Angio-Seal Interventional Radiology (IR) Registry

Abbott Medical Devices634 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

634

Conditions

Diagnostic and/or Interventional Radiology Procedures

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (10)

Loma Linda University Medical Center

Loma Linda, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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: 1. Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means; 2. Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention; 3. Access site related bleeding requiring transfusion; 4. New ipsilateral lower extremity ischemia requiring surgical intervention; 5. Retroperitoneal bleeding; 6. Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics; 7. Access related complication that results in extended hospital stay; 8. Death

Time frame: 30 days

Secondary Outcomes

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.

Time frame: Procedure

Rate of Minor Vascular Complications

The following are defined as a minor vascular complication: 1. Unanticipated access site bleeding requiring ≥ 30 minutes of manual compression to re-achieve hemostasis; 2. Ipsilateral hematoma \>10 cm; 3. Ipsilateral pseudoaneurysm without intervention; 4. Ipsilateral arteriovenous fistula; 5. Ipsilateral deep vein thrombosis; 6. Local access site infection without prolonged hospitalization

Time frame: 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.

Data from ClinicalTrials.gov

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