NCT01753817

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

December 27, 2012

Status Verified

December 1, 2012

Enrollment Period

1.5 years

First QC Date

December 18, 2012

Last Update Submit

December 26, 2012

Conditions

Coronary CatheterizationTransradial Patency

Keywords

Coronary catheterizationTransradial patency

Outcome Measures

Primary Outcomes (1)

  • Normal reverse Allen test

    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.

    Within 2 years of the initial procedure

Secondary Outcomes (1)

  • Antegrade flow in the radial artery by ultrasound

    Within 2 years of the initial procedure

Study Arms (1)

Study cohort

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Previous transradial catheterization with a 7F vascular sheath

You may not qualify if:

  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical Center

Haifa, 34362, Israel

Location

Related Publications (5)

  • Amoroso G, Kiemeneij F. Transradial access for primary percutaneous coronary intervention: the next standard of care? Heart. 2010 Sep;96(17):1341-4. doi: 10.1136/hrt.2010.196824.

    PMID: 20801852BACKGROUND

  • Freestone B, Nolan J. Transradial cardiac procedures: the state of the art. Heart. 2010 Jun;96(11):883-91. doi: 10.1136/hrt.2007.134213. No abstract available.

    PMID: 20478867BACKGROUND

  • Bertrand OF, Rao SV, Pancholy S, Jolly SS, Rodes-Cabau J, Larose E, Costerousse O, Hamon M, Mann T. Transradial approach for coronary angiography and interventions: results of the first international transradial practice survey. JACC Cardiovasc Interv. 2010 Oct;3(10):1022-31. doi: 10.1016/j.jcin.2010.07.013.

    PMID: 20965460BACKGROUND

  • Pancholy SB, Patel TM. Effect of duration of hemostatic compression on radial artery occlusion after transradial access. Catheter Cardiovasc Interv. 2012 Jan 1;79(1):78-81. doi: 10.1002/ccd.22963. Epub 2011 May 16.

    PMID: 21584923BACKGROUND

  • Uhlemann M, Mobius-Winkler S, Mende M, Eitel I, Fuernau G, Sandri M, Adams V, Thiele H, Linke A, Schuler G, Gielen S. The Leipzig prospective vascular ultrasound registry in radial artery catheterization: impact of sheath size on vascular complications. JACC Cardiovasc Interv. 2012 Jan;5(1):36-43. doi: 10.1016/j.jcin.2011.08.011.

    PMID: 22230148BACKGROUND

Study Officials

  • Ronen Jaffe, MD

    Carmel Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronen Jaffe, MD

CONTACT

972-50-6265830jaffe@clalit.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2012

First Posted

December 20, 2012

Study Start

January 1, 2013

Primary Completion

July 1, 2014

Study Completion

January 1, 2015

Last Updated

December 27, 2012

Record last verified: 2012-12

Locations

IL(1)