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

Clinical Investigation Plan (CIP) for Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER IV Study

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.

Study Overview

• Status: Completed
• Conditions: Percutaneous CFA Arteriotomy Closure
• Intervention / Treatment: Device: PerQseal®

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg Medizinische Abteilung
  • Berlin
    • Berlin-Mitte, Berlin, Germany, 10117
      • The Charité - Universitätsmedizin
  • Hesse
    • Bad Nauheim, Hesse, Germany, 61231
      • Kerckhoff Klinik, Bad Nauheim
    • Frankfurt am Main, Hesse, Germany, 60389
      • CardioVasculäres Centrum
  • North Rhine-Westphalia
    • Essen, North Rhine-Westphalia, Germany, 45138
      • Contilia Heart and Vascular centre
    • Köln, North Rhine-Westphalia, Germany, 50937
      • Uniklinik Köln, Herzzentrum
    • Muenster, North Rhine-Westphalia, Germany
      • St Franziskus Hospital
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Universitätsmedizin Mainz
  • Saxony
    • Leipzig, Saxony, Germany, 04109
      • Medical Faculty of the University of Leipzig
• Ireland
  • Dublin, Ireland
    • St James Hospital
  • Dublin
    • Blackrock, Dublin, Ireland
      • Blackrock Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Investigational device; To confirm safety and performance of the PerQseal® Closure Device (DP2-FA1-4) and PerQseal® Introducers (DP2-FA1-5 and DP2-FA1-6) to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 12 to 20 F sheaths.	Device: PerQseal®; Large hole closure system; Other Names: DP2-FA1-4 DP2-FA1-5 DP2-FA1-6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Vascular Complications [Safety]	Rate of major vascular access site complications related to the PerQseal® closure device (as defined by VARC-2)	up to 1 month post implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minor Vascular Complications [Safety]	Rate of minor vascular access site complications directly related to the PerQseal® closure device (as defined by VARC-2)	up to 1 month from implantation
Study Device Technical Success Rate [Performance]	Percentage of closures (Limbs) with Technical Success, for the PerQseal® closure device, not requiring alternative therapy to achieve haemostasis	within 24 hours

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 12, 2017
• Primary Completion (ACTUAL): November 19, 2019
• Study Completion (ACTUAL): November 19, 2019

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (ACTUAL): February 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Vascular closure device; Percutaneous vascular closure device; Large hole closure device; Arteriotomy closure
• Other Study ID Numbers: P528-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No