Distal Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients

NCT04861389 | Unknown

• 1 other identifier: RESERVE.01
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute ST-segment Elevation Myocardial Infarction; Radial Artery Occlusion; Distal Radial Artery Approach

Outcome Measures

Primary Outcomes (1)

• The RAO incidence during hospitalization

  The incidence of radial artery occlusion during hospitalization

  7 days

Secondary Outcomes (5)

• Puncture time

  During the intervention

• Compression time

  4-24 hours

• Puncture success rate

  During the intervention

• Incidence of hematoma, finger numbness or pain during hospitalization

  7days

• Incidence of RAO at 1 and 6 months after surgery

  1 and 6 months

Study Arms (2)

Distal transradial access (dTRA)

EXPERIMENTAL

Distal transradial access for primary percutaneous coronary intervention in STEMI patients

Procedure: Arterial access

Transradial access (TRA)

ACTIVE COMPARATOR

Transradial access for primary percutaneous coronary intervention in STEMI patients

Procedure: Arterial access

Interventions

Arterial access PROCEDURE

Arterial access for primary percutaneous coronary intervention in STEMI patients

Distal transradial access (dTRA); Transradial access (TRA)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of STEMI
• To undergo emergency PCI treatment
• Palpable pulsation of the radial artery and distal radial artery

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Arterial Occlusive Diseases

Interventions

Vascular Access Devices

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Shaohong Dong, MD

  Shenzhen People's Hospital

  STUDY CHAIR

Central Study Contacts

Xin Sun, MD

CONTACT

+86-755-22942705; sunxinflying@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: April 27, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)