Status:
COMPLETED
Safety and Performance Study of Large Hole Vascular Closure Device FIV
Lead Sponsor:
Vivasure Medical Limited
Conditions:
Percutaneous CFA Arteriotomy Closure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this Clinical Investigation Plan (CIP) is to: 1. Confirm the safety and performance of the PerQseal® large hole closure system. 2. To expand its indications of use to include common fe...
Detailed Description
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® in 75 patients in approximately 10 European investigational sites. The...
Eligibility Criteria
Inclusion
- Over 18 years of age.
- Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
- Clinically indicated for an endovascular procedure using a common femoral arteriotomy created by a 12 - 20 F sheath.
Exclusion
- Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than six months.
- Evidence of systemic bacterial or cutaneous infection, including groin infection.
- Known bleeding diathesis, definite or potential coagulopathy, platelet count \< 100,000/μl or patients on long term anticoagulants with an INR greater than 1.2 at time of procedure or known type II heparin-induced thrombocytopenia.
- Severe; claudication or peripheral vascular disease (e.g. Rutherford category 3 or greater or ABI \< 0.5), documented untreated iliac artery diameter stenosis \> 50% or previous bypass surgery/stent placement in the common femoral artery of ipsilateral limb.
- Known allergy to any of the materials used in the PerQseal®.
- Subject has undergone a percutaneous procedure using a non-absorbable vascular closure device (excluding suture mediated) for haemostasis in the ipsilateral target leg.
- Patients that have undergone a percutaneous procedure in the ipsilateral leg, within the previous 30 days.
- Patients that have undergone a percutaneous procedure using an absorbable intravascular closure device for haemostasis, in the ipsilateral leg, within the previous 90 days.
- Evidence of arterial diameter stenosis \> 20% or anterior or circumferential calcification within 20 mm proximal or distal to target arteriotomy site based on pre-procedure CT angiography.
- Females who are pregnant or lactating or in fertile period not taking adequate contraceptives. A pregnancy test may be performed.
- Patients that have a lower extremity amputation from the ipsilateral or contralateral limb.
- Arterial access other than common femoral artery obtained for ipsilateral target leg.
- Subject has a tissue tract expected to be greater than 10 cm.
- Use of thrombolytic agents within 24 hours prior to or during the endovascular procedure which causes fibrinogen \< 100 mg/dl.
- Significant blood loss/transfusion (defined as requiring transfusion of 4 or more units of blood products) during index procedure or within 30 days prior to index procedure.
- Activated clotting time (ACT) \> 350 seconds immediately prior to sheath removal or if ACT measurements are expected to be \> 350 seconds for more than 24 hours after index procedure.
- Target puncture site is located in a vascular graft.
- Target arteriotomy in the profunda femoris or superficial femoral artery or is in common femoral artery, but within 10 mm proximal of the bifurcation of the Superficial Femoral /Profunda Femoris artery.
- PerQseal® Introducer-sheath to ipsilateral femoral artery diameter ratio is greater than or equal to 1.05.
- Subjects with an acute haematoma of any size, arteriovenous fistula or pseudoaneurysm at the target access site; or angiographic evidence of arterial laceration or dissection within the external iliac or femoral artery before the use of the PerQseal® closure device.
Key Trial Info
Start Date :
October 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2019
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03423602
Start Date
October 12 2017
End Date
November 19 2019
Last Update
February 1 2023
Active Locations (11)
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1
Kerckhoff Klinik, Bad Nauheim
Bad Nauheim, Hesse, Germany, 61231
2
CardioVasculäres Centrum
Frankfurt am Main, Hesse, Germany, 60389
3
Uniklinik Köln, Herzzentrum
Cologne, North Rhine-Westphalia, Germany, 50937
4
Contilia Heart and Vascular centre
Essen, North Rhine-Westphalia, Germany, 45138