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Radial Artery OcclusionNCT04748068

Use of Glidesheath Slender to Reduce Radial Artery Occlusion Following 7 French Transradial Coronary Intervention

A study testing 7-Fr Glidesheath Slender and Cordis 7-Fr radial sheath in people with Radial Artery Occlusion and Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to determine the rate of early radial artery occlusion following 7-French(7-Fr) transradial coronary intervention using a new Terumo (Tokyo, Japan) Glidesheath Slender, in comparison with the currently used 7-Fr radial sheath. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
7-Fr Glidesheath Slender and Cordis 7-Fr radial sheath
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteChina
Study dates
1 Feb 2021to 31 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing coronary PCI via 7-Fr transradial approach
  • Informed consent
  • the patency of radial artery confirmed by ultrasound

Who cannot join

  • The abnormal of radial artery confirmed by ultrasound
  • Previous failed radial access.
  • Known bleeding disorder or hypercoagulable condition
  • Cardiogenic shock

Trial locations and contacts

1 site in 1 country.

Hao Wang, MD,PhD contact

+86-15701277767

wanghao_fuwai@126.com

China1 site

  • Fuwai Hospital National Center for Cardiovascular Diseases

    Beijing, Beijing Municipality, 100037

    Hao Wang, MD,PhD, +86-15701277767, wanghao_fuwai@126.com

    Kefei Dou, MD,PhD

Other trials in China

About this study

The objective of this study is to determine the rate of early radial artery occlusion following 7-French(7-Fr) transradial coronary intervention using a new Terumo (Tokyo, Japan) Glidesheath Slender, in comparison with the currently used 7-Fr radial sheath.

Read the 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.

Being tested
7-Fr Glidesheath Slender, Cordis 7-Fr radial sheath
Keywords
Radial artery occlusion, 7-Fr radial sheath, Transradial Coronary Intervention
Medical subject headings
Arterial Occlusive Diseases, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 7-Fr Glidesheath SlenderDevice

    Also called Glidesheath Slender, Terumo, Tokyo, Japan

    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

  • Cordis 7-Fr radial sheathDevice

    Avanti+ Catheter Sheath Introducer, Cordis, USA, outer diameter: 3.02 mm

Study groups in NCT04748068
Study groupRoleWhat they receive
Glidesheath SlenderExperimentalThe transradial procedure will be performed using the 7-Fr glidesheath slender (studied sheath)
Receives: Device: 7-Fr Glidesheath Slender
Standard sheathActive comparatorThe transradial procedure will be performed using the standard 7- French radial sheath (comparator sheath)
Receives: Device: Cordis 7-Fr radial sheath

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radial artery occlusion

    Evaluated clinically and by ultrasound

    Measured: 24 hours

Secondary outcomes (4)

  1. Vascular access site complications

    Includes: bleeding or hematoma, pseudoaneurysm, artery dissection, arteriovenous fistula, compartment syndrome of the forearm

    Measured: 24 hours

  2. Radial artery spasm

    Radial artery spasm

    Measured: 24 hours

  3. Procedure success

    completion of the planned procedure through the initially selected radial access route

    Measured: 24 hours

  4. The degree of pain at the puncture site

    Scored on a scale of 1-10 scoring system

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2021
  2. Study start1 Feb 2021 (estimated)
  3. Primary completion31 May 2021 (estimated)
  4. Study completion31 May 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04748068
Sponsor's protocol ID
7F Glidesheath Slender
Status last verified
Feb 2021
First submitted
25 Jan 2021
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 26811162

  • 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.

    PubMed 31753298

  • 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.

    PubMed 27567021

  • 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.

    PubMed 32863791

  • 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.

    PubMed 10348538

  • 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.

    PubMed 26839392

  • Wang H, Wang HY, Wu SY, Yin D, Feng L, Song WH, Wang HJ, Zhu CG, Dou KF. Effect of Thin-Walled Radial Sheath for Large-Bore Access On Reducing Periprocedural Radial Artery Occlusion Following Complex PCI: The REDUCE-RAO Randomized Trial. Rev Cardiovasc Med. 2022 Sep 28;23(10):329. doi: 10.31083/j.rcm2310329. eCollection 2022 Oct.

    PubMed 39077135

Questions about this trial

What is this clinical trial studying?

A study testing 7-Fr Glidesheath Slender and Cordis 7-Fr radial sheath in people with Radial Artery Occlusion and Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hao Wang, MD,PhD (+86-15701277767, wanghao_fuwai@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radial artery occlusion (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04748068, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.

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