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Completed

NCT Number: NCT02269722

Postcath Radial Arterial Clamp Time In the CAth Lab

The investigators will assess the effect of different times of radial clamp post procedure on radial artery occlusion and bleeding.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

London Health Science Center

London, Ontario, N6A5A5, Canada

About this study

The purpose of this study is to determine the safety of shorter radial artery clamp time post cardiac catheterization with respect to achieving hemostasis and the incidence of radial artery occlusion. The investigators hypothesize that shorter radial artery clamp times following cardiac catheterization will achieve similar hemostasis to longer clamp times with a decrease in the incidence of radial artery occlusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients who require cardiac catheterization via the radial approach for the investigation and treatment of coronary artery disease.
  • Patients must have evidence of pre-procedural radial artery patency using Barbeau test.
  • Patients must be able to give informed consent

Exclusion criteria

  • Evidence of pre-procedural radial artery thrombosis
  • Inability to give informed consent
  • Patient desire not to participate in the study
  • Emergent procedures when the delay associated for obtaining informed consent may affect patient outcome

Treatment and study plan

Vascular compression device- RADAR TM-Short clamp time

Device

A clamp is placed on the radial artery following cardiac catheterization for 20 minutes

Vascular compression device RADAR TM-Long clamp time

Device

A clamp is placed on the radial artery following cardiac catheterization for 20 minutes

Primary outcomes

  1. Incidence of radial artery occlusion

    Time frame: 24 hours

    Flow assessed by pulse oximeter

Secondary outcomes

  1. Bleeding

    Time frame: 24 hours

    Need to retighten clamp, ooze, hematoma

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

A Comparison of Radial Artery Clamp Times in Patients Undergoing Cardiac Catheterization Via a Percutaneous Transradial Approach

Acronym: PRACTICAL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2014
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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