Status:
COMPLETED
Safety and Performance Study of Large Hole Vascular Closure Device
Lead Sponsor:
Vivasure Medical Limited
Conditions:
Percutaneous Common Femoral Artery Arteriotomy Closure
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02241642
Start Date
October 1 2013
End Date
November 1 2017
Last Update
February 1 2018
Active Locations (9)
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1
University Hospital Antwerp (UZA)
Edegem, Belgium
2
The Charité - Universitätsmedizin
Berlin, Germany, 10117
3
Vivantes Klinikum im Friedrichshain
Berlin, Germany
4
University Hospital Bonn
Bonn, Germany