We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of Radial Artery Patency Following Catheterization With a 7F Sheath

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01753817
Recruitment Status : Unknown
Verified December 2012 by Jaffe, Ronen, M.D..
Recruitment status was:  Not yet recruiting
First Posted : December 20, 2012
Last Update Posted : December 27, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Radial artery occlusion may occur after performance of coronary catheterization via the radial artery (transradial approach). In some cases it may be desirable to insert large (7F) catheters via the radial artery, however the impact of increased catheter size on subsequent radial artery patency is unclear. We hypothesize that radial artery occlusion following 7F catheterization is rare and occurs in < 5% of the cases.

Condition or disease
Coronary Catheterization Transradial Patency

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Radial Artery Patency Following Catheterization With a 7F Sheath
Study Start Date : January 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : January 2015
Groups and Cohorts

Group/Cohort
Study cohort
Cohort of patients who have previously undergone transradial catheterization with the use of a 7F vascular sheath


Outcome Measures

Primary Outcome Measures :
  1. Normal reverse Allen test [ Time Frame: Within 2 years of the initial procedure ]
    Radial artery patency will be studied with the reverse Allen test. This test is performed by simultaneously occluding both the radial and ulnar arteries until no pulse signal is detected with a pulse oximeter placed on the index finger. The pressure on the radial artery is then released and reappearance of the pulse signal on the oximeter is documented-signifying antegrade flow in the radial artery. This test is not associated with any reported complications or morbidity.


Secondary Outcome Measures :
  1. Antegrade flow in the radial artery by ultrasound [ Time Frame: Within 2 years of the initial procedure ]
    Radial artery flow will be studied with Doppler ultrasound


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Two-hundred subjects who have previously undergone transradial cathetrization between the years 1999 and 2012 with a 7F sheath will be identified in the Lady Davis Carmel Medical Center Catheterization laboratory computerized database.
Criteria

Inclusion Criteria:

  • Previous transradial catheterization with a 7F vascular sheath

Exclusion Criteria:

  • Inability to give informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753817


Contacts
Contact: Ronen Jaffe, MD 972-50-6265830 jaffe@clalit.org.il

Locations
Israel
Carmel Medical Center Enrolling by invitation
Haifa, Israel, 34362
Sponsors and Collaborators
Jaffe, Ronen, M.D.
Investigators
Principal Investigator: Ronen Jaffe, MD Carmel Medical Center
More Information

Publications:
Responsible Party: Jaffe, Ronen, M.D.
ClinicalTrials.gov Identifier: NCT01753817     History of Changes
Other Study ID Numbers: CMC-12-0016 CTIL
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: December 2012

Keywords provided by Jaffe, Ronen, M.D.:
Coronary catheterization
Transradial patency