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AzTrials

Coronary Artery DiseaseSMARTNCT05501925

GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Distal Radial Artery Occlusion (SMART)

A study testing GlideSheath Slender® and conventional arterial sheath and Conventional arterial sheath in people with Coronary Artery Disease and Cardiovascular Diseases, run by Wujin People's Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Compared with conventional artery sheath (TERUMO, Introducer II ), GlideSheath Slender® has more smaller outer-side diameter. The investigators suspected that use of the GlideSheath Slender® can reduce the incidence of distal radial artery occlusion in cardiovascular intervention via dTRA approach. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
GlideSheath Slender® and conventional arterial sheath and Conventional arterial sheath
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteChina
Study dates
15 Sep 2022to 28 Feb 2024
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Palpable distal radial and conventional radial artery

Who cannot join

  • Age ≥ 90years
  • Height≥ 185cm
  • ST-segment elevation myocardial infarction or Cardiogenic shock
  • Contraindications to puncture at the puncture site
  • Diameter of DRA less than 1.5mm or RAO

Trial locations and contacts

1 site in 1 country.

Gaojun Cai, Dr. contact

086-0519-85579193

cgj982@126.com

China1 site, 1 recruiting

  • Changzhou Wujin People's Hospital

    Changzhou, Jiangsu, 213017

    Gaojun Cai, MD, +86-0519-85579193, cgj982@126.com

    Recruiting

Other trials in China

About this study

Official title: GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Incidence of Distal Radial Artery Occlusion in Cardiovascular Intervention Via Distal Radial Artery (SMART)

Compared with conventional artery sheath (TERUMO, Introducer II ), GlideSheath Slender® has more smaller outer-side diameter. The investigators suspected that use of the GlideSheath Slender® can reduce the incidence of distal radial artery occlusion in cardiovascular intervention via dTRA approach.

Read the detailed description

Distal transradial artery (dTRA) approach has emerged as a new approach in cardiovascular intervention in recent years. Compared to the conventional radial artery (CRA) approach, the dTRA approach dramatically reduced the risk of radial artery occlusion (RAO). In recent years, the incidence of distal radial artery occlusion (dRAO) after dTRA intervention has been reported in the literature, ranged from 0.12% to 5.2%. Outside diameter of artery sheath may affect the incidence of dRAO. Retrospective study reported that an artery/ sheath ratio > 1.0 was least damaging to the vessel during coronary intervention via dTRA. Compared with conventional artery sheath (TERUMO, Introducer II ), 6 French GlideSheath Slender® has more smaller outer-side diameter (2.46mm vs. 2.62mm). The investigators suspected that use of the GlideSheath Slender can reduce the incidence of dRAO in cardiovascular intervention via dTRA approach.

Being tested
GlideSheath Slender® and conventional arterial sheath, Conventional arterial sheath
Keywords
distal radial artery, distal radial artery occlusion, cardiovascular intervention
Medical subject headings
Coronary Artery Disease, Cardiovascular Diseases

What participants receive

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

  • GlideSheath Slender® and conventional arterial sheathDevice

    Using the GlideSheath Slender® with the outside diameter 2.46mm

  • Conventional arterial sheathDevice

    Placement of 6 French conventional Sheath (TERUMO, Introducer II )

Study groups in NCT05501925
Study groupRoleWhat they receive
GlideSheath Slender®ExperimentalPlacement of 6 French GlideSheath Slender® for cardiovascular intervention via distal radial artery
Receives: Device: GlideSheath Slender® and conventional arterial sheath
Conventional SheathActive comparatorPlacement of 6 French conventional Sheath (TERUMO, Introducer II ) for cardiovascular intervention via distal radial artery
Receives: Device: Conventional arterial sheath

What is being measured

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

  1. Rate of distal radial artery occlusion

    The rate of distal radial artery occlusion is evaluated by ultrasound

    Measured: 24 hours after the coronary angiography or intervention

Secondary outcomes (5)

  1. Rate of radial artery occlusion

    The rate of radial artery occlusion is evaluated by ultrasound

    Measured: 24 hours after the coronary angiography or intervention

  2. Pain during the placement of the sheath

    Visual analog scale is used to evaluate the pain during the placement of the sheath, which ranges from 0-10, and 0 meas no pain

