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NCT06835829 | NOT YET RECRUITING | Coronary Catheterization

Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access
Sponsor:

Association for the study of cardivascular diseases Cardiva Onlus

Information provided by (Responsible Party):

Gregory A. Sgueglia

Brief Summary:

Meta-analysis results show that distal radial access (DRA) is associated with a significant reduction in the risk of radial artery occlusion compared to conventional transradial access (TRA). This is of paramount importance in an evolving interventional context where an increasing number of radial access procedures are being performed to address a growing number of independent health conditions. DRA is also associated with a lower rate of vascular access-related adverse events, establishing it as the safest vascular access ever. However, available data show that the success rate of DRA is lower than that of conventional TRA. Also, while the duration of hemostasis has been shown to be shorter, it has most likely not yet reached its full potential for shortening. Thus, the two extreme phases of DRA require important further evaluation. The CompAring uLtrasound-guided Puncture and advanced HemostAsis to cOnventional approaches in distal radial access: a dual randoMizEd praGmatic triAl (ALPHA\&OMEGA) trial will address this lack of knowledge by exploring whether a significantly shorter hemostasis duration can be achieved with DRA when using hemostasis enhancement and exploring whether ultrasound-guided puncture can increase the success rate of DRA.

Condition or disease

Coronary Catheterization

Intervention/treatment

Transradial potassium ferrate hemostatic patch

Distal radial potassium ferrate hemostatic patch

Ultrasound-guidance

Conventional guidance

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 480 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access: A Dual Randomized Pragmatic Trial
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age ≥18 years.
  • * Patients presenting with CCS or ACS, including unstable angina or NSTEMI.
  • * Patients planned for coronary angiography or PCI.
  • * Patients able to provide written informed consent.
  • * Patient is willing to comply with all study protocol required evaluations.
  • * Palpable radial pulse both at conventional and distal puncture site.
  • * Reverse modified Barbeau test confirming radial artery patency in patients with a history of previous radial artery catheterization.
Exclusion Criteria
  • * Acute ST-segment elevation myocardial infarction.
  • * Cardiogenic shock.
  • * Chronic hemodialysis.
  • * Contraindications to radial access, such as occlusive upper arm peripheral artery disease, or known anatomic variants prohibiting TRA on both sides.
  • * Medical conditions that may cause non-compliance with the study protocol and/or may confound the data interpretation.
  • * Patients unable to provide written informed consent.
Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access

Location Details

NCT06835829

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