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WithdrawnNCT00825331Updated Sep 23, 2015

Improvement of Periprocedural Guidewire Management for Cardiac Catheterization (PTCA)

An observational study in Cardiac Catheterization, sponsored by RWTH Aachen University. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-23.

Sponsored by RWTH Aachen University · Observational

Why this study was withdrawn
Change of location for Investigators
Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

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Conditions studied

  • Cardiac Catheterization

Keywords

  • guide wire
  • cardiac catheterization
  • ultrasound-guided examination of the access site
  • graduated scheme
  • elective and non elective cardiac catheterization
03

In context

Lead sponsor

RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients needing elective cardiac catheterization or PCI or emergency interventions

Inclusion criteria

  • elective cardiac catheterization or PCI or emergency interventions

Exclusion criteria

Exclusion Criteria:

-

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Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Decrease of vascular complications by marking of the access site

    Time frame: 18 months

Secondary outcomes

  1. Improvement of guide wire removal procedure by using the graduated scheme

    Time frame: 18 months

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Study locations

1 site
  • Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
    Aachen, NRW 52074, Germany
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References and documents

Publications

  • Stegemann E, Busch L, Stegemann B, Lauer T, Hoffmann R, Heiss C, Kelm M. Evaluation of a structured training program for arterial femoral sheath removal after percutaneous arterial catheter procedures by assistant personnel. Am J Cardiol. 2015 Apr 1;115(7):879-83. doi: 10.1016/j.amjcard.2015.01.012. Epub 2015 Jan 15. PubMed 25661570 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00825331
Lead sponsor
RWTH Aachen University
Responsible party
Sponsor
First posted
Jan 21, 2009
Start date
Jan 2009
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Sep 23, 2015

Study contacts

Emilia Stegemann, MD
principal investigator · RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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