    Measured: 24 hours after the coronary angiography or intervention

  3. Radial artery dissection

    The incidence of dissection of the radial artery is evaluated by ultrasound

    Measured: 24 hours after the coronary angiography or intervention

  4. Time of hemostasis

    The time from the compress to hemostasis

    Measured: 24 hours after the coronary angiography or intervention

  5. Haematoma

    The incidence of haematoma is evaluated by Early Discharge After Transradial Stenting of Coronary Arteries Study criteria

    Measured: 24 hours after the coronary angiography or intervention

Timeline

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

  1. First posted16 Aug 2022
  2. Study start15 Sep 2022
  3. Primary completion28 Feb 2024 (estimated)
  4. Study completion28 Feb 2024 (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
Model description
GlideSheath Slender® group Conventional Sheath group (TERUMO, Introducer II )
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05501925
Sponsor's protocol ID
WJH20220731
Acronym
SMART
Status last verified
Dec 2023
First submitted
6 Aug 2022
Last updated
19 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079.

    PubMed 28506941

  • Achim A, Kakonyi K, Jambrik Z, Nagy F, Toth J, Sasi V, Hausinger P, Nemes A, Varga A, Bertrand OF, Ruzsa Z. Distal Radial Artery Access for Coronary and Peripheral Procedures: A Multicenter Experience. J Clin Med. 2021 Dec 20;10(24):5974. doi: 10.3390/jcm10245974.

    PubMed 34945269

  • Tsigkas G, Papageorgiou A, Moulias A, Kalogeropoulos AP, Papageorgopoulou C, Apostolos A, Papanikolaou A, Vasilagkos G, Davlouros P. Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center, Randomized Study. JACC Cardiovasc Interv. 2022 Jan 10;15(1):22-32. doi: 10.1016/j.jcin.2021.09.037. Epub 2021 Dec 15.

    PubMed 34922888

  • Liang C, Han Q, Jia Y, Fan C, Qin G. Distal Transradial Access in Anatomical Snuffbox for Coronary Angiography and Intervention: An Updated Meta-Analysis. J Interv Cardiol. 2021 Jul 22;2021:7099044. doi: 10.1155/2021/7099044. eCollection 2021.

    PubMed 34381321

  • Cai G, Huang H, Li F, Shi G, Yu X, Yu L. Distal transradial access: a review of the feasibility and safety in cardiovascular angiography and intervention. BMC Cardiovasc Disord. 2020 Aug 5;20(1):356. doi: 10.1186/s12872-020-01625-8.

    PubMed 32758150

  • Naito T, Sawaoka T, Sasaki K, Iida K, Sakuraba S, Yokohama K, Sato H, Soma M, Okamura E, Harada T, Yoshimachi F. Evaluation of the diameter of the distal radial artery at the anatomical snuff box using ultrasound in Japanese patients. Cardiovasc Interv Ther. 2019 Oct;34(4):312-316. doi: 10.1007/s12928-018-00567-5. Epub 2019 Jan 7.

    PubMed 30617776

  • Li F, Zhou T, Fan X, Chen T, Shi G, Li L, Cai G. Safety and Efficacy of Distal Transradial Access in Patients With Small Diameter Distal Radial Artery: A Post Hoc Analysis of 2 Randomized Trials. Can J Cardiol. 2026 Jun;42(6):1221-1229. doi: 10.1016/j.cjca.2025.12.048. Epub 2025 Dec 30.

    PubMed 41478549

  • Lu W, Chen T, Wang H, Yang A, Li L, Shi G, Xue S, Li F, Xiao J, Gu J, Zhang L, Liang X, Li W, Cai G. Comparison of the Effect of a 6-French Glidesheath Slender and a Conventional Sheath on Distal Radial Artery Occlusion: A Randomized Controlled Trial. Can J Cardiol. 2024 Nov;40(11):2292-2300. doi: 10.1016/j.cjca.2024.07.011. Epub 2024 Jul 19.

    PubMed 39032557

Questions about this trial

What is this clinical trial studying?

A study testing GlideSheath Slender® and conventional arterial sheath and Conventional arterial sheath in people with Coronary Artery Disease and Cardiovascular Diseases, run by Wujin People's Hospital 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 2 inclusion and 5 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 19 Dec 2023. 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 Gaojun Cai, Dr. (086-0519-85579193, cgj982@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of distal radial artery occlusion (time frame: 24 hours after the coronary angiography or intervention). 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 NCT05501925, which also lists 8 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 19 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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