St. Jude Medical Angio-Seal VIP Vascular Closure Device

NCT01393041 | Completed

• 1 other identifier: 0901
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patients Requiring a Diagnostic and/or Interventional Diagnostic Procedure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (1)

Angio-Seal VIP

OTHER

Device: Angio-Seal VIP

Interventions

Angio-Seal VIP DEVICE

Vascular Closure Device

Angio-Seal VIP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Klinikum Luedenscheid

Lüdenscheid, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: July 13, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

DE (1)