Large Hole Percutaneous Arterial ClosureELITENCT05951634
Safety and Performance Study for Arterial Large Hole Vascular Closure Device
A study testing PerQseal ELITE in people with Large Hole Percutaneous Arterial Closure, run by Vivasure Medical Limited.
Trial summary
To study will assess safety and performance of the PerQseal Elite Closure Device when used with the 18F PerQseal Elite 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Large Hole Percutaneous Arterial Closure
- What is being tested?
- PerQseal ELITE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Sep 2025
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years.
- Clinically indicated for a percutaneous arterial interventional catheter-based procedure, e.g., transcatheter aortic valve replacement/implantation (TAVR/TAVI) or endovascular abdominal aortic aneurysm repair (EVAR), or thoracic endovascular aortic aneurysm repair (TEVAR), or use of a circulatory assist device or extracorporeal oxygenation using a common femoral arteriotomy created by a 14 to 22F sheath (arteriotomy up to 26F).
- Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
- Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.
Who cannot join
- Baseline Exclusion Criteria:
- Evidence of current systemic bacterial or cutaneous infection, including groin infection,
- Known bleeding diathesis, definite or potential coagulopathy, platelet count < 100,000/µl or subjects on long term anticoagulants with an INR > 2 within 12 hours prior to index procedure,
- Significant anaemia (example: haemoglobin < 9 g/dL or haematocrit < 27%), within 24 hours prior to index procedure,
- Known type II heparin-induced thrombocytopenia,
- Documented left ventricular ejection fraction < 20%,
Show all 42Show fewer
- Ipsilateral or contralateral lower extremity amputation,
- Previous groin surgery within the region of the ipsilateral access,
- Claudication (Rutherford category 3 or greater), documented untreated iliac or common femoral artery diameter stenosis > 50% or previous bypass surgery/stent placement in the common femoral artery of target leg,
- Known existing nerve damage in the target leg,
- Renal insufficiency (Glomerular Filtration Rate ≤ 30 ml/min or baseline serum creatinine > 2.5 mg/dl) or on renal replacement therapy,
- Known allergy to any of the materials used in the PerQseal Elite device (refer to Investigator's Brochure),
- Subject is unsuitable for surgical repair of the target leg access site,
- Subject has undergone a percutaneous procedure greater than 8F sheath in the target leg, within the 90-days prior to index procedure,
- Subject has undergone a percutaneous procedure of 8F sheath or less using an absorbable intravascular closure device for haemostasis, in the target leg, within the 90-days prior to index procedure,
- Subject has undergone a percutaneous procedure of 8F sheath or less using a suture mediated closure device or manual/mechanical pressure for haemostasis in the target leg, within the 30-days prior to index procedure,
- Evidence of marked tortuosity of the femoral or external iliac arteries in the target leg, based on pre-primary procedure CT angiography,
- Evidence of arterial diameter stenosis > 20% within 15 mm proximal or distal to arteriotomy site based on pre-primary procedure CT angiography,
- Evidence of anterior wall calcification of the target common femoral artery (other than small, diffuse deposits which in the opinion of the investigator will not impede the vascular closure procedure) within 15 mm proximal or distal to arteriotomy site based on pre-primary procedure CT angiography,
- Target femoral artery diameter is less than 7 mm, based on pre-primary procedure CT angiography,
- Further planned endovascular/catheter-based procedure in the target leg in the 30-days following the index procedure,
- Subject is enrolled in another investigational medical device or drug study,
- Subject has been previously enrolled in this clinical study,
- Current COVID-19 infection (with or without symptoms), recent positive test for COVID-19 within two weeks, or recent exposure to a person with COVID-19 infection within two weeks.
