Percutaneous Closure of Arteriotomy in Common Femoral ArteryFRONTIER-INCT01943344
Safety and Performance Study of Large Hole Vascular Closure Device
A study testing VIVASURE CLOSURE DEVICE™ in people with Percutaneous Closure of Arteriotomy in Common Femoral Artery, run by Vivasure Medical Limited at 1 site in Ireland.
Trial summary
The purpose of this Clinical Investigation is to gather feasibility data on the clinical use of the VIVASURE CLOSURE DEVICE™ in relation to safety, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Closure of Arteriotomy in Common Femoral Artery
- What is being tested?
- VIVASURE CLOSURE DEVICE™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIreland
- Study dates
- Jul 2013to May 2015
- 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.
- Each patient, or his or her guardian or legal representative, is willing to give informed consent.
- Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 - 24 F.
- Females who are not pregnant or lactating, and not planning to become pregnant ≤ 12 months. A pregnancy test may be performed to confirm this.
Who cannot join
- There will be no exclusion of patients from this trial in respect of race, co-existent disease or concomitant therapy, with the exception of those listed below.
- Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year.
- Evidence of systemic bacterial or cutaneous infection, including groin infection.
- Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) and/or VRE (vancomycin-resistant Enterococci) colonisation.
- With arterial access other than the common femoral artery.*
- Patients suffering with definitive or potential coagulopathy or platelet count less than 100,000/µl.
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- Patient with a haematocrit of less than 32 %.
- A measured activated clotting time (ACT) of greater than 350 seconds immediately prior to sheath removal.*
- If patients are expected to be continuously treated with anticoagulation therapy post-procedure such that their ACT reading is expected to be elevated above 350 seconds for more than 24 hours after the procedure.
- Evidence of arterial diameter stenosis greater than 20 % within 20 mm of the arteriotomy.*
- Circumferential calcification within 20 mm of the arteriotomy.*
- Use of systemic thrombolytic agents within 24 hours prior to or during the catheterisation procedure which cause the concentration of fibrinogen to be less than 100 mg/dl.
- Patients in which the arteriotomy is less than 18 F or greater than 24 F.*
- Known allergy to any of the materials used in the device (Refer to Instructions for Use).
- Currently enrolled in any other investigational clinical study, where the primary endpoint has not yet been achieved.
- Patients judged unsuitable for surgical repair of the access site.
- If puncture site is via a vascular graft.
- If there is any indication that the puncture has been made in the profunda femoris or located less than 10 mm above the profunda femoris.*
- Patients with a common femoral artery lumen diameter of less than 7 mm.
- Patients that have a lower extremity amputation from an access site limb.
- Patients that have undergone a percutaneous procedure using a non-absorbable vascular closure device (excluding suture mediated) for haemostasis in the ipsilateral leg.
- Patients that have undergone a percutaneous procedure greater than 8 F in the ipsilateral leg, within the previous 90 days.
- Patients that have undergone a percutaneous procedure of 8 F or less using an absorbable intravascular closure device for haemostasis, in the ipsilateral leg, within the previous 90 days.
- Patients that have undergone a percutaneous procedure of 8 F or less using a suture mediated closure device for haemostasis, in the ipsilateral leg, within the previous 30 days.
- Patients that have undergone a percutaneous procedure of 8 F or less using manual/mechanical pressure for haemostasis in the ipsilateral leg, within the previous 30 days.
- Patients with an acute haematoma of any size, arteriovenous fistula or Pseudoaneurysm at the access site.*
- Significant blood loss/transfusion during interventional procedure or within 20 days prior to procedure requiring transfusion of greater than 4 units of blood.*
- Angiographic evidence of arterial laceration, dissection or stenosis within the external iliac or femoral artery before the use of the VCD.*
- May not be known until after the patient has given informed consent and the procedure has started.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER I Study
The purpose of this Clinical Investigation is to gather feasibility data on the clinical use of the VIVASURE CLOSURE DEVICE™ in relation to safety, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures.
Read the detailed description
This study will be a prospective, multi-centred, non-randomized pilot study to investigate the safety and performance of the VIVASURE CLOSURE DEVICE™. All patients undergoing a procedure requiring an arteriotomy in the range of 18 to 24 F, 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.
Patient safety will be monitored closely by the Data Safety Monitoring Committee (DSMC). Safety data will be reported to the DSMC for every patient with a reported complication. The DSMC will adjudicate on the safety data to determine whether it is safe to continue enrolment.
Subjects shall have a 1, 3 and 12 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee.
This protocol will adopt the VARC-2 definitions for major vascular complication associated with closure of the access site.
