St. Jude Medical Angio-Seal VIP Vascular Closure Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Patients Requiring a Diagnostic and/or Interventional Diagnostic Procedure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Angio-Seal VIP

Group Type OTHER

Angio-Seal VIP

Intervention Type DEVICE

Vascular Closure Device

Interventions

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Angio-Seal VIP

Vascular Closure Device

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No