Percutaneous Closure of Arteriotomy in Common Femoral Artery Clinical Trial
— FRONTIER-IOfficial title:
Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER I 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 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.
Status | Completed |
Enrollment | 12 |
Est. completion date | May 2015 |
Est. primary completion date | July 2014 |
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 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. Exclusion Criteria: There will be no exclusion of patients from this trial in respect of race, co-existent disease or concomitant therapy, with the exception of those listed below. - 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. - 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 an access site 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 prior to 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.* - May not be known until after the patient has given informed consent and the procedure has started. |
Country | Name | City | State |
---|---|---|---|
Ireland | St Jame's Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
Vivasure Medical Limited |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Performance | Assessed by technical success rate for the VIVASURE CLOSURE DEVICE™ (Tech Success: haemostasis by investigational device, not leading to alternative treatment other than manual compression or adjunctive endovascular ballooning) | up to 3 month of implantation | |
Primary | 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 | Minor Vascular Complications Directly Related to Device | Incidence of minor complications directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, as defined by VARC-2. | up to 3 months from implantation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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N/A |