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Transradial Versus Transulnar Artery Approach for Coronary Interventions

NCT01364532 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2011-06-02

No results posted yet for this study

Summary

The transradial route is increasingly used as an access site in percutaneous coronary interventions, as it is considered equivalent to transfemoral approach in terms of efficacy but with a decreased vascular complication risk. Information concerning the efficacy and safety of transulnar approach is sparse. This is a prospective, randomized, investigator-initiated study to compare transradial versus transulnar approach as a default strategy for coronary angiography, ad-hoc or elective percutaneous coronary intervention (PCI). Consecutive eligible patients with an indication for coronary angiography, will be randomized after written informed consent in a 1:1 ratio to either transradial or transulnar access. Assessment of angiographic and procedural characteristics(including amount of contrast medium, arterial access, fluoroscopy and procedural time), as well as any vascular or other peri-procedural complications of the cases enrolled, will be performed. After hospital discharge, all patients will return at Day 60 ±5 days for Doppler ultrasound assessment of the forearm vessels and documentation of major adverse cardiovascular events (defined as death, myocardial infarction, target vessel revascularization and stroke. Coronary angiography patients will be additionally randomized in a 1:1 ratio to either 2500 or 5000 IU of unfractioned heparin.

Conditions

  • Arterial Access in Percutaneous Coronary Angiography or Intervention

Interventions

PROCEDURE

Transulnar arterial access

Transulnar arterial access in coronary angiography, ad-hoc or elective PCI

PROCEDURE

Transradial arterial access

Transradial arterial access for coronary angiography,ad-hoc or elective PCI

Sponsors & Collaborators

  • University of Patras

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01364532 on ClinicalTrials.gov