NCT00590798

Brief Summary

To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely ambulate within 30 minutes of catheterization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2007

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

April 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 10, 2013

Status Verified

April 1, 2013

Enrollment Period

1.7 years

First QC Date

December 26, 2007

Last Update Submit

April 9, 2013

Conditions

Cardiovascular Disease

Keywords

Cardiac CatheterizationWalkHeart CatheterizationCoronary DiseaseHeart DiseaseCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Occurrence or absence of adverse outcomes after ambulation within 30 minutes of cardiac catheterization

    7 days post procedure

Study Arms (1)

1

EXPERIMENTAL

Patients are asked to walk within 30 minutes after implantation of the Star- Close vascular closure system.

Behavioral: Walking

Interventions

WalkingBEHAVIORAL

Patient will walk within 30 minutes of vascular closure system procedure

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to for an outpatient left heart catheterization
  • Catheterization through the femoral artery
  • Able to ambulate at least 20 feet
  • Able to receive the Star-Close Vascular Closure System
  • Be a candidate for hospital discharge following catheterization

You may not qualify if:

  • Known peripheral arterial disease
  • Blood pressure greater than 180/110
  • Pregnant or lactating
  • Anemic or low blood count
  • Blood thinning medication within 5 days before catheterization
  • Unable to walk 20 feet with out rest
  • Complications during catheterization procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesCoronary Artery Disease

Interventions

Walking

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Earnest L Mazzaferri Jr, MD

    The Ohio State University Medical Center, Division of Cardiovascular Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Study Start

April 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 10, 2013

Record last verified: 2013-04

Locations

US(1)