Differences in Radial Artery Occlusion From Two Different Compressive Methods Used in Patients in Order to Achieve Homeostasis After Transradial Catheterization and Their Repercussion in Artery Functionality and Hand Mobility
NCT ID: NCT02697526
Last Updated: 2016-03-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
274 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-01-31
Study Completion Date
2008-05-31
Brief Summary
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The aim of the study is to determine differences on radial artery occlusion from two compressive methods used after transradial catheterization and its functional impact on hand mobility.
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Detailed Description
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Changes in Allen's test and pulse oximetry will be evaluated at baseline, 1 week and 3 month of catheterization in both groups of patients in order to check the functionality of the communications between the ulnar and radial arteries. The repercussion of each compressive method on radial occlusion and artery revascularization will be assessed by eco-Doppler at any time. Changes in diameter of arterial lumen of radial and ulnar arteries as a consequence of radial occlusion will be done simultaneously of blood flow Doppler measurements. The possible impact of radial occlusion on hand mobility will be done using a dynamometer designed to evaluate strength (Endurance test) and muscular claudication (Rapid exchange test).
Conditions
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Transradial Catheterization
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Blinding Strategy
NONE
Study Groups
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Terumo
Patients in this arm will receive Terumo after catheterization
Group Type
OTHER
Terumo
Intervention Type
OTHER
Tensoplast
Patients in this arm will receive Tensoplast after catheterization
Group Type
OTHER
Tensoplast
Intervention Type
OTHER
Interventions
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Terumo
Intervention Type
OTHER
Tensoplast
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Patients in whom at least the diagnostic catheterization has been done successfully by the radial artery route.
* Patients with a negative Allen's Clinical test showing hyperemia before 9 seconds after pressure release over the ulnar artery pulse.
* Patients showing a Barbeau pattern A,B or C with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
* Patients that will be able to do the follow up visits at 1 week and 3 month.
* Signature of informed consent
* Patients with a negative Allen's Clinical test showing hyperemia before 9 seconds after pressure release over the ulnar artery pulse.
* Patients showing a Barbeau pattern A,B or C with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
* Patients that will be able to do the follow up visits at 1 week and 3 month.
* Signature of informed consent
Exclusion Criteria
* Patients in that neither the diagnostic or therapeutic procedure has successfully done via the radial artery route.
* Patients with a positive Allen's test (no hyperemia) after pressure and release over the ulnar artery pulse.
* Patients showing a Barbeau pattern D with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
* Inability to visit at 1 week and 3 month.
* Impossibility to obtain informed consent form
* Patients with a positive Allen's test (no hyperemia) after pressure and release over the ulnar artery pulse.
* Patients showing a Barbeau pattern D with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
* Inability to visit at 1 week and 3 month.
* Impossibility to obtain informed consent form
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Bruno García del Blanco, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Vall d'Hebron (Barcelona)
Locations
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Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Site Status
Countries
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Spain
References
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Reference Type
BACKGROUND
Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 10.1056/NEJMoa1503943. Epub 2015 Oct 14.
Reference Type
BACKGROUND
Valsecchi O, Vassileva A, Musumeci G, Rossini R, Tespili M, Guagliumi G, Mihalcsik L, Gavazzi A, Ferrazzi P. Failure of transradial approach during coronary interventions: anatomic considerations. Catheter Cardiovasc Interv. 2006 Jun;67(6):870-8. doi: 10.1002/ccd.20732.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PR(AG)70/2006
Identifier Type: -
Identifier Source: org_study_id
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