NCT06013813

Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI

Adverse Clinical Outcomes Associated With Conventional Versus Distal Radial Access in Patients With Acute Coronary Syndrome With ST-segment Elevation Treated by Percutaneous Coronary Intervention

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,922 (estimated)
• Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to compare conventional radial access versus distal radial access in patients with STEMI undergoing PCI. The main question it aims to answer is: • Mayor adverse cardiac events (MACE) at 30 days in STEMI patients treated by PCI are not inferior when comparing the distal radial approach versus the conventional radial approach ? Participants will: * sign the informed consent to enroll in the clinical trial. * will agree to be treated by PCI * will be randomized 1:1 to perform PCI by conventional radial or distal radial approach. If there is a comparison group: Researchers will compare conventional radial access vs distal radial access to see if the distal approach is not inferior compared to the conventional radial access in order to offer less or equal MACE and a similar rate of a successful procedure.

Conditions

• STEMI - ST Elevation Myocardial Infarction
• Myocardial Infarction
• Acute Coronary Syndrome

Interventions

Type	Name	Description
PROCEDURE	Radial Artery approach on percutaneous coronary intervention (PCI)	* Randomized patients with a right patent radial artery. * The outcomes of the distal radial approach will be compared with those of the conventional radial approach. * Technique and devices (introducer and compression devices) are the same in both approaches.

Timeline

• Start date: 2023-09-07
• Primary completion: 2024-12-01
• Completion: 2025-02-01
• First posted: 2023-08-28
• Last updated: 2023-11-15

Locations

1 site across 1 country: Mexico