Percutaneous Common Femoral Artery Arteriotomy Closure Clinical Trial
— FRONTIER-IIOfficial title:
Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER II Study
| Verified date | January 2018 |
| Source | Vivasure Medical Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 65 |
| Est. completion date | November 2017 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Antwerp (UZA) | Edegem | |
| Germany | The Charité - Universitätsmedizin | Berlin | |
| Germany | Vivantes Klinikum im Friedrichshain | Berlin | |
| Germany | University Hospital Bonn | Bonn | |
| Germany | University Hospital Leipzig | Leipzig | |
| Germany | St Franziskus Hospital | Muenster | |
| Ireland | Blackrock Clinic | Blackrock | |
| Ireland | St James Hospital | Dublin | |
| United Kingdom | St George's Hospital | London |
| Lead Sponsor | Collaborator |
|---|---|
| Vivasure Medical Limited |
Belgium, Germany, Ireland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Performance | Technical success rate for the VIVASURE CLOSURE DEVICE™ | Immediate | |
| Primary | Primary Endpoint | Incidence and severity of major complication rates (as defined by VARC-2) 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 | 3 months | |
| Secondary | Secondary Endpoint | Incidence of minor complications (as defined by VARC-2) directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation. | 3 Months |