, MD||613 6967000 ext firstname.lastname@example.org|
|Contact: Colleen Chilton||613 6967000 ext email@example.com|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Contact: Colleen Chilton +1 613 6967000 ext 14646 firstname.lastname@example.org|
|Contact: Lyne Stuewe +1613 6967000 ext 14646 email@example.com|
|Principal Investigator:||Aun-Yeong Chong, MRCP, MD||University of Ottawa Heart Institute Research Corporation|