Clinical trial NCT01222104: Angio-Seal Interventional Radiology (IR) Registry
Official title: Clinical Registry of St. Jude Medical Angio-Seal™ Vascular Closure Devices Following Interventional Radiology Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnostic and/or Interventional Radiology Procedures
Keywords: vascular closure
Angio-Seal
Interventional radiology
femoral artery
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 634
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who undergo a diagnostic and/or interventional radiology procedure through percutaneous femoral artery access and meet the registry selection criteria.

Brief summary: The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient populations.


Eligibility criteria: Inclusion Criteria:

1. Patient is undergoing a diagnostic and/or interventional radiology procedure via femoral arterial access and the investigator performing the procedure would use Angio-Seal for closure as part of his/her routine care of the patient. Angio-Seal deployment will follow the standard of care for vascular closure device use and the Instructions for Use (IFU) for the device.
2. Sheath angiography prior to Angio-Seal deployment reveals appropriate anatomy and puncture location for vascular closure device deployment.

Exclusion Criteria:

1. Patients who are unable to provide written informed consent.

Primary outcomes:
measure: Rate of Major Vascular Complications
timeFrame: 30 days
Secondary outcomes:
measure: Time to Hemostasis
timeFrame: Procedure
measure: Rate of Minor Vascular Complications
timeFrame: 30 days
measure: Impact of Guided Access on Use of Closure Device.
timeFrame: 30 days
measure: Impact of Guided Access on Achieving Target Puncture Location.
timeFrame: 30 days
measure: Rate of Major Vascular Complications (MVCs) by Guided Access Mode.
timeFrame: 30 days
measure: Rate of Minor Vascular Complications by Guided Access Mode.
timeFrame: 30 days
measure: Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device
timeFrame: 30 days
measure: Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device
timeFrame: 30 days
measure: Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD)
timeFrame: 30 days
measure: Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD)
timeFrame: 30 days
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Buffalo
country: United States
facility: Kaleida Health
state: New York
city: Cincinnati
country: United States
facility: Mayfield Clinic, Inc.; The University Hospital
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
Study officials:
affiliation: Cooper University
name: Zoltan Turi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: