- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00825331
Improvement of Periprocedural Guidewire Management for Cardiac Catheterization (PTCA)
Improvement of Periprocedural Guidewire Management for Cardiac Catheterization (PTCA)Using Preprocedural Marking of the Arterial Access Site and a Graduated Scheme for Removal of the Guidewire
Study Overview
Status
Conditions
Detailed Description
Before elective cardiac catheterization, patients undergo an ultrasound-guided marking of the bifurcation of the common femoral artery in order to access the vascular complication rate compared tho those of non-marked patients.
Concerning the removal of the guided wire, patients will be treated due to a graduated scheme taking care of different risk levels. This procedure should improve clinical routine, but the efficacy and safety have to be assessed. Depending on the risk level, the guide wire will be removed either by an ambulance officer or emergency medical technician, assistant personal of the cardiac catheterization operating room or by a physician specialist in intensive care. Both methods should lead to quality assurance.
Study Type
Contacts and Locations
Study Locations
-
-
NRW
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Aachen, NRW, Germany, 52074
- Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- elective cardiac catheterization or PCI or emergency interventions
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
1
patients for elective catheterization without special risks
|
2
patients for elective catheterization with special risks
|
3
patients for PCI without GP IIb/IIIa
|
4
Patients for PCI with GPIIb/IIIa and emergencies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decrease of vascular complications by marking of the access site
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement of guide wire removal procedure by using the graduated scheme
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emilia Stegemann, MD, RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Guidewire Management for PTCA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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