NCT00838175

Brief Summary

Suture-mediated closure devices are effective and safe for achieving rapid hemostasis in femoral venous access site and reducing the incidence of complications associated with traditional closure methods. Furthermore, there are predictive factors(such as sheath size, obesity, procedure duration, and anticoagulation status)that we can use to assess the procedure's likelihood of success in various patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

1.7 years

First QC Date

February 4, 2009

Last Update Submit

February 5, 2009

Conditions

Cardiac Catheterization

Keywords

Peripheral Venous Catheterization

Outcome Measures

Primary Outcomes (1)

  • To determine the safety and effectiveness of the suture-mediated closure devices in closing femoral venous access sites.

    Within 30 days of procedure/closure

Secondary Outcomes (1)

  • To identify factors that are predictive of success and failure of the suture mediated closures.

    Within 30 days of procedure/closure

Study Arms (1)

1

All pts. who have undergone percutaneous intervention who received a suture-mediated closure of the venous access site will be screened for eligibility for this research trial.

Procedure: suture mediated closure

Interventions

suture mediated closurePROCEDURE

Suture mediated closure of femoral venous access

Also known as: Suture mediated closure of femoral venous access
1

Eligibility Criteria

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

Adult over the age of 18, who received a suture mediated closure of the femoral vein following catheterizaton at the BWH cath lab.

You may qualify if:

  • All consented pts. over the age of 18 who received sutured mediated femoral vein following catheterization

You may not qualify if:

  • Pt.s who are unable to give consent.
  • Pts. whose participation in research is contraindicated for medical reasons are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Andrew C Eisenhauer, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 6, 2009

Study Start

June 1, 2007

Primary Completion

February 1, 2009

Study Completion

May 1, 2009

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations

US(1)