Clinical trial NCT02241642: Safety and Performance Study of Large Hole Vascular Closure Device
Official title: Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Common Femoral Artery Arteriotomy Closure
Keywords: Percutaneous vascular closure device
vascular closure device
Large hole closure device
Lead sponsor: Vivasure Medical Limited
Sponsor class: INDUSTRY
First posted: 2014-09-16
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the VIVASURE CLOSURE DEVICE™. The study shall not be blinded prior to, during or post the procedure. All patients undergoing a procedure requiring an arteriotomy in the range of 18 to 24 F, via the common femoral artery will be screened against the inclusion/exclusion criteria. If the patient meets the requirements of the clinical investigation, they shall be invited to participate, provide informed consent and shall subsequently be assigned a subject number.

All subjects shall have an immediately post procedure, 24 hour, 1, 3 and 12 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee.

Eligibility criteria: Inclusion Criteria:

* 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 French (F)
* Females who are not pregnant or lactating, and not planning to become pregnant in ≤ 12 months

Exclusion Criteria:

* 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
* Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) and/or VRE (vancomycin-resistant Enterococci) colonisation
* 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
* Currently enrolled in any other investigational clinical study, whereby the primary endpoint has not yet been achieved
* Patients judged unsuitable for surgical repair of the access site
* If puncture site is via a vascular graft
* If there is any indication that the puncture has been made in the profunda femoris or located less than 10 mm above the profunda femoris
* Patients with a common femoral artery lumen diameter of less than 7 mm
* Patients that have a lower extremity amputation from the ipsilateral or contralateral limb
* Patients that have undergone a percutaneous procedure using a non-absorbable vascular closure device (excluding suture mediated) for haemostasis in the ipsilateral leg
* Patients that have undergone a percutaneous procedure greater than 8 F in the ipsilateral leg, within the previous 90 days
* Patients that have undergone a percutaneous procedure of 8 F or less using an absorbable intravascular closure device for haemostasis, in the ipsilateral leg, within the previous 90 days
* Patients that have undergone a percutaneous procedure of 8 F or less using a suture mediated closure device for haemostasis, in the ipsilateral leg, within the previous 30 days
* Patients that have undergone a percutaneous procedure of 8 F or less using manual/mechanical pressure for haemostasis in the ipsilateral leg, within the previous 30 days
* Patients with an acute haematoma of any size, arteriovenous fistula or Pseudoaneurysm at the access site
* Significant blood loss/transfusion during interventional procedure or within 20 days of procedure requiring transfusion of greater than 4 units of blood
* Angiographic evidence of arterial laceration, dissection or stenosis within the external iliac or femoral artery before the use of the VCD
* Severe claudication, stenosis of the iliac artery \> 50% or previous bypass surgery/stent placement in the region of the vascular access

Primary outcomes:
measure: Primary Endpoint
timeFrame: 3 months
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: 3 Months
Other outcomes:
measure: Performance
timeFrame: Immediate
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp (UZA)
city: Berlin
country: Germany
facility: The Charité - Universitätsmedizin
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Muenster
country: Germany
facility: St Franziskus Hospital
city: Blackrock
country: Ireland
facility: Blackrock Clinic
city: Dublin
country: Ireland
facility: St James Hospital
city: London
country: United Kingdom
facility: St George's Hospital
Study officials:
affiliation: St Fraziskus Hospital, Muenster, Germany
name: Prof. Dr. med Giovanni Torsello, MD
role: PRINCIPAL_INVESTIGATOR
References: