Distal Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients (RESERVE)
Primary Purpose
Acute ST-segment Elevation Myocardial Infarction, Radial Artery Occlusion, Distal Radial Artery Approach
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Arterial access
Sponsored by
About this trial
This is an interventional prevention trial for Acute ST-segment Elevation Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of STEMI
- To undergo emergency PCI treatment
- Palpable pulsation of the radial artery and distal radial artery
Exclusion Criteria:
- Arteriovenous fistula of radial artery and cephalic vein has been performed with regular hemodialysis
- Suspicious left main block of electrocardiogram
- Had used the radial artery percutaneous interventional treatment before
- Cardiogenic shock
Sites / Locations
- Shenzhen People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Distal transradial access (dTRA)
Transradial access (TRA)
Arm Description
Distal transradial access for primary percutaneous coronary intervention in STEMI patients
Transradial access for primary percutaneous coronary intervention in STEMI patients
Outcomes
Primary Outcome Measures
The RAO incidence during hospitalization
The incidence of radial artery occlusion during hospitalization
Secondary Outcome Measures
Puncture time
Puncture time
Compression time
Compression time
Puncture success rate
Puncture success rate
Incidence of hematoma, finger numbness or pain during hospitalization
Incidence of hematoma, finger numbness or pain during hospitalization
Incidence of RAO at 1 and 6 months after surgery
Incidence of RAO at 1 and 6 months after surgery
Full Information
NCT ID
NCT04861389
First Posted
November 29, 2020
Last Updated
April 26, 2021
Sponsor
Shenzhen People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04861389
Brief Title
Distal Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients
Acronym
RESERVE
Official Title
The Comparison of Distal Transradial Access and Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients(RESERVE Trial) A Single-center, Open, Prospective, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen 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
No
5. Study Description
Brief Summary
The transradial access (TRA) is currently the preferred approach for percutaneous coronary intervention (PCI). However, in patients with ACUTE ST-segment elevation myocardial infarction (STEMI) after emergency PCI, the high incidence of THE radial artery RAO limits the future choice of the radial artery for percutaneous intervention. The literature reported that distal transradial access (dTRA) significantly reduced RAO after elective PCI, but the application of dTRA in emergency PCI in STEMI has not been reported. We have completed 126 cases of dTRA undergoing emergency PCI after STEMI, which has been preliminarily confirmed to be safe and effective. A single-center, open, prospective, randomized controlled study is planned to compare the use of dTRA and TRA in emergency PCI in STEMI patients. The primary endpoint was the INCIDENCE of RAO within 24 hours after surgery. This clinical study verified that dTRA compared with TRA could reduce the RAO incidence of STEMI patients after emergency PCI. The project will explore a new artery approach to reduce RAO, and provide a basis for the selection of artery approach in STEMI emergency PCI patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute ST-segment Elevation Myocardial Infarction, Radial Artery Occlusion, Distal Radial Artery Approach
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
414 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Distal transradial access (dTRA)
Arm Type
Experimental
Arm Description
Distal transradial access for primary percutaneous coronary intervention in STEMI patients
Arm Title
Transradial access (TRA)
Arm Type
Active Comparator
Arm Description
Transradial access for primary percutaneous coronary intervention in STEMI patients
Intervention Type
Procedure
Intervention Name(s)
Arterial access
Intervention Description
Arterial access for primary percutaneous coronary intervention in STEMI patients
Primary Outcome Measure Information:
Title
The RAO incidence during hospitalization
Description
The incidence of radial artery occlusion during hospitalization
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Puncture time
Description
Puncture time
Time Frame
During the intervention
Title
Compression time
Description
Compression time
Time Frame
4-24 hours
Title
Puncture success rate
Description
Puncture success rate
Time Frame
During the intervention
Title
Incidence of hematoma, finger numbness or pain during hospitalization
Description
Incidence of hematoma, finger numbness or pain during hospitalization
Time Frame
7days
Title
Incidence of RAO at 1 and 6 months after surgery
Description
Incidence of RAO at 1 and 6 months after surgery
Time Frame
1 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of STEMI
To undergo emergency PCI treatment
Palpable pulsation of the radial artery and distal radial artery
Exclusion Criteria:
Arteriovenous fistula of radial artery and cephalic vein has been performed with regular hemodialysis
Suspicious left main block of electrocardiogram
Had used the radial artery percutaneous interventional treatment before
Cardiogenic shock
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Sun, MD
Phone
+86-755-22942705
Email
sunxinflying@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaohong Dong, MD
Organizational Affiliation
Shenzhen People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Sun, MD
Phone
+86-755-22943205
Email
sunxinflying@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Distal Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients
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