This pilot study will enrol approximately 10 subjects. The study is designed to support a larger CE Mark study. As such, a study safety assessment will be complete when all patients have completed their 1 month follow-up assessment. The Data Safety Monitoring Committee (DSMC) will review all complications and recommend whether it is safe to proceed to the CE Mark study. All patients will continue to be followed at 1, 3 and 12 month follow-ups.
- Being tested
- VIVASURE CLOSURE DEVICE™
- Keywords
- vascular large hole closure, arteriotomy closure, Large hole vascular closure device, vascular closure device, percutaneous vascular closure device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVASURE CLOSURE DEVICE™Device
Also called DP2, DP2-FA1-1
implantation of VIVASURE CLOSURE DEVICE™
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects that receive VIVASURE CLOSURE DEVICE™ Receives: Device: VIVASURE CLOSURE DEVICE™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Vascular Complications Directly Related to Device
Major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, (as defined by VARC-2).
Measured: up to 3 Months of implantation
Secondary outcomes (1)
Minor Vascular Complications Directly Related to Device
Incidence of minor complications directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, as defined by VARC-2.
Measured: up to 3 months from implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014
- Study completionMay 2015
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 Closure of Arteriotomy in Common Femoral ArteryStudies 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
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivasure Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Peter Crean, FRCPI MB ChB, Principal investigator, St Jame's Hospital, Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943344
- Sponsor's protocol ID
- P043-00
- Other IDs
- EUDAMED: CIV-IE-13-01-009581
- Acronym
- FRONTIER-I
- Status last verified
- Jan 2018
- First submitted
- 11 Sep 2013
- Last updated
- 2 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER I Study
- ClinicalTrials.gov ID
- NCT01943344
- Acronym / sponsor ID
- FRONTIER-I / P043-00
- Keywords
- vascular large hole closure, arteriotomy closure, Large hole vascular closure device, vascular closure device, percutaneous vascular closure device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vivasure Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Posted 6 Jul 2016
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 is to gather feasibility data on the clinical use of the VIVASURE CLOSURE DEVICE™ in relation to safety, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures.
Detailed description
This study will be a prospective, multi-centred, non-randomized pilot study to investigate the safety and performance of the VIVASURE CLOSURE DEVICE™. All patients undergoing a procedure requiring an arteriotomy in the range of 18 to 24 F, 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.
Patient safety will be monitored closely by the Data Safety Monitoring Committee (DSMC). Safety data will be reported to the DSMC for every patient with a reported complication. The DSMC will adjudicate on the safety data to determine whether it is safe to continue enrolment.
Subjects shall have a 1, 3 and 12 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee.
This protocol will adopt the VARC-2 definitions for major vascular complication associated with closure of the access site.
This pilot study will enrol approximately 10 subjects. The study is designed to support a larger CE Mark study. As such, a study safety assessment will be complete when all patients have completed their 1 month follow-up assessment. The Data Safety Monitoring Committee (DSMC) will review all complications and recommend whether it is safe to proceed to the CE Mark study. All patients will continue to be followed at 1, 3 and 12 month follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: VIVASURE CLOSURE DEVICE™Subjects that receive VIVASURE CLOSURE DEVICE™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years of age.
- Each patient, or his or her guardian or legal representative, is willing to give informed consent.
- Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 - 24 F.
- Females who are not pregnant or lactating, and not planning to become pregnant ≤ 12 months. A pregnancy test may be performed to confirm this.
Key exclusion criteria (29 listed)
- There will be no exclusion of patients from this trial in respect of race, co-existent disease or concomitant therapy, with the exception of those listed below.
- Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year.
- Evidence of systemic bacterial or cutaneous infection, including groin infection.
- Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) and/or VRE (vancomycin-resistant Enterococci) colonisation.
- With arterial access other than the common femoral artery.*
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 |
|---|---|---|
| VIVASURE CLOSURE DEVICE™Also: DP2, DP2-FA1-1implantation of VIVASURE CLOSURE DEVICE™ | Device | Treatment |
Primary outcome
Major Vascular Complications Directly Related to Device
Time frame: up to 3 Months of implantation
Major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, (as defined by VARC-2).
1 secondary outcome
Minor Vascular Complications Directly Related to Device
Time frame: up to 3 months from implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Peter Crean, FRCPI MB ChB principal investigator
St Jame's Hospital, Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIVASURE CLOSURE DEVICE™ in people with Percutaneous Closure of Arteriotomy in Common Femoral Artery, run by Vivasure Medical Limited at 1 site in Ireland.
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 4 inclusion and 29 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 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 6 Jul 2016). 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 Directly Related to Device (time frame: up to 3 Months of implantation). 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 2 Nov 2018.