Safety and Performance Study of Large Hole Vascular Closure Device FIV

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03423602
• Date of registration: 31/01/2018
• Prospective Registration: No
• Primary sponsor: Vivasure Medical Limited
• Public title: Safety and Performance Study of Large Hole Vascular Closure Device FIV Frontier-IV
• Scientific title: Clinical Investigation Plan (CIP) for Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER IV Study
• Date of first enrolment: October 12, 2017
• Target sample size: 75
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03423602
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Germany, Ireland

Contacts

• Name: Dr Chris Martin

• Name: Dr Arne Schwindt
• Affiliation: St Fraziskus Hospital, Muenster, Germany

• Name: Dr Christoph Naber
• Affiliation: Contilia Heart and Vascular centre, Essen, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

I. Over 18 years of age. ii. Subject is willing and able to provide appropriate
study-specific informed consent, follow protocol procedures, and comply with follow-up
visit requirements.

iii. Clinically indicated for an endovascular procedure using a common femoral arteriotomy
created by a 12 - 20 F sheath.

Exclusion Criteria:

i. Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of
less than six months.

ii. Evidence of systemic bacterial or cutaneous infection, including groin infection.

iii. 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.

iv. 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.

v. Known allergy to any of the materials used in the PerQseal®. vi. Subject has undergone a
percutaneous procedure using a non-absorbable vascular closure device (excluding suture
mediated) for haemostasis in the ipsilateral target leg.

vii. Patients that have undergone a percutaneous procedure in the ipsilateral leg, within
the previous 30 days.

viii. Patients that have undergone a percutaneous procedure using an absorbable
intravascular closure device for haemostasis, in the ipsilateral leg, within the previous
90 days.

ix. 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.

x. Females who are pregnant or lactating or in fertile period not taking adequate
contraceptives. A pregnancy test may be performed.

xi. Patients that have a lower extremity amputation from the ipsilateral or contralateral
limb.

xii. Arterial access other than common femoral artery obtained for ipsilateral target leg.

xiii. Subject has a tissue tract expected to be greater than 10 cm. xiv. Use of
thrombolytic agents within 24 hours prior to or during the endovascular procedure which
causes fibrinogen < 100 mg/dl.

xv. 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.

xvi. 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.

xvii. Target puncture site is located in a vascular graft. xviii. 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.

xix. PerQseal® Introducer-sheath to ipsilateral femoral artery diameter ratio is greater
than or equal to 1.05.

xx. 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Percutaneous CFA Arteriotomy Closure

Intervention(s)

Device: PerQseal®

Primary Outcome(s)

Major vascular complications [Safety] [Time Frame: up to 1 month post implantation]

Secondary Outcome(s)

Minor vascular complications [Safety] [Time Frame: up to 1 month from implantation]

Study device technical success rate [Performance] [Time Frame: within 24 hours]

Secondary ID(s)

P528-00

Source(s) of Monetary Support

Please refer to primary and secondary sponsors