Angio-Seal Evolution Device Registry | NCT00817349

Studies
Angio-Seal Evolution Device Registry

NCT00817349

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Feb 4, 2019Actual

Enrollment

1,004Actual

Phase

Not provided

Conditions

Peripheral Vascular Disease
Coronary Artery Disease
Peripheral Artery Disease
Arterial Occlusive Disease
Coronary Heart Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Jan 5, 2009

First Submission Date that Met QC Criteria

Jan 5, 2009

First Posted Date

Jan 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This multi-center clinical registry is designed to collect data on the use of the Angio-Seal Evolution Device in patients who have had diagnostic and/or interventional procedures through femoral artery access. Data will be collected on a patient's initial screening through hospital discharge and 30 days post-procedure to evaluate major and minor vascular complications as defined in the protocol.

Conditions Module

Conditions

Peripheral Vascular Disease
Coronary Artery Disease
Peripheral Artery Disease
Arterial Occlusive Disease
Coronary Heart Disease

Keywords

Angio-Seal
Peripheral vascular disease
Vascular closure device
Arterial closure
Coronary artery disease
Arterial hemostasis
Coronary cardiac catheterization
Percutaneous coronary intervention
Interventional catheterization
Diagnostic catheterization
Common femoral artery
Manual compression
Vascular intervention
Angiogram
Coronary intervention
Coronary angioplasty
Angiography
Arteriotomy
Vascular access

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,004Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collect major vascular complications		30 days post-procedure

Secondary Outcomes

Measure	Description	Time Frame
Assess time artery stops bleeding		Immediately following procedure
Collect minor vascular complications		30 days post-procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients who are unable to provide written informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Those needing a diagnostic and/or interventional catheterization procedure.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Applegate, MD	Wake Forest University Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Good Samaritan Hospital		Los Angeles	California	90017	United States
Michigan Heart, P.C.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20814049	Derived	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.

ID	Term
D016491	Peripheral Vascular Diseases
D003324	Coronary Artery Disease
D058729	Peripheral Arterial Disease
D001157	Arterial Occlusive Diseases
D003327	Coronary Disease

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D017202	Myocardial Ischemia
D006331	Heart Diseases