Percutaneous CFA Arteriotomy ClosureFrontier-IVNCT03423602

Safety and Performance Study of Large Hole Vascular Closure Device FIV

A study testing PerQseal® in people with Percutaneous CFA Arteriotomy Closure, run by Vivasure Medical Limited at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Percutaneous CFA Arteriotomy Closure
What is being tested?: PerQseal®
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 11 sitesin 2 countries
Study dates: 12 Oct 2017to 19 Nov 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 20Show fewer

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.

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

Germany9 sites

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

Other trials in Germany

Ireland2 sites

Blackrock Clinic
Blackrock, Dublin
St James Hospital
Dublin

Other trials in Ireland

About this study

Official title: 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:

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

Read the 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.

Conditions: Percutaneous CFA Arteriotomy Closure
Being tested: PerQseal®
Keywords: Percutaneous vascular closure device, Large hole closure device, Arteriotomy closure, Vascular closure device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PerQseal®Device
Also called DP2-FA1-4 DP2-FA1-5 DP2-FA1-6
Large hole closure system

Study groups in NCT03423602
Study group	Role	What they receive
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. Receives: Device: PerQseal®

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Minor Vascular Complications [Safety]
Rate of minor vascular access site complications directly related to the PerQseal® closure device (as defined by VARC-2)
Measured: 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
Measured: within 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 201719 Nov 2019

First posted6 Feb 2018
Study start12 Oct 2017
Primary completion19 Nov 2019
Study completion19 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Percutaneous CFA Arteriotomy ClosureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: prospective, multi-centred, non-randomized study
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03423602
Sponsor's protocol ID: P528-00
Acronym: Frontier-IV
Status last verified: Jan 2023
First submitted: 31 Jan 2018
Last updated: 1 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation Plan (CIP) for Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER IV Study
ClinicalTrials.gov ID: NCT03423602
Acronym / sponsor ID: Frontier-IV / P528-00
Conditions: Percutaneous CFA Arteriotomy Closure
Keywords: Percutaneous vascular closure device, Large hole closure device, Arteriotomy closure, Vascular closure device
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Vivasure Medical LimitedIndustry (pharma, biotech, devices)
Study start: 12 Oct 2017 (actual)
Primary completion: 19 Nov 2019 (actual)
Study completion: 19 Nov 2019 (actual)
First posted: 6 Feb 2018 (actual)
Results: Posted 1 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: prospective, multi-centred, non-randomized study

Arm	Type	Receives
Investigational device	Experimental	Device: PerQseal®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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (20 listed)

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®.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PerQseal®Also: DP2-FA1-4 DP2-FA1-5 DP2-FA1-6Large hole closure system	Device	Investigational device

Primary outcome

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

2 secondary outcomes

Minor Vascular Complications [Safety]
Time frame: up to 1 month from implantation
Study Device Technical Success Rate [Performance]
Time frame: within 24 hours

Results and safety

Results posted to the registry on 1 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational Device	75	63

Primary outcome: Major Vascular Complications [Safety]

Time frame: up to 1 month post implantation. Count of participants. Unit: Participants

Measure	Investigational Device n = 75
Value	0

Investigational Device: Wilson's exact test: 0.0487, p <.0001, Wilson's exact test

Population analysed: All enrolled subjects with any major device related event. Includes all subjects through the last assessment prior to or at 1-month post implantation.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Subject enrolment to study exit which was 3-months ± 1-month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational Device	21 of 75 (28%)	5 of 75 (6.7%)	1 of 75

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr Arne Schwindt principal investigator

St Fraziskus Hospital, Muenster, Germany

Dr Christoph Naber principal investigator

Contilia Heart and Vascular centre, Essen, Germany

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PerQseal® in people with Percutaneous CFA Arteriotomy Closure, run by Vivasure Medical Limited at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Vascular Complications [Safety] (time frame: up to 1 month post implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03423602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.