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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Jaffe, Ronen, M.D..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Jaffe, Ronen, M.D.
ClinicalTrials.gov Identifier:
NCT01753817
First received: December 18, 2012
Last updated: December 26, 2012
Last verified: December 2012
  Purpose
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
Coronary Catheterization
Transradial Patency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Radial Artery Patency Following Catheterization With a 7F Sheath

Further study details as provided by Jaffe, Ronen, M.D.:

Primary Outcome Measures:
  • Normal reverse Allen test [ Time Frame: Within 2 years of the initial procedure ] [ Designated as safety issue: No ]
    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:
  • Antegrade flow in the radial artery by ultrasound [ Time Frame: Within 2 years of the initial procedure ] [ Designated as safety issue: No ]
    Radial artery flow will be studied with Doppler ultrasound


Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study cohort
Cohort of patients who have previously undergone transradial catheterization with the use of a 7F vascular sheath

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: December 18, 2012
Last Updated: December 26, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on July 21, 2016