Angio-Seal Interventional Radiology (IR) Registry

Clinical Registry of St. Jude Medical Angio-Seal™ Vascular Closure Devices Following Interventional Radiology Procedures

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.

Study Overview

• Status: Completed
• Conditions: Diagnostic and/or Interventional Radiology Procedures

• Study Type: Observational
• Enrollment (Actual): 634

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Miami, Florida, United States, 33176
      • Baptist Cardiac and Vascular Institute
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • New York
    • Buffalo, New York, United States, 14209
      • Kaleida Health
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Mayfield Clinic, Inc.; The University Hospital
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Angio-Seal; Angio-Seal attempted and/or deployed
Not deployed; Other method of closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Major Vascular Complications	Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure. The following are defined as a major vascular complication: Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means;; Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention;; Access site related bleeding requiring transfusion;; New ipsilateral lower extremity ischemia requiring surgical intervention;; Retroperitoneal bleeding;; Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics;; Access related complication that results in extended hospital stay;; Death	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Hemostasis	Time-to-hemostasis stratified into 3 categories: hemostasis in less than 1 minute alone or in combination with manual compression (standard of care), 1-5 minutes alone or in combination with manual compression (standard of care), and/or hemostasis achieved >5 minutes and/or with additional hemostasis methods required.	Procedure
Rate of Minor Vascular Complications	The following are defined as a minor vascular complication: Unanticipated access site bleeding requiring ≥ 30 minutes of manual compression to re-achieve hemostasis;; Ipsilateral hematoma >10 cm;; Ipsilateral pseudoaneurysm without intervention;; Ipsilateral arteriovenous fistula;; Ipsilateral deep vein thrombosis;; Local access site infection without prolonged hospitalization	30 days
Impact of Guided Access on Use of Closure Device.	The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device.	30 days
Impact of Guided Access on Achieving Target Puncture Location.	The influence of fluoroscopy and/or ultrasound guided access on puncture location.	30 days
Rate of Major Vascular Complications (MVCs) by Guided Access Mode.	The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs).	30 days
Rate of Minor Vascular Complications by Guided Access Mode.	The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications.	30 days
Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device	Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device	30 days
Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device	Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved.	30 days
Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD)	Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC).	30 days
Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD)	Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications.	30 days

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Zoltan Turi, M.D., Cooper University

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: October 5, 2010
• First Submitted That Met QC Criteria: October 14, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: vascular closure; femoral artery; Angio-Seal; Interventional radiology
• Other Study ID Numbers: 0903 (Adult Brain Tumor Consortium)