NCT02788448

Brief Summary

The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures. This is a non-inferiority study based on safety. Safety will be assessed by incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE up to 3 months from implantation is no worse than those associated with cut-down and sutured close.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

May 25, 2016

Last Update Submit

January 30, 2018

Conditions

18 to 24 F Percutaneous Femoral Arteriotomy Closure

Keywords

Percutaneous vascular closure deviceLarge hole closure device

Outcome Measures

Primary Outcomes (1)

  • Major vascular complications [Safety]

    Incidence of major vascular complications directly related to study Device (as defined by VARC-2)

    up to 3 Months

Secondary Outcomes (2)

  • Minor vascular complications [Safety]

    up to 3 Months

  • Study device technical success rate [Performance]

    within 24 hours

Study Arms (1)

VIVASURE CLOSURE DEVICE

EXPERIMENTAL

Large hole closure device

Device: VIVASURE CLOSURE DEVICE

Interventions

VIVASURE CLOSURE DEVICEDEVICE

Large hole closure device

Also known as: DP2-FA1-2
VIVASURE CLOSURE DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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) 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 30 %.
  • 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 DP2 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.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Charité - Universitätsmedizin

Berlin, 10117, Germany

Location

University Hospital Leipzig

Leipzig, 04109, Germany

Location

St Franziskus Hospital

Münster, Germany

Location

Study Officials

  • Prof. Dr. med Giovanni Torsello, MD

    St Fraziskus Hospital, Muenster, Germany

    PRINCIPAL INVESTIGATOR

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

May 25, 2016

First Posted

June 2, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2017

Study Completion

November 1, 2017

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

DE(3)