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

Primary Purpose

Coronary Artery Disease, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GlideSheath Slender® and conventional arterial sheath
Conventional arterial sheath
Sponsored by
Wujin People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring distal radial artery, distal radial artery occlusion, cardiovascular intervention

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Age ≥ 90years
  • Height≥ 185cm
  • Cardiogenic shock
  • Contraindications to puncture at the puncture site

Sites / Locations

  • Changzhou Wujin People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GlideSheath Slender®

Conventional Sheath

Arm Description

Placement of 6 French GlideSheath Slender® for cardiovascular intervention via distal radial artery

Placement of 6 French conventional Sheath (TERUMO, Introducer II ) for cardiovascular intervention via distal radial artery

Outcomes

Primary Outcome Measures

Rate of distal radial artery occlusion
The rate of distal radial artery occlusion is evaluated by ultrasound

Secondary Outcome Measures

Rate of radial artery occlusion
The rate of radial artery occlusion is evaluated by ultrasound
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
Radial artery dissection
The incidence of dissection of the radial artery is evaluated by ultrasound
Time of hemostasis
The time from the compress to hemostasis
Haematoma
The incidence of haematoma is evaluated by Early Discharge After Transradial Stenting of Coronary Arteries Study criteria

Full Information

First Posted
August 6, 2022
Last Updated
October 24, 2022
Sponsor
Wujin People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05501925
Brief Title
GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Distal Radial Artery Occlusion (SMART)
Acronym
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
September 14, 2023 (Anticipated)
Study Completion Date
December 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wujin People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Cardiovascular Diseases
Keywords
distal radial artery, distal radial artery occlusion, cardiovascular intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
GlideSheath Slender® group Conventional Sheath group (TERUMO, Introducer II )
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GlideSheath Slender®
Arm Type
Experimental
Arm Description
Placement of 6 French GlideSheath Slender® for cardiovascular intervention via distal radial artery
Arm Title
Conventional Sheath
Arm Type
Active Comparator
Arm Description
Placement of 6 French conventional Sheath (TERUMO, Introducer II ) for cardiovascular intervention via distal radial artery
Intervention Type
Device
Intervention Name(s)
GlideSheath Slender® and conventional arterial sheath
Intervention Description
Using the GlideSheath Slender® with the outside diameter 2.46mm
Intervention Type
Device
Intervention Name(s)
Conventional arterial sheath
Intervention Description
Placement of 6 French conventional Sheath (TERUMO, Introducer II )
Primary Outcome Measure Information:
Title
Rate of distal radial artery occlusion
Description
The rate of distal radial artery occlusion is evaluated by ultrasound
Time Frame
24 hours after the coronary angiography or intervention
Secondary Outcome Measure Information:
Title
Rate of radial artery occlusion
Description
The rate of radial artery occlusion is evaluated by ultrasound
Time Frame
24 hours after the coronary angiography or intervention
Title
Pain during the placement of the sheath
Description
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
Time Frame
24 hours after the coronary angiography or intervention
Title
Radial artery dissection
Description
The incidence of dissection of the radial artery is evaluated by ultrasound
Time Frame
24 hours after the coronary angiography or intervention
Title
Time of hemostasis
Description
The time from the compress to hemostasis
Time Frame
24 hours after the coronary angiography or intervention
Title
Haematoma
Description
The incidence of haematoma is evaluated by Early Discharge After Transradial Stenting of Coronary Arteries Study criteria
Time Frame
24 hours after the coronary angiography or intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Palpable distal radial and conventional radial artery Exclusion Criteria: Age ≥ 90years Height≥ 185cm Cardiogenic shock Contraindications to puncture at the puncture site
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaojun Cai, Dr.
Phone
086-0519-85579193
Email
cgj982@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaojun Cai
Organizational Affiliation
Wujin hospital affiliated with Jiangsu University
Official's Role
Study Chair
Facility Information:
Facility Name
Changzhou Wujin People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213017
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaojun Cai, MD
Phone
+86-0519-85579193
Email
cgj982@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28506941
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.
Results Reference
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PubMed Identifier
34945269
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.
Results Reference
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PubMed Identifier
34922888
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.
Results Reference
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PubMed Identifier
34381321
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.
Results Reference
background
PubMed Identifier
32758150
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.
Results Reference
background
PubMed Identifier
30617776
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.
Results Reference
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GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Distal Radial Artery Occlusion (SMART)

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