Angio-Seal Evolution Device Registry

Clinical Registry of the St. Jude Medical Angio-Seal(TM) Evolution(TM) Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00817349

Enrollment

1004

Registered

2009-01-06

Start date

2008-07-31

Completion date

2010-04-30

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Collect major vascular complications	30 days post-procedure

Secondary

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

Countries

United States

Outcome results