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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.

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
NameTimeMethod
Collect major vascular complications30 days post-procedure
Secondary Outcome Measures
NameTimeMethod
Assess time artery stops bleedingImmediately following procedure
Collect minor vascular complications30 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

Good Samaritan Hospital
🇺🇸Los Angeles, California, United States

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