Safety and Performance Study of Large Hole Vascular Closure Device FIV

NCT03423602 | Completed Results DMC

• 1 other identifier: P528-00
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 11

Brief Summary

The purpose of this Clinical Investigation Plan (CIP) is to:

1. 1.Confirm the safety and performance of the PerQseal® large hole closure system.
2. 2.To expand its indications of use to include common femoral arteriotomies created with 12 to 20 F sheaths in patients undergoing endovascular procedures.

Conditions

Percutaneous CFA Arteriotomy Closure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Minor Vascular Complications [Safety]

  up to 1 month from implantation

• Study Device Technical Success Rate [Performance]

  within 24 hours

Study Arms (1)

Investigational device

EXPERIMENTAL

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®

Interventions

PerQseal® DEVICE

Large hole closure system

Also known as: DP2-FA1-4 DP2-FA1-5 DP2-FA1-6

Investigational device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vivasure Medical Limited: lead

Study Sites (11)

Kerckhoff Klinik, Bad Nauheim

Bad Nauheim, Hesse, 61231, Germany

Location

CardioVasculäres Centrum

Frankfurt am Main, Hesse, 60389, Germany

Location

Uniklinik Köln, Herzzentrum

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Contilia Heart and Vascular centre

Essen, North Rhine-Westphalia, 45138, Germany

Location

St Franziskus Hospital

Münster, North Rhine-Westphalia, Germany

Location

Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Medical Faculty of the University of Leipzig

Leipzig, Saxony, 04109, Germany

Location

The Charité - Universitätsmedizin

Mitte, State of Berlin, 10117, Germany

Location

Asklepios Klinik St. Georg Medizinische Abteilung

Hamburg, 20099, Germany

Location

Blackrock Clinic

Blackrock, Dublin, Ireland

Location

St James Hospital

Dublin, Ireland

Location

Limitations and Caveats

Study was a single-arm study precluding any direct comparison with other VCDs. Patient population was selected based on inclusion/exclusion including a restriction of the Sheath to Femoral Artery Ratio greater than 1.05 and anterior or circumferential calcification at or near the access site. There are a relatively small number of subjects with a BMI greater than 30 in the study population. There was a relatively small number of subjects in the study with a primary sheath size greater than 19 F.

Results Point of Contact

• Title: Dr Chris Martin
• Organization: Vivasure Medical Ltd

chris.martin@vsuremed.com

+353 91 395 442

Study Officials

• Dr Arne Schwindt

  St Fraziskus Hospital, Muenster, Germany

  PRINCIPAL INVESTIGATOR

• Dr Christoph Naber

  Contilia Heart and Vascular centre, Essen, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, multi-centred, non-randomized study

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 6, 2018
• Study Start: October 12, 2017
• Primary Completion: November 19, 2019
• Study Completion: November 19, 2019
• Last Updated: February 1, 2023
• Results First Posted: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (9); IE (2)