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: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• STEMI patients underwent PCI.

• Patent radial access (distal and conventional)

• Patients who agree to participate in the study and sign the informed consent form.

Locations
Other Locations
Mexico
Instituto Nacional de Cardiología Ignacio Chávez
RECRUITING
Mexico City
Contact Information
Primary
Juan Carlos Plata Corona, PhD
juancarlosplatacorona3@gmail.com
+522212187940
Backup
Guering Eid Lidt, PhD
gueringeid@gmail.com
+525585803787
Time Frame
Start Date: 2023-09-07
Estimated Completion Date: 2025-02-01
Participants
Target number of participants: 2922
Treatments
Experimental: Distal radial approach
* Clean and dry the puncture site.~* Simple lidocaine 2% is infiltrated.~* The artery is punctured in the radial distal zone, and a 6 Fr hydrophilic radial introducer is placed with the Seldinger technique.~* Verapamil 2.5 mg and Heparin 5000 IU are administered.~* PCI is performed.~* Finally, the introducer is withdrawn with the patent hemostasis technique, and a radial compression device is placed (prelude mostly or terumo).
Active_comparator: Conventional radial approach (proximal radial approach).
* Clean and dry the puncture site.~* Simple lidocaine 2% is infiltrated.~* The artery is punctured in the radial proximal zone, and a 6 Fr hydrophilic radial introducer is placed with the Seldinger technique.~* Verapamil 2.5 mg and Heparin 5000 IU are administered.~* PCI is performed.~* Finally, the introducer is withdrawn with the patent hemostasis technique, and a radial compression device is placed (terumo).
Sponsors
Leads: Instituto Nacional de Cardiologia Ignacio Chavez

This content was sourced from clinicaltrials.gov