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

November 12, 2023 updated by: Guering Eid Lidt, Instituto Nacional de Cardiologia Ignacio Chavez

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2922

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico
        • Recruiting
        • Instituto Nacional de Cardiología Ignacio Chavez
        • Contact:
        • Sub-Investigator:
          • Norman Said Vega Servin, PhD
        • Sub-Investigator:
          • Arnoldo Enmanuel Loaisiga Saenz, PhD
        • Sub-Investigator:
          • Eduardo Agustin Arias Sánchez, PhD
        • Sub-Investigator:
          • Jorge Gaspar Hernandez, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • STEMI patients underwent PCI.
  • Patent radial access (distal and conventional)
  • Patients who agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

  • Cardiogenic shock.
  • Previous coronary artery bypass grafting (CABG).
  • Absence of palpable radial pulse.
  • Arteriovenous fistula for hemodialysis.
  • Previous radial artery occlusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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.
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of adverse events of all-cause mortality, myocardial infarction, cerebral vascular event, BARC 3-5 (Bleeding Academic Research Consortium), myocardial infarction and cerebrovascular event, bleeding measure will be with BARC classification.
Time Frame: 24 hours and 30 days after PCI.
At 24 hours and 30 days after the procedure, patients will be evaluated by radial doppler ultrasonography, lab test, and interrogation of clinical adverse events during hospital stay or 30 days after PCI.
24 hours and 30 days after PCI.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of myocardial infarction after the procedure
Time Frame: 24 hours to 30 days after PCI
A new STEMI event is an event that meets the fourth definition of a myocardial infarction according to the current guidelines.
24 hours to 30 days after PCI
Incidence of cerebral vascular event (hemorrhagic or ischemic stroke) after the procedure
Time Frame: 24 hours to 30 days after PCI.
Diagnosed by a doctor based on clinical symptoms and imaging tests (CT scan).
24 hours to 30 days after PCI.
Urgent TVR (Revascularization of the treated vessel)
Time Frame: If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI.
Diagnosed by coronary angiography or intracoronary imaging (IVUS/OCT) showing a complication related to the culprit vessel of the initial event.
If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI.
Definite stent thrombosis
Time Frame: If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI.
Diagnosed by coronary angiography or intracoronary imaging (IVUS/OCT) showing a complication related to the culprit vessel of the initial event.
If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI.
Bleeding assessed by BARC 3-5 to 30 days of evolution in patients with STEMI who received interventional treatment via RD access versus RC access.
Time Frame: 24 hours to 30 days after PCI.
Evaluated by BARC scale will be used to classify the severity of bleeding into types 0-5 (3-5 are the most important criteria for the clinical trial will define the worse outcome ) Type 0 = no evidence of bleeding Type 1 = minimal bleeding Type 2 = clinically evident bleeding other than 3, 4 or 5 Type 3 = with haematocrit fall ≥ 3g% and/or hemodynamic compromise and/or requiring transfusion and/or intracranial or intraocular bleeding Type 4 = associated with Myocardial Revascularization Surgery Type 5 = fatal bleeding.
24 hours to 30 days after PCI.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Investigators

  • Study Chair: Guering Eid Lidt, PhD, Guering Eid-Lidt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-1367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD will be shared

IPD Sharing Time Frame

january 2025 to january 2026

IPD Sharing Access Criteria

IPD will be shared for related studies, without distinctions in the nature of each study, information may be freely requested directly by e-mail and each request will be evaluated by the principal investigator of the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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