Safety and Performance Study of Large Hole Vascular Closure Device
- Conditions
- Percutaneous Common Femoral Artery Arteriotomy Closure
- Interventions
- Device: VIVASURE CLOSURE DEVICE™
- Registration Number
- NCT02241642
- Lead Sponsor
- Vivasure Medical Limited
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment VIVASURE CLOSURE DEVICE™ VIVASURE CLOSURE DEVICE™
- Primary Outcome Measures
Name Time Method Primary Endpoint 3 months 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
- Secondary Outcome Measures
Name Time Method Secondary Endpoint 3 Months Incidence of minor complications (as defined by VARC-2) directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation.
Trial Locations
- Locations (9)
University Hospital Antwerp (UZA)
🇧🇪Edegem, Belgium
St James Hospital
🇮🇪Dublin, Ireland
Blackrock Clinic
🇮🇪Blackrock, Ireland
The Charité - Universitätsmedizin
🇩🇪Berlin, Germany
Vivantes Klinikum im Friedrichshain
🇩🇪Berlin, Germany
University Hospital Leipzig
🇩🇪Leipzig, Germany
St Franziskus Hospital
🇩🇪Muenster, Germany
University Hospital Bonn
🇩🇪Bonn, Germany
St George's Hospital
🇬🇧London, United Kingdom