Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device (SEAL PM)

To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis.

Study Overview

• Status: Completed
• Conditions: Vascular Closure
• Intervention / Treatment: Device: Angio-Seal VIP 6 French (6F) and 8 French (8F) devices

• Study Type: Observational
• Enrollment (Actual): 235

Contacts and Locations

Study Locations

• Germany
  • Bad Nauheim, Germany
    • Kerckhoff-Klinik GmbH
  • Frankfurt, Germany
    • Institut für Diagnostiche und Interventionelle Radiologie
  • Homburg, Germany
    • Univ. des Saarlandes
  • Leipzig, Germany
    • Herzzentrum Leipzig GmbH
• Netherlands
  • Breda, Netherlands
    • Amphia ziekenhuis
  • Enschede, Netherlands
    • Medisch Spectrum Twente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that will be included in the study will be indicated for the procedure according to the Instructions for Use. Physicians should carefully select patients based on the IFU including a consideration of all warnings and precautions.

Description

Inclusion Criteria:

• Patient requires closure of femoral artery puncture resulting from arterial access procedure.
• Patient is ≥18 years of age.
• Patient is willing to provide written informed consent prior to study device use.
• Patient is willing and able to adhere to data collection and follow-up requirements.

Exclusion Criteria:

• Patient is participating in another clinical trial which has the potential to impact hemostasis.
• Patient has an active groin infection or systemic infection.
• Patient has undergone a vascular access procedure within the past 90 days.
• Patient has been previously enrolled in the study. (For patients undergoing multiple interventions within a timeframe of 90 days, only the initial procedure may constitute a study enrollment.)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Angio-Seal VIP Vascular Closure	Device: Angio-Seal VIP 6 French (6F) and 8 French (8F) devices; These devices are used for the vascular closure procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication	Major vascular complications include: Access Site Complications: Hematoma >10 cm in size requiring surgical or percutaneous intervention; Major bleeding requiring transfusion of ≥2 units of blood or requiring surgical or percutaneous intervention; Pain requiring a hospitalization extended for more than 24 hours or a new hospitalization, or percutaneous or surgical intervention; Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with IV antibiotics; A/V Fistula requiring medical intervention (percutaneous or surgical); Pseudoaneurysm requiring medical intervention (percutaneous or surgical) b. Lower Limb Ischemia requiring surgical or medical intervention or resulting in permanent injury/impairment c. Retroperitoneal hemorrhage requiring intervention (percutaneous or surgical)	30 days post procedure
The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.		within 5 minutes of device deployment

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimate): May 21, 2013

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

• Other Study ID Numbers: CL06818