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

NCT01858636 | Completed Results

• 1 other identifier: CL06818
• Study Type: observational
• Target: 235
• Locations: 2 countries
• Sites: 6

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.

Conditions

Vascular Closure

Outcome Measures

Primary Outcomes (2)

• 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

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

  within 5 minutes of device deployment

Study Arms (1)

Angio-Seal VIP Vascular Closure

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

Interventions

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

These devices are used for the vascular closure procedure

Angio-Seal VIP Vascular Closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (6)

Kerckhoff-Klinik GmbH

Bad Nauheim, Germany

Location

Institut für Diagnostiche und Interventionelle Radiologie

Frankfurt, Germany

Location

Univ. des Saarlandes

Homburg, Germany

Location

Herzzentrum Leipzig GMBH

Leipzig, Germany

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

MeSH Terms

Interventions

Equipment and Supplies

Results Point of Contact

• Title: Andrew Campbell
• Organization: St. Jude Medical

acampbell2@sjm.com

+1.651.756.5538

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 21, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 5, 2019
• Results First Posted: November 18, 2014

Record last verified: 2019-02

Locations

NL (2); DE (4)