18 to 24 F Percutaneous Femoral Arteriotomy ClosureFrontier-IIINCT02788448
Safety and Performance Study of Large Hole Vascular Closure Device
A study testing VIVASURE CLOSURE DEVICE in people with 18 to 24 F Percutaneous Femoral Arteriotomy Closure, run by Vivasure Medical Limited at 3 sites in Germany.
Trial summary
The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, 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
- 18 to 24 F Percutaneous Femoral Arteriotomy Closure
- 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
- 42 participants
- Where
- 3 sitesGermany
- Study dates
- Jan 2016to Nov 2017
- 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.
- 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
- 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) 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.
- Patient with a haematocrit of less than 30 %.
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- 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 DP2 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 the ipsilateral or contralateral 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 DP2 Device.*
- Severe claudication, stenosis of the iliac artery > 50% or previous bypass surgery/stent placement in the region of the vascular access.
- May not be known until after the patient has given informed consent and the procedure has started. In this event, the DP2 Device should not be used and the patient should be considered excluded from the study and intention to treat analysis.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
The Charité - Universitätsmedizin
Berlin, 10117
University Hospital Leipzig
Leipzig, 04109
St Franziskus Hospital
Münster
About this study
Official title: Clinical Investigation Plan (CIP) for Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER III Study
The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures.
This is a non-inferiority study based on safety. Safety will be assessed by incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE up to 3 months from implantation is no worse than those associated with cut-down and sutured close.
Read the detailed description
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the VIVASURE CLOSURE DEVICE. The study shall not be blinded prior to, during or post the procedure. 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.
All subjects shall have an immediately post procedure, 24 hour, 1, 3 and 12 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee.
- Being tested
- VIVASURE CLOSURE DEVICE
- Keywords
- Percutaneous vascular closure device, Large hole closure device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVASURE CLOSURE DEVICEDevice
Also called DP2-FA1-2
Large hole closure device
| Study group | Role | What they receive |
|---|---|---|
| VIVASURE CLOSURE DEVICE | Experimental | Large hole 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 [Safety]
Incidence of major vascular complications directly related to study Device (as defined by VARC-2)
Measured: up to 3 Months
Secondary outcomes (2)
Minor vascular complications [Safety]
Incidence of minor vascular complications directly related to the study Device (as defined by VARC-2)
Measured: up to 3 Months
Study device technical success rate [Performance]
Technical success rate for the study Device (percentage of subjects 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.
- First posted2 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 18 to 24 F Percutaneous Femoral 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
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivasure Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. med Giovanni Torsello, MD, Principal investigator, St Fraziskus Hospital, Muenster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788448
- Sponsor's protocol ID
- P384-00
- Acronym
- Frontier-III
- Status last verified
- Jan 2018
- First submitted
- 25 May 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. 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 III Study
- ClinicalTrials.gov ID
- NCT02788448
- Acronym / sponsor ID
- Frontier-III / P384-00
- Keywords
- Percutaneous vascular closure device, Large hole closure device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Vivasure Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 2 Jun 2016 (estimated)
- 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.
The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures.
This is a non-inferiority study based on safety. Safety will be assessed by incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE up to 3 months from implantation is no worse than those associated with cut-down and sutured close.
Detailed description
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the VIVASURE CLOSURE DEVICE. The study shall not be blinded prior to, during or post the procedure. 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.
All subjects shall have an immediately post procedure, 24 hour, 1, 3 and 12 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIVASURE CLOSURE DEVICE | Experimental | Device: VIVASURE CLOSURE DEVICELarge hole 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)
- 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) 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.
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 DEVICEAlso: DP2-FA1-2Large hole closure device | Device | VIVASURE CLOSURE DEVICE |
Primary outcome
Major vascular complications [Safety]
Time frame: up to 3 Months
Incidence of major vascular complications directly related to study Device (as defined by VARC-2)
2 secondary outcomes
Minor vascular complications [Safety]
Time frame: up to 3 Months
Study device technical success rate [Performance]
Time frame: within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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.
Prof. Dr. med Giovanni Torsello, MD principal investigator
St Fraziskus Hospital, Muenster, Germany
3 sites 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 18 to 24 F Percutaneous Femoral Arteriotomy Closure, run by Vivasure Medical Limited at 3 sites in Germany.
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 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 3 Months). 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 1 Feb 2018.