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Distal Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients (RESERVE)

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ClinicalTrials.gov Identifier: NCT04861389
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Shenzhen People's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute ST-segment Elevation Myocardial Infarction Radial Artery Occlusion Distal Radial Artery Approach Procedure: Arterial access Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Distal transradial access (dTRA)
Distal transradial access for primary percutaneous coronary intervention in STEMI patients
 Procedure: Arterial access
Arterial access for primary percutaneous coronary intervention in STEMI patients
Active Comparator: Transradial access (TRA)
Transradial access for primary percutaneous coronary intervention in STEMI patients
 Procedure: Arterial access
Arterial access for primary percutaneous coronary intervention in STEMI patients


Outcome Measures
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Primary Outcome Measures :
  1. The RAO incidence during hospitalization [ Time Frame: 7 days ]
    The incidence of radial artery occlusion during hospitalization


Secondary Outcome Measures :
  1. Puncture time [ Time Frame: During the intervention ]
    Puncture time

  2. Compression time [ Time Frame: 4-24 hours ]
    Compression time

  3. Puncture success rate [ Time Frame: During the intervention ]
    Puncture success rate

  4. Incidence of hematoma, finger numbness or pain during hospitalization [ Time Frame: 7days ]
    Incidence of hematoma, finger numbness or pain during hospitalization

  5. Incidence of RAO at 1 and 6 months after surgery [ Time Frame: 1 and 6 months ]
    Incidence of RAO at 1 and 6 months after surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04861389


Contacts
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Contact: Xin Sun, MD +86-755-22942705 sunxinflying@163.com

Locations
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China, Guangdong
Shenzhen People's Hospital Recruiting
Shenzhen, Guangdong, China, 518020
Contact: Xin Sun, MD    +86-755-22943205    sunxinflying@163.com   
Sponsors and Collaborators
Shenzhen People's Hospital
Investigators
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Study Chair: Shaohong Dong, MD Shenzhen People's Hospital
More Information
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Responsible Party: Shenzhen People's Hospital
ClinicalTrials.gov Identifier: NCT04861389    
Other Study ID Numbers: RESERVE.01
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases