Clinical trial NCT05501925: GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Distal Radial Artery Occlusion (SMART)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Cardiovascular Diseases
Keywords: distal radial artery
distal radial artery occlusion
cardiovascular intervention
Lead sponsor: Wujin People's Hospital
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: GlideSheath Slender® group Conventional Sheath group (TERUMO, Introducer II )
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of distal radial artery occlusion
timeFrame: 24 hours after the coronary angiography or intervention
Secondary outcomes:
measure: Rate of radial artery occlusion
timeFrame: 24 hours after the coronary angiography or intervention
measure: Pain during the placement of the sheath
timeFrame: 24 hours after the coronary angiography or intervention
measure: Radial artery dissection
timeFrame: 24 hours after the coronary angiography or intervention
measure: Time of hemostasis
timeFrame: 24 hours after the coronary angiography or intervention
measure: Haematoma
timeFrame: 24 hours after the coronary angiography or intervention
Other outcomes:
Locations:
city: Changzhou
country: China
facility: Changzhou Wujin People's Hospital
state: Jiangsu
Study officials:
affiliation: Wujin hospital affiliated with Jiangsu University
name: Gaojun Cai
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.