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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vascular Closure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Angio-Seal VIP Vascular Closure

Angio-Seal VIP 6 French (6F) and 8 French (8F) devices

Intervention Type DEVICE

These devices are used for the vascular closure procedure

Interventions

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Angio-Seal VIP 6 French (6F) and 8 French (8F) devices

These devices are used for the vascular closure procedure

Intervention Type DEVICE

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No