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OpenTrials
Completed

NCT Number: NCT01858636

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

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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Key information

Conditions

Vascular Closure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kerckhoff-Klinik GmbH, Bad Nauheim, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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

Device

These devices are used for the vascular closure procedure

Primary outcomes

  1. The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication

    Time frame: 30 days post procedure

    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)

  2. The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.

    Time frame: within 5 minutes of device deployment

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: SEAL PM

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 21, 2013
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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