NCT00825331

Brief 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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

4.9 years

First QC Date

January 19, 2009

Last Update Submit

September 22, 2015

Conditions

Cardiac Catheterization

Keywords

guide wirecardiac catheterizationultrasound-guided examination of the access sitegraduated schemeelective and non elective cardiac catheterization

Outcome Measures

Primary Outcomes (1)

  • Decrease of vascular complications by marking of the access site

    18 months

Secondary Outcomes (1)

  • Improvement of guide wire removal procedure by using the graduated scheme

    18 months

Study Arms (4)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients needing elective cardiac catheterization or PCI or emergency interventions

You may qualify if:

  • elective cardiac catheterization or PCI or emergency interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25661570DERIVED

Study Officials

  • Emilia Stegemann, MD

    RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2009

First Posted

January 21, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

DE(1)