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NCT00825331 Clinical Trial

Improvement of Periprocedural Guidewire Management for Cardiac Catheterization (PTCA)

Cardiac Catheterization Clinical Trial

Official title:
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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00825331
Other study ID # Guidewire Management for PTCA
Secondary ID
Status Withdrawn
Phase N/A
First received January 19, 2009
Last updated September 22, 2015
Start date January 2009
Est. completion date December 2013

Study information
Verified date September 2015
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

Periprocedural management of guidewire placement and removal in patients needing cardiac catheterization by use of marking of the access site and removal procedure due to a graduated scheme

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- elective cardiac catheterization or PCI or emergency interventions

Exclusion Criteria:

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine Aachen NRW

Sponsors (1)
Lead Sponsor Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Decrease of vascular complications by marking of the access site 18 months No
Secondary Improvement of guide wire removal procedure by using the graduated scheme 18 months No
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