NCT00817349

Brief Summary

Collect data on the use of the Angio-Seal Evolution Device in diagnostic and interventional patient populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,004

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

10 active sites

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

July 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

January 5, 2009

Last Update Submit

February 1, 2019

Conditions

Peripheral Vascular DiseaseCoronary Artery DiseasePeripheral Artery DiseaseArterial Occlusive DiseaseCoronary Heart Disease

Keywords

Angio-SealPeripheral vascular diseaseVascular closure deviceArterial closureCoronary artery diseaseArterial hemostasisCoronary cardiac catheterizationPercutaneous coronary interventionInterventional catheterizationDiagnostic catheterizationCommon femoral arteryManual compressionVascular interventionAngiogramCoronary interventionCoronary angioplastyAngiographyArteriotomyVascular access

Outcome Measures

Primary Outcomes (1)

  • Collect major vascular complications

    30 days post-procedure

Secondary Outcomes (2)

  • Assess time artery stops bleeding

    Immediately following procedure

  • Collect minor vascular complications

    30 days post-procedure

Eligibility Criteria

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

Those needing a diagnostic and/or interventional catheterization procedure.

You may qualify if:

  • Patient is having a diagnostic and/or interventional procedure via femoral artery access.

You may not qualify if:

  • Patients who are unable to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

Michigan Heart, P.C.

Ypsilanti, Michigan, 48197, United States

Location

Cooper Health System

Camden, New Jersey, 08103, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Altru Health System Hospital

Grand Forks, North Dakota, 58201, United States

Location

Ohiohealth Research Institute @ Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Providence Health & Services

Portland, Oregon, 97225, United States

Location

Main Line Health Heart Center: Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Main Line Health Heart Center: Lankenau Hospitals

Wynnewood, Pennsylvania, 19096, United States

Location

Baptist Hospital West

Knoxville, Tennessee, 37934, United States

Location

Related Publications (1)

  • Applegate RJ, Turi Z, Sachdev N, Ahmed A, Szyniszewski A, Foster M, Pratsos A, Shapiro T, Yakubov S, Shavelle D. The Angio-Seal Evolution registry: outcomes of a novel automated Angio-Seal vascular closure device. J Invasive Cardiol. 2010 Sep;22(9):420-6.

    PMID: 20814049DERIVED

MeSH Terms

Conditions

Peripheral Vascular DiseasesCoronary Artery DiseasePeripheral Arterial DiseaseArterial Occlusive DiseasesCoronary Disease

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesArteriosclerosisAtherosclerosis

Study Officials

  • Robert Applegate, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 6, 2009

Study Start

July 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

US(10)