Angio-Seal Evolution Device Registry

Abbott Medical Devices1,004 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

1,004

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Good Samaritan Hospital

Los Angeles, California, United States

Michigan Heart, P.C.

Ypsilanti, Michigan, United States

Cooper Health System

Camden, New Jersey, United States

Outcomes

Primary Outcomes

Collect major vascular complications

Time frame: 30 days post-procedure

Secondary Outcomes

Assess time artery stops bleeding

Time frame: Immediately following procedure

Collect minor vascular complications

Time frame: 30 days post-procedure

Data from ClinicalTrials.gov

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