- Procedural Exclusion Criteria: If any Procedural Exclusion Criteria listed below are met, then closure with PerQseal Elite device is not permitted,
- Initial common femoral arterial access achieved with manual palpation or blind arterial stick access, without use of an image guided approach (ultrasound or angiography),
- Difficult dilation during initial target femoral artery access (e.g., that damages or kinks dilators) while step-dilating up to the large-bore device,
- During arterial puncture, the target femoral artery suspected to have experienced a posterior arterial wall needle puncture or underwent > one needle puncture during the primary procedure, with a needle larger than a micropuncture needle (> 21 gauge or > 0.819 mm diameter). (Note: not an exclusion if micropuncture technique under ultrasound guidance used for femoral artery access [Ref. 19, 20]),
- Subject has a tissue tract (i.e., estimated distance from skin entry point to arterial anterior surface at arteriotomy) expected to be greater than 8 cm,
- Significant blood loss requiring transfusion of blood products during primary procedure or within 30-days prior to index procedure,
- Activated clotting time (ACT) > 300 seconds immediately prior to sheath removal or if ACT measurements are expected to be > 300 seconds for more than 24 hours after index procedure,
- Target puncture site is in a vascular graft,
- Target arteriotomy greater than 26F,
- Target arteriotomy 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, (apex of bifurcation overlying the femoral head),
- Target arteriotomy located at the level or above the inferior epigastric artery and/or beneath or above the inguinal ligament based on bony/arterial landmarks (above femoral head on A-P projection),
- Subjects with an acute haematoma > 4 cm diameter, arteriovenous fistula, pseudoaneurysm or intraluminal thrombosis at the target access site identified intra-procedurally,
- Evidence of bleeding around the primary procedure sheath (VARC type 1/BARC type 2 or higher),
- Intra-procedural angiographic evidence of arterial laceration, dissection or stenosis within the femoral artery that would preclude use of the PerQseal Elite device,
- Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) at the time of planned vascular closure,
- Systolic blood pressure < 90 mmHg at the time of planned vascular closure. *May not be known until after the patient has given informed consent and the procedure has started. In this event, the PerQseal Elite should not be used and the patient should be considered excluded from the study and intention to treat analysis.
- Note: The use of a secondary closure device in the same leg is prohibited during this study. A note to this effect should be entered into the patient's medical records.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Investigation Plan (CIP) for: Safety and Performance Study for Arterial Large Hole Vascular Closure Device - ELITE Study
To study will assess safety and performance of the PerQseal Elite Closure Device when used with the 18F PerQseal Elite 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.
Note, for reference purposes, it is expected arteriotomies created with 14 to 22 F sheaths will create an arteriotomy in the range of 16 - 26 F (being the outer diameter of these sheaths).
Read the detailed description
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal Elite. 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.
All subjects shall have a pre-discharge, 30-Days ± 7-Days and 180-Days ± 30-Days follow-up assessment. All safety data from the study will be assessed by the Data Safety Monitoring Committee on a continuous basis.
- Conditions
- Large Hole Percutaneous Arterial Closure
- Being tested
- PerQseal ELITE
- 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.
PerQseal ELITEDevice
Percutaneous ELITE Arterial Closure Device
The term PerQseal Elite used singularly refers to the closure system comprising the closure device and Introducer. These individually are referred to as: "PerQseal Elite VCD" or "PerQseal Elite closure device" and/or "PerQseal Elite Introducer".
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device Arm (PerQseal Elite) | Experimental | Large hole percutaneous arterial closure device - PerQseal Elite Receives: Device: PerQseal ELITE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint - Major access site complications
Rate of major access site complications attributable to the PerQseal Elite device
Measured: through 30 Days
Primary Effectiveness Endpoint - Time to Haemostasis
Time to Haemostasis (TTH) defined as elapsed time in minutes from PerQseal Elite (Introducer-sheath and Delivery-device) removal to first observed cessation of common femoral artery (CFA) bleeding, excluding cutaneous or subcutaneous oozing, and in the absence of a developing haematoma.
Measured: 20 Minutes
Secondary outcomes (6)
Secondary Safety Endpoint - Incidence of Minor Access Site Complications
The Incidence of minor access site complications attributable to the PerQseal Elite device
Measured: Through 30 Days
Secondary Effectiveness Endpoint - PerQseal Elite Technical Success Rate
Defined as the number of PerQseal Elite devices that are deployed and achieve haemostasis (i.e., cessation of arterial bleeding excluding cutaneous or subcutaneous oozing) without need for more than 10 minutes of firm, adjunctive manual compression or alternative treatment (other than adjunctive endovascular ballooning) at target access site, divided by the total number of PerQseal Elite devices where deployment was attempted, within the mITT population
Measured: 10 Minutes
Secondary Effectiveness Endpoint - PerQseal Elite Treatment Success Rate
Defined as the number of subjects who meet PerQseal Elite Technical Success without experiencing a device related Major Access Site Complication (based on CEC adjudication) through 30-days, divided by the total number of subjects where PerQseal Elite device deployment was attempted, within the mITT population.
Measured: through 30 days
Secondary Effectiveness Endpoint - Time to Device Deployment
Defined as the time from insertion of the PerQseal Elite delivery device into the PerQseal Elite Introducer sheath to complete removal of the PerQseal Elite (delivery device and introducer-sheath) from the subject following PerQseal Elite deployment.
Measured: 20 Minutes
Secondary Effectiveness Endpoint - Time to Ambulation
Defined as the elapsed time from PerQseal Elite removal from the subject post deployment until the subject can walk 20 feet/6 meters without arterial re-bleeding at the target access site. This endpoint will be evaluated only for subjects who are ambulatory (e.g., not confined to wheelchair or bed) at the time of enrolment.
