Safety and Performance Study of Large Hole Vascular Closure Device FIV (Frontier-IV)

• ClinicalTrials.gov Identifier: NCT03423602
• Recruitment Status: Unknown
• First Posted: February 6, 2018
• Last Update Posted: February 6, 2018
• Sponsor: Vivasure Medical Limited
• Information provided by (Responsible Party): Vivasure Medical Limited

Study Description

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 femoral arteriotomies created with 12 to 20 F sheaths in patients undergoing endovascular procedures.

Condition or disease	Intervention/treatment	Phase
Percutaneous CFA Arteriotomy Closure	Device: PerQseal®	Not Applicable

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 study shall not be blinded prior to, during or post the procedure. All patients undergoing an endovascular procedure requiring an arteriotomy created by 12 to 20 F sheaths, 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 and 3 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee on a continuous basis.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: prospective, multi-centred, non-randomized study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Investigation Plan (CIP) for Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER IV Study
• Actual Study Start Date: October 12, 2017
• Estimated Primary Completion Date: June 2018
• Estimated Study Completion Date: September 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Investigational device; PerQseal® closure system	Device: PerQseal®; Large hole closure system; Other Name: DP2-FA1-4 DP2-FA1-5 DP2-FA1-6

Outcome Measures

Primary Outcome Measures :

1. Major vascular complications [Safety] [ Time Frame: up to 1 month post implantation ]
   Incidence of major vascular access site complications related to the PerQseal® closure device (as defined by VARC-2)

Secondary Outcome Measures :

1. Minor vascular complications [Safety] [ Time Frame: up to 1 month from implantation ]
   Incidence of minor vascular access site complications directly related to the PerQseal® closure device (as defined by VARC-2)
2. Study device technical success rate [Performance] [ Time Frame: within 24 hours ]
   Technical success rate for the PerQseal® closure device (percentage of subjects not requiring alternative therapy to achieve haemostasis)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Dr Chris Martin; +353 9 395 440; chris.martin@vsuremed.com

Locations

Germany

The Charité - Universitätsmedizin; Recruiting

Berlin-Mitte, Berlin, Germany, 10117

Principal Investigator: Dr Michael Laule, MD

Sub-Investigator: Dr Henryk Dreger, MD

Kerckhoff Klinik, Bad Nauheim; Recruiting

Bad Nauheim, Hesse, Germany, 61231

Principal Investigator: Dr Won-Keun Kim, MD

Sub-Investigator: Dr Christoph Liebetrau, MD

Sub-Investigator: Dr Matthias Renker, MD

CardioVasculäres Centrum; Recruiting

Frankfurt am Main, Hesse, Germany, 60389

Principal Investigator: Prof Horst Sievert, MD

Sub-Investigator: Dr Iiona Hofmann, MD

Sub-Investigator: Dr Kolja Sievert, MD

Sub-Investigator: Dr Laura Vaskelyte, MD

Sub-Investigator: Dr Markus Reinartz, MD

Sub-Investigator: Dr Predrag Matić, MD

Contilia Heart and Vascular centre; Recruiting

Essen, North Rhine-Westphalia, Germany, 45138

Principal Investigator: Dr Christoph Naber, MD

Sub-Investigator: Dr Alexander Wolf, MD

Sub-Investigator: Dr Thomas Schmitz, MD

Sub-Investigator: Dr Pieter Ghijselinck, MD

Sub-Investigator: Dr Esther Vogel, MD

Sub-Investigator: Dr Sultan Alotaibi, MD

Sub-Investigator: Dr Ingmar Seifert, MD

Sub-Investigator: Dr Christoph Jensen, MD

Sub-Investigator: Dr Regina Eder, MD

Sub-Investigator: Dr Ioannis Tsilingiris, MD

Uniklinik Köln, Herzzentrum; Recruiting

Köln, North Rhine-Westphalia, Germany, 50937

Principal Investigator: Prof Tanja Rudolph, MD

Sub-Investigator: Dr Kai Friedrichs, MD

Sub-Investigator: Dr Elma Kuhn, MD

Sub-Investigator: Prof Volker Rudolph, MD

Sub-Investigator: Dr Navid Mader, MD

Sub-Investigator: Prof Thorsten Wahlers, MD

St Franziskus Hospital; Not yet recruiting

Muenster, North Rhine-Westphalia, Germany

Principal Investigator: Dr Arne Schwindt, MD

Sub-Investigator: Dr Theodosios Bisdas, MD

Universitätsmedizin Mainz; Recruiting

Mainz, Rhineland-Palatinate, Germany, 55131

Principal Investigator: Dr Eberhard Schulz, MD

Sub-Investigator: Dr Ralph von Bardeleben, MD

Medical Faculty of the University of Leipzig; Recruiting

Leipzig, Saxony, Germany, 04109

Principal Investigator: Prof Dierk Scheinert, MD

Sub-Investigator: Dr Andrej Schmidt, MD

Sub-Investigator: Dr Daniela Branzan, MD

Sub-Investigator: Dr Holger Staab, MD

Asklepios Klinik St. Georg Medizinische Abteilung; Recruiting

Hamburg, Germany, 20099

Principal Investigator: Dr Christian Freker, MD

Sub-Investigator: Dr Tobias Schmidt, MD

Sub-Investigator: Dr Dimitry Schewel, MD

Sub-Investigator: Prof Karl-Heinz Kuck, MD

Ireland

Blackrock Clinic; Recruiting

Blackrock, Dublin, Ireland

Principal Investigator: Dr Peter Crean, MD

St James Hospital; Recruiting

Dublin, Ireland

Principal Investigator: Dr Peter Crean, MD

Sponsors and Collaborators

Vivasure Medical Limited

Investigators

• Principal Investigator: Dr Arne Schwindt; St Fraziskus Hospital, Muenster, Germany
• Principal Investigator: Dr Christoph Naber; Contilia Heart and Vascular centre, Essen, Germany

More Information

• Responsible Party: Vivasure Medical Limited
• ClinicalTrials.gov Identifier: NCT03423602
• Other Study ID Numbers: P528-00
• First Posted: February 6, 2018
• Last Update Posted: February 6, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vivasure Medical Limited:

Percutaneous vascular closure device; Large hole closure device; Arteriotomy closure; Vascular closure device