Assessment of Radial Artery Patency Following Catheterization With a 7F Sheath
This study is not yet open for participant recruitment.
Verified December 2012 by Jaffe, Ronen, M.D.
Sponsor:
Jaffe, Ronen, M.D.
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
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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 |
| 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
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 May 21, 2013