Safety and Performance Study of Large Hole Vascular Closure Device

NCT01943344 | Completed Results DMC

• 2 other identifiers: P043-00EUDAMED: CIV-IE-13-01-009581
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Clinical Investigation is to gather feasibility data on the clinical use of the VIVASURE CLOSURE DEVICE™ in relation to safety, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures.

Conditions

Percutaneous Closure of Arteriotomy in Common Femoral Artery

Keywords

vascular large hole closure; arteriotomy closure; Large hole vascular closure device; vascular closure device; percutaneous vascular closure device

Outcome Measures

Primary Outcomes (1)

• Major Vascular Complications Directly Related to Device

  Major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, (as defined by VARC-2).

  up to 3 Months of implantation

Secondary Outcomes (1)

• Minor Vascular Complications Directly Related to Device

  up to 3 months from implantation

Other Outcomes (1)

• Performance

  up to 3 month of implantation

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects that receive VIVASURE CLOSURE DEVICE™

Device: VIVASURE CLOSURE DEVICE™

Interventions

VIVASURE CLOSURE DEVICE™ DEVICE

implantation of VIVASURE CLOSURE DEVICE™

Also known as: DP2, DP2-FA1-1

Treatment

Eligibility Criteria

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

You may qualify if:

• Over 18 years of age.
• Each patient, or his or her guardian or legal representative, is willing to give informed consent.
• Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 - 24 F.
• Females who are not pregnant or lactating, and not planning to become pregnant ≤ 12 months. A pregnancy test may be performed to confirm this.

You may not qualify if:

• Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year.
• Evidence of systemic bacterial or cutaneous infection, including groin infection.
• Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) and/or VRE (vancomycin-resistant Enterococci) colonisation.
• With arterial access other than the common femoral artery.\*
• Patients suffering with definitive or potential coagulopathy or platelet count less than 100,000/µl.
• Patient with a haematocrit of less than 32 %.
• A measured activated clotting time (ACT) of greater than 350 seconds immediately prior to sheath removal.\*
• If patients are expected to be continuously treated with anticoagulation therapy post-procedure such that their ACT reading is expected to be elevated above 350 seconds for more than 24 hours after the procedure.
• Evidence of arterial diameter stenosis greater than 20 % within 20 mm of the arteriotomy.\*
• Circumferential calcification within 20 mm of the arteriotomy.\*
• Use of systemic thrombolytic agents within 24 hours prior to or during the catheterisation procedure which cause the concentration of fibrinogen to be less than 100 mg/dl.
• Patients in which the arteriotomy is less than 18 F or greater than 24 F.\*
• Known allergy to any of the materials used in the device (Refer to Instructions for Use).
• Currently enrolled in any other investigational clinical study, where the primary endpoint has not yet been achieved.
• Patients judged unsuitable for surgical repair of the access site.

Sponsors & Collaborators

• Vivasure Medical Limited: lead

Study Sites (1)

St Jame's Hospital

Dublin, Ireland

Location

Results Point of Contact

• Title: Dr Chris Martin
• Organization: Vivasure Medical

chris.martin@vsuremed.com

+353 9 395 440

Study Officials

• Dr Peter Crean, FRCPI MB ChB

  St Jame's Hospital, Dublin

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: September 16, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: May 1, 2015
• Last Updated: November 2, 2018
• Results First Posted: July 6, 2016

Record last verified: 2018-01

Locations

IE (1)