ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT01858636CL06818NCT01858636Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device
SEAL PM
Abbott Medical DevicesIndustryNo
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.
CompletedMay 2013October 2013October 2013ObservationalNoCohortProspectiveThe Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication30 days post procedureMajor 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)The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.within 5 minutes of device deployment1235Vascular ClosureAngio-Seal VIP Vascular ClosureDeviceAngio-Seal VIP 6 French (6F) and 8 French (8F) devicesThese devices are used for the vascular closure procedureAngio-Seal VIP Vascular Closure
Patients that will be included in the study will be indicated for the procedure according
to the Instructions for Use. Physicians should carefully select patients based on the IFU
including a consideration of all warnings and precautions.
Non-Probability Sample
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.)
All18 YearsN/ANoKerckhoff-Klinik GmbHBad NauheimGermanyInstitut für Diagnostiche und Interventionelle RadiologieFrankfurtGermanyUniv. des SaarlandesHomburgGermanyHerzzentrum Leipzig GMBHLeipzigGermanyAmphia ZiekenhuisBredaNetherlandsMedisch Spectrum TwenteEnschedeNetherlandsGermanyNetherlandsFebruary 2019May 14, 2013May 16, 2013May 21, 2013October 24, 2014November 17, 2014November 18, 2014February 1, 2019February 1, 2019February 5, 2019Sponsor