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

Completed

• Conditions: Vascular Closure
• Interventions: Device: Angio-Seal VIP 6 French (6F) and 8 French (8F) devices

• Registration Number: NCT01858636
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-21
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2014-10-24
• Results First Submitted QC: 2014-11-17
• Results First Posted: 2014-11-18
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Angio-Seal VIP Vascular Closure	Angio-Seal VIP 6 French (6F) and 8 French (8F) devices	-

Primary Outcome Measures

Name	Time	Method
The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication	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)
The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.	within 5 minutes of device deployment

Trial Locations

Locations (6)

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Herzzentrum Leipzig GMBH; 🇩🇪 Leipzig, Germany

Institut für Diagnostiche und Interventionelle Radiologie; 🇩🇪 Frankfurt, Germany

Kerckhoff-Klinik GmbH; 🇩🇪 Bad Nauheim, Germany

Univ. des Saarlandes; 🇩🇪 Homburg, Germany

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands