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

Vascular Closure Clinical Trial

— SEAL PM  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858636
• Other study ID #: CL06818
• Status: Completed
• Start date: May 2013
• Est. completion date: October 2013

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Vascular Closure

Intervention

Device:
• Angio-Seal VIP 6 French (6F) and 8 French (8F) devices
These devices are used for the vascular closure procedure

Locations

Country	Name	City	State
Germany	Kerckhoff-Klinik GmbH	Bad Nauheim
Germany	Institut für Diagnostiche und Interventionelle Radiologie	Frankfurt
Germany	Univ. des Saarlandes	Homburg
Germany	Herzzentrum Leipzig GMBH	Leipzig
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Medisch Spectrum Twente	Enschede

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication	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)	30 days post procedure
Primary	The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.		within 5 minutes of device deployment