Transradial Versus Transulnar Artery Approach for Coronary Interventions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

572 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Arterial Access in Percutaneous Coronary Angiography or Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Transulnar arterial access

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

Group Type EXPERIMENTAL

Transulnar arterial access

Intervention Type PROCEDURE

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

Transradial arterial access

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

Group Type ACTIVE_COMPARATOR

Transradial arterial access

Intervention Type PROCEDURE

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

Interventions

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Transulnar arterial access

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

Intervention Type PROCEDURE

Transradial arterial access

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age\>18 years
* Plan for Coro- and ad hoc PCI, if necessary
* Written informed consent

Exclusion Criteria

* Cardiogenic shock, haemodynamic instability, Killip class III
* Chronic hemodialysis
* Coronary artery bypass grafting (CABG) with either bilateral internal mammary artery (IMA) or bilateral radial artery use

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No