Status:

UNKNOWN

Efficacy and Safety of Hemostatic Methods in Distal Radial Artery Approach for Cardiac Catheterization

Lead Sponsor:

Instituto Nacional de Cardiologia Ignacio Chavez

Conditions:

Coronary Intervention

Transradial Approach

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Comparison of PreludeSYNC distal and Modified Terumo Radial Band in patients with distal radial approach.

Detailed Description

INTRODUCTION AND BACKGROUND Distal radial access at the level of the anatomical snuffbox and dorsal region of the hand has currently positioned itself as a viable and safe approach for procedures in ...

Eligibility Criteria

Inclusion

  • Coronary artery disease including chronic coronary syndrome or acute coronary syndrome.
  • Cardiovascular disease that requires coronary angiography in its approach.

Exclusion

  • Cardiogenic shock.
  • Lesions in venous or arterial hemoducts.
  • Impossibility to provide informed consent.
  • Chronic kidney disease on hemodialysis through arteriovenous fistula at the same site where the approach is planned.
  • Severe chronic renal failure (GFR less than 30 ml/min/m2)
  • Patients diagnosed with cancer.
  • Patient with rheumatological and hematological pro-thrombotic disorders.
  • Non-hydrophilic radial introducer.
  • Failed cannulation of the radial artery with an introducer.
  • Successful trans-radial access that is crossed over to the femoral approach.
  • Patients with an interventional procedure using a radial approach in the previous 30 days.

Key Trial Info

Start Date :

February 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2023

Estimated Enrollment :

482 Patients enrolled

Trial Details

Trial ID

NCT05966376

Start Date

February 1 2022

End Date

December 1 2023

Last Update

September 21 2023

Active Locations (1)

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1

Instituto Nacional de Cardiologia Ignacio Chávez

Mexico City, Mexico, 14080