- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04748068
Use of Glidesheath Slender to Reduce Radial Artery Occlusion Following 7 French Transradial Coronary Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Based on previously reported studies the rates of radial artery occlusion using a standard 7-Fr sheath is around 12%, compared to the previous studies of the Glidesheath Slender (see reference in the citations), the rate of radial artery occlusion was reported less than 5%. To prove Slender sheaths are superior to traditional ones, the sample size was estimated according to this, the class I error (α) is set as 0.05 on both sides, and the test efficiency (β) is set as 80%, then at least 248 patients are needed in each group.
This study will be a prospective randomized, single-blinded (patient-blinded) study, comparing the rate of radial artery occlusion between the 7-Fr Glidesheath Slender (Terumo, Japan) and the standard 7-Fr radial sheath (cordis, USA) in patients undergoing complex transradial coronary intervention.
The study will enroll patients who will undergo elective complex percutaneous coronary intervention (PCI) via 7-Fr transradial approach at Fuwai Hospital National Center for Cardiovascular Diseases.
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 7-Fr Terumo Glidesheath Slender versus the currently used 7-Fr sheath.
The standard angiogram/ PCI will be performed as per usual practice. Following the PCI, clinical vascular assessment as well as an ultrasound will be performed prior to discharge.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100037
- Fuwai Hospital National Center for Cardiovascular Diseases
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients undergoing coronary PCI via 7-Fr transradial approach
- Informed consent
- the patency of radial artery confirmed by ultrasound
Exclusion Criteria:
- The abnormal of radial artery confirmed by ultrasound
- Previous failed radial access.
- Known bleeding disorder or hypercoagulable condition
- Cardiogenic shock
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Glidesheath Slender
The transradial procedure will be performed using the 7-Fr glidesheath slender (studied sheath)
|
The 7 Fr Glidesheath Slender is a recently developed thin-walled radial sheath.
It combines an ID of 2.46 mm, with an OD of 2.79 mm, representing thereby the thinnest 7 Fr sheath currently available on the market
Other Names:
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ACTIVE_COMPARATOR: Standard sheath
The transradial procedure will be performed using the standard 7- French radial sheath (comparator sheath)
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Avanti+ Catheter Sheath Introducer, Cordis, USA, outer diameter: 3.02 mm
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radial artery occlusion
Time Frame: 24 hours
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Evaluated clinically and by ultrasound
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vascular access site complications
Time Frame: 24 hours
|
Includes: bleeding or hematoma, pseudoaneurysm, artery dissection, arteriovenous fistula, compartment syndrome of the forearm
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24 hours
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Radial artery spasm
Time Frame: 24 hours
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Radial artery spasm
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24 hours
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Procedure success
Time Frame: 24 hours
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completion of the planned procedure through the initially selected radial access route
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24 hours
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The degree of pain at the puncture site
Time Frame: 24 hours
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Scored on a scale of 1-10 scoring system
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24 hours
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Collaborators and Investigators
Investigators
- Principal Investigator: Kefei Dou, MD,PhD, Fuwai Hospital National Center for Cardiovascular Diseases
- Principal Investigator: Chenggang Zhu, MD,PhD, Fuwai Hospital National Center for Cardiovascular Diseases
Publications and helpful links
General Publications
- Rashid M, Kwok CS, Pancholy S, Chugh S, Kedev SA, Bernat I, Ratib K, Large A, Fraser D, Nolan J, Mamas MA. Radial Artery Occlusion After Transradial Interventions: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2016 Jan 25;5(1):e002686. doi: 10.1161/JAHA.115.002686.
- Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, Gilchrist IC, Saito S, Hahalis GN, Ziakas A, Louvard Y, Montalescot G, Sgueglia GA, van Leeuwen MAH, Babunashvili AM, Valgimigli M, Rao SV, Bertrand OF; RAO International Group. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2235-2246. doi: 10.1016/j.jcin.2019.07.043.
- Aminian A, Iglesias JF, Van Mieghem C, Zuffi A, Ferrara A, Manih R, Dolatabadi D, Lalmand J, Saito S. First prospective multicenter experience with the 7 French Glidesheath slender for complex transradial coronary interventions. Catheter Cardiovasc Interv. 2017 May;89(6):1014-1020. doi: 10.1002/ccd.26773. Epub 2016 Aug 27.
- Isawa T, Horie K, Honda T, Taguri M, Tada N. Slender Sheath/Guiding Catheter Combination vs. Sheathless Guiding Catheter for Acute Coronary Syndrome: A Propensity-Matched Analysis of the Two Devices. J Interv Cardiol. 2020 Aug 14;2020:8216831. doi: 10.1155/2020/8216831. eCollection 2020. Erratum In: J Interv Cardiol. 2020 Oct 22;2020:1303764.
- Saito S, Ikei H, Hosokawa G, Tanaka S. Influence of the ratio between radial artery inner diameter and sheath outer diameter on radial artery flow after transradial coronary intervention. Catheter Cardiovasc Interv. 1999 Feb;46(2):173-8. doi: 10.1002/(SICI)1522-726X(199902)46:23.0.CO;2-4.
- Costa F, van Leeuwen MA, Daemen J, Diletti R, Kauer F, van Geuns RJ, Ligthart J, Witberg K, Zijlstra F, Valgimigli M, Van Mieghem NM. The Rotterdam Radial Access Research: Ultrasound-Based Radial Artery Evaluation for Diagnostic and Therapeutic Coronary Procedures. Circ Cardiovasc Interv. 2016 Feb;9(2):e003129. doi: 10.1161/CIRCINTERVENTIONS.115.003129.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7F Glidesheath Slender
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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