St. Jude Medical Angio-Seal VIP Vascular Closure Device

Clinical Study of the St. Jude Medical Angio-Seal VIP Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures

The purpose of this clinical study is to assess device deployment characteristics and performance, as well as adverse events (vascular complications) of the SJM Angio-Seal VIP 6 French device utilizing the SJM collagen.

Study Overview

• Status: Completed
• Conditions: Patients Requiring a Diagnostic and/or Interventional Diagnostic Procedure
• Intervention / Treatment: Device: Angio-Seal VIP

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Luedenscheid, Germany
    • Klinikum Luedenscheid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is undergoing a diagnostic and/or interventional endovascular procedure via a retrograde femoral arterial access.
2. Patient is of legal age.
3. Patient has given written informed consent for participation prior to the procedure.
4. Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements.

Exclusion Criteria:

1. Patient is unable to provide written informed consent.
2. Patient has an inability or is unwilling to adhere to data collection and follow-up requirements.
3. Patients who are pregnant or lactating.
4. Patient may not participate in another clinical trial which has the potential to impact hemostasis (pharmaceutical/ device/ homeopathic).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Angio-Seal VIP	Device: Angio-Seal VIP; Vascular Closure Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device deployment characteristics and performance	Device Deployment Success and rationale for non-deployment, procedural circumstances present during deployment such as type of procedure and procedure duration, Time to hemostasis, and assessment of vascular complications prior to leaving the cath lab. Data will be summarized using descriptive statistics in addition to listings or summary data tables being provided.	At procedure
Adverse events (vascular complications)	Adverse events (vascular complications) out to 30 days post-procedure on patients who have undegone a diagnostic and/or interventional procedure.	Ongoing

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to hemostasis	The time elapsed from device deployment (cutting of the suture) to complete cessation of arterial bleeding, stratified as hemostasis in less than 1 minute, 1-5 minutes, or greater than 5 minutes.
Rate of minor vascular complications	Ongoing

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimate): July 13, 2011

Study Record Updates

• Last Update Posted (Actual): February 4, 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: 0901 (Ethikkommision KiKli BE)