Measured: through 24 hours
Secondary Effectiveness Endpoint - Total Closure Time
Total Closure Time is defined as: Time to Haemostasis (TTH) plus Time to Device Deployment (TTDD).
Measured: 40 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Hole Percutaneous Arterial 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
- This study is a prospective, multicentre, single-arm study to investigate the safety and efficacy of the PerQseal Elite.
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT05951634
- Sponsor's protocol ID
- P935-00
- Acronym
- ELITE
- Status last verified
- Jul 2023
- First submitted
- 29 Jun 2023
- Last updated
- 19 Jul 2023
- 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 19 Jul 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 for Arterial Large Hole Vascular Closure Device - ELITE Study
- ClinicalTrials.gov ID
- NCT05951634
- Acronym / sponsor ID
- ELITE / P935-00
- Conditions
- Large Hole Percutaneous Arterial Closure
- Keywords
- Arterial closure, Percutaneous arterial closure, Large hole arterial closure, Large bore arterial closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vivasure Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 19 Jul 2023 (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.
To study will assess safety and performance of the PerQseal Elite Closure Device when used with the 18F PerQseal Elite 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.
Note, for reference purposes, it is expected arteriotomies created with 14 to 22 F sheaths will create an arteriotomy in the range of 16 - 26 F (being the outer diameter of these sheaths).
Detailed description
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal Elite. 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.
All subjects shall have a pre-discharge, 30-Days ± 7-Days and 180-Days ± 30-Days follow-up assessment. All safety data from the study will be assessed by the Data Safety Monitoring Committee on a continuous basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective, multicentre, single-arm study to investigate the safety and efficacy of the PerQseal Elite.
| Arm | Type | Receives |
|---|---|---|
| Investigational Device Arm (PerQseal Elite) | Experimental | Device: PerQseal ELITELarge hole percutaneous arterial closure device - PerQseal Elite |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 19 years.
- Clinically indicated for a percutaneous arterial interventional catheter-based procedure, e.g., transcatheter aortic valve replacement/implantation (TAVR/TAVI) or endovascular abdominal aortic aneurysm repair (EVAR), or thoracic endovascular aortic aneurysm repair (TEVAR), or use of a circulatory assist device or extracorporeal oxygenation using a common femoral arteriotomy created by a 14 to 22F sheath (arteriotomy up to 26F).
- Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
- Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.
Key exclusion criteria (42 listed)
- Evidence of current systemic bacterial or cutaneous infection, including groin infection,
- Known bleeding diathesis, definite or potential coagulopathy, platelet count < 100,000/µl or subjects on long term anticoagulants with an INR > 2 within 12 hours prior to index procedure,
- Significant anaemia (example: haemoglobin < 9 g/dL or haematocrit < 27%), within 24 hours prior to index procedure,
- Known type II heparin-induced thrombocytopenia,
- Documented left ventricular ejection fraction < 20%,
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 ELITEPercutaneous ELITE Arterial Closure Device The term PerQseal Elite used singularly refers to the closure system comprising the closure device and Introducer. These individually are referred to as: "PerQseal Elite VCD" or "PerQseal Elite closure device" and/or "PerQseal Elite Introducer". | Device | Investigational Device Arm (PerQseal Elite) |
Primary outcome
Primary Safety Endpoint - Major access site complications
Time frame: through 30 Days
Rate of major access site complications attributable to the PerQseal Elite device
Primary Effectiveness Endpoint - Time to Haemostasis
Time frame: 20 Minutes
Time to Haemostasis (TTH) defined as elapsed time in minutes from PerQseal Elite (Introducer-sheath and Delivery-device) removal to first observed cessation of common femoral artery (CFA) bleeding, excluding cutaneous or subcutaneous oozing, and in the absence of a developing haematoma.
6 secondary outcomes
Secondary Safety Endpoint - Incidence of Minor Access Site Complications
Time frame: Through 30 Days
Secondary Effectiveness Endpoint - PerQseal Elite Technical Success Rate
Time frame: 10 Minutes
Secondary Effectiveness Endpoint - PerQseal Elite Treatment Success Rate
Time frame: through 30 days
Secondary Effectiveness Endpoint - Time to Device Deployment
Time frame: 20 Minutes
Secondary Effectiveness Endpoint - Time to Ambulation
Time frame: through 24 hours
Secondary Effectiveness Endpoint - Total Closure Time
Time frame: 40 Minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing PerQseal ELITE in people with Large Hole Percutaneous Arterial Closure, run by Vivasure Medical Limited.
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 42 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 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 (+353 91 395 442, 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 Endpoint - Major access site complications (time frame: through 30 Days). The study lists 2 primary outcomes in all. 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 19 Jul 2023.