Percutaneous Arteriotomy ClosureNCT04799769
Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER V Study
A study testing Percutaneous arterial closure device in people with Percutaneous Arteriotomy Closure, run by Vivasure Medical Limited at 5 sites in 2 countries.
Trial summary
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 90 patients in up to 8 European investigational sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Arteriotomy Closure
- What is being tested?
- Percutaneous arterial closure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 10 Mar 2021to 10 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 - 22 F sheath.
- General Exclusion Criteria:
- Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than four months.
- Evidence of systemic bacterial or cutaneous infection, including groin infection.
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- Known bleeding diathesis (including sever liver disease), definite or potential coagulopathy, platelet count < 100,000/µl or patients on long term anticoagulants with an INR greater than 2 at time of procedure or known type II heparin-induced thrombocytopenia.
- Previous groin surgery within the region of the ipsilateral access.
- 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® + or PerQseal® Introducer (refer to Investigator's Brochure for materials list).
- 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.
- Target puncture site is located in a vascular graft.
- Procedural Exclusion Criteria:
- Arterial access other than common femoral artery obtained for ipsilateral target leg.
- Subject has a tissue tract expected to be greater than 10 cm.
- 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.
- Unstable blood pressure or heart rate, symptoms of shock or systolic blood pressure greater than 160 mmHg (maybe controlled by pacing or pharmacologically eg. vasodilator such as nitrates etc.).
- 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 arteriotomy is in the profunda femoris or superficial femoral artery or is in common femoral artery, but within 15 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. (vessel lumen diameter of less than 7 mm.)
- Subjects with an acute haematoma of any size, arteriovenous fistula or pseudoaneurysm at the target access site; or any evidence of arterial laceration or dissection within the external iliac or femoral artery before the use of the PerQseal® + Closure Device.
- Use of thrombolytic agents within 24 hours prior to or during the endovascular procedure which causes fibrinogen < 100 mg/dl.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites, 4 recruiting
- Recruiting
Leipzig University Hospital
Leipzig, Saxony, 04103
Ursula Banning-Eichenseer, Ursula.Banning-Eichenseer@medizin.uni-leipzig.de
Janin Lenzer, Janin.Lenzer@medizin.uni-leipzig.de
- Recruiting
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, I323538
Christian Frerker, MD, Christian.Frerker@uksh.de
Tobias Schmidt, MD, Tobias.Schmidt2@uksh.de
- Recruiting
St. Franziskus-Hospital
Münster, Westphalia, 48 145
Sarah Damerau, +49 (0)251 / 935 5695, Sarah.Damerau@SFH-MUENSTER.de
Arne Schwindt, MD
- Recruiting
SHG-Kliniken Völklingen
Völklingen, Saarland, D-66333
Fernando Gatto, MD, f.gatto@vk.shg-kliniken.de
Fernando Gatto, MD
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Hospital
Rotterdam, South Holland, 3015
Nicolas van Mieghem, MD, n.vanmieghem@erasmusmc.nl
Nicolas van Meighem, MD
About this study
Official title: Clinical Investigation Plan (CIP) for Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER V Study
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 90 patients in up to 8 European investigational sites. The PerQseal® + shall be indicated for the percutaneous closure of femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created with 14 - 22F sheaths (arteriotomy up to 26 F).
Read the detailed description
The study will be designed to be a phased study with an initial enrolment of 25 subjects in phase 1. An interim analysis may be performed after phase 1 and the remainder (up to 65 subjects) may be enrolled as part of phase 2.
The study shall not be blinded prior to, during or post the procedure. All patients undergoing an endovascular procedure requiring an arteriotomy created by 14 to 22 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'. The closure will be percutaneous. An optional adjunctive endovascular balloon may be used to control bleeding. All safety data from the study will be assessed by the Data Safety Monitoring Committee on a continuous basis.
The Purpose of the Study is to assess safety and performance of the PerQseal® + Closure Device when used with the L PerQseal® Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 14 to 22 F sheaths.
- Conditions
- Percutaneous Arteriotomy Closure
- Being tested
- Percutaneous arterial closure device
- Keywords
- Arterial Closure, percutaneous arterial closure, large hole arterial closure, large bore arterial closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous arterial closure deviceDevice
Large hole percutaneous arterial closure device
| Study group | Role | What they receive |
|---|---|---|
| Test Device | Experimental | Investigational Device Arm Receives: Device: Percutaneous arterial closure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety
Major vascular access site complication rate related to the PerQseal® + Closure Device
Measured: 1-month post implantation (inclusive)
Secondary outcomes (2)
Secondary Safety
Minor vascular access site complication rate related to the PerQseal® + Closure Device
Measured: 1-month post implantation (inclusive)
Performance
Technical success rate for the PerQseal® + Closure Device
Measured: Up to 5 days post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start10 Mar 2021
- Primary completion10 Jan 2023 (estimated)
- Study completion10 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous 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 to investigate the safety and performance of the PerQseal® +
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivasure Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799769
- Sponsor's protocol ID
- P802-00
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- 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 12 Apr 2022. 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 V Study
- ClinicalTrials.gov ID
- NCT04799769
- Acronym / sponsor ID
- P802-00
- Conditions
- Percutaneous Arteriotomy Closure
- Keywords
- Arterial Closure, percutaneous arterial closure, large hole arterial closure, large bore arterial closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Vivasure Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 10 Jan 2023 (estimated)
- Study completion
- 10 Mar 2023 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 90 patients in up to 8 European investigational sites. The PerQseal® + shall be indicated for the percutaneous closure of femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created with 14 - 22F sheaths (arteriotomy up to 26 F).
Detailed description
The study will be designed to be a phased study with an initial enrolment of 25 subjects in phase 1. An interim analysis may be performed after phase 1 and the remainder (up to 65 subjects) may be enrolled as part of phase 2.
The study shall not be blinded prior to, during or post the procedure. All patients undergoing an endovascular procedure requiring an arteriotomy created by 14 to 22 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'. The closure will be percutaneous. An optional adjunctive endovascular balloon may be used to control bleeding. All safety data from the study will be assessed by the Data Safety Monitoring Committee on a continuous basis.
The Purpose of the Study is to assess safety and performance of the PerQseal® + Closure Device when used with the L PerQseal® Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 14 to 22 F sheaths.
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 to investigate the safety and performance of the PerQseal® +
| Arm | Type | Receives |
|---|---|---|
| Test Device | Experimental | Device: Percutaneous arterial closure deviceInvestigational Device Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 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 14 - 22 F sheath.
- Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than four months.
- Evidence of systemic bacterial or cutaneous infection, including groin infection.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Percutaneous arterial closure deviceLarge hole percutaneous arterial closure device | Device | Test Device |
Primary outcome
Primary Safety
Time frame: 1-month post implantation (inclusive)
Major vascular access site complication rate related to the PerQseal® + Closure Device
2 secondary outcomes
Secondary Safety
Time frame: 1-month post implantation (inclusive)
Performance
Time frame: Up to 5 days post implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- 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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous arterial closure device in people with Percutaneous Arteriotomy Closure, run by Vivasure Medical Limited at 5 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 27 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chris Martin, Dr (+353 91 395 440, chris.martin@vsuremed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety (time frame: 1-month post implantation (inclusive)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2022.