Angio-Seal Evolution Device Registry

Completed

• Conditions: Peripheral Vascular Disease; Coronary Artery Disease; Peripheral Artery Disease; Arterial Occlusive Disease; Coronary Heart Disease

• Registration Number: NCT00817349
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-01-05
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1004

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collect major vascular complications	30 days post-procedure

Secondary Outcome Measures

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

Trial Locations

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

Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Altru Health System Hospital; 🇺🇸 Grand Forks, North Dakota, United States

Ohiohealth Research Institute @ Riverside Methodist Hospital; 🇺🇸 Columbus, Ohio, United States

Providence Health & Services; 🇺🇸 Portland, Oregon, United States

Main Line Health Heart Center: Bryn Mawr Hospital; 🇺🇸 Bryn Mawr, Pennsylvania, United States

Main Line Health Heart Center: Lankenau Hospitals; 🇺🇸 Wynnewood, Pennsylvania, United States

Baptist Hospital West; 🇺🇸 Knoxville, Tennessee, United States