NCT00842179

Brief Summary

The objective of this study is to compare groin complication rates in low and high risk patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose vascular closure device (VCD) or manual compression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,517

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

4 months

First QC Date

February 6, 2009

Last Update Submit

February 11, 2009

Conditions

Vascular Closure

Keywords

Perclose

Outcome Measures

Primary Outcomes (1)

  • major vascular complications

    0-30 days (during Index hospitalization)

Secondary Outcomes (1)

  • Minor vascular complications

    0-30 days (during index hospitalization)

Study Arms (2)

Manual Closure

Patients who received vascular closure with manual compression after percutaneous coronary intervention (PCI)

Perclose Device

Patients who received vascular closure with the Perclose VCD after percutaneous coronary intervention (PCI)

Eligibility Criteria

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

Patients who require vascular closure post percutaneous coronary intervention

You may qualify if:

  • Patients who received vascular closure with the Perclose device post PCI at Baptist Miami Hospital
  • Patients who received vascular closure by manual compression at Tampa General Hospital

You may not qualify if:

  • Patients less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Study Officials

  • Jonathan Roberts, MD

    Baptist Health South Florida

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 12, 2009

Study Start

June 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 12, 2009

Record last verified: 2009-02

Locations

US(1)