Safety and Performance Study of Large Hole Vascular Closure Device (FRONTIER-II)

Vivasure Medical

Status

Completed

Conditions

Percutaneous Common Femoral Artery Arteriotomy Closure

Treatments

Device: VIVASURE CLOSURE DEVICE™

Study type

Interventional

Funder types

Industry

Identifiers

NCT02241642

P190-00

CIV-13-11-011700 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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