Large Hole Percutaneous Venous ClosureELITE-VenousNCT06007339
PerQseal® Elite Venous Clinical Study (ELITE-Venous)
A study testing PerQseal ELITE in people with Large Hole Percutaneous Venous Closure, run by Vivasure Medical Limited at 1 site in Netherlands.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite vascular closure system when used to achieve haemostasis of common femoral venotomies created by 14 to 22F sheaths (venotomy up to 26F) in patients undergoing percutaneous catheter-based interventional procedures, with… 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 Venous 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
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 venous interventional catheter-based procedure, e.g., mitral valve edge to edge repair, left atrial appendage device closure, leadless pacemaker implantation, patent foramen ovale closure or use of a circulatory assist device or extracorporeal oxygenation using a common femoral venotomy created by a 14 to 22F sheath (venotomy 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.
- Baseline Exclusion Criteria:
- Evidence of current systemic bacterial or cutaneous infection, including groin infection,
Show all 46Show fewer
- Known bleeding diathesis, unstable INR, definite or potential coagulopathy, platelet count < 100,000/μl or subjects on long term anticoagulants with an INR > 2.2 within 12 hours prior to index procedure,
- Significant anaemia (example: haemoglobin < 8 g/dL or haematocrit < 22%), within 24 hours prior to index procedure,
- Known type II heparin-induced thrombocytopenia,
- Documented right ventricular dysfunction < 13%,
- Ipsilateral or contralateral lower extremity amputation,
- Previous groin surgery within the region of the ipsilateral vessel access,
- Common femoral vein diameter stenosis > 50% or previous bypass surgery/stent placement in the common femoral vein of target leg,
- Known existing nerve damage in the target leg,
- Nephrotic syndrome or renal insufficiency (Glomerular Filtration Rate ≤ 30 ml/min or baseline serum creatinine > 2.5 mg/dl) or on renal replacement therapy or albumin level < 3.5 g/dl or symptoms of pitting oedema,
- Systolic pulmonary artery pressure > 60 mmHg
- 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 vessel, 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 vessel, 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 vessel, within the 30-days prior to index procedure,
- History of DVT or pulmonary embolism or venous thrombotic event,
- Splenectomy or suffering psoriasis or paraesthesia of the ipsilateral leg,
- 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,
- Subject is unable to maintain ipsilateral leg still during the index procedure (restless leg syndrome),
- 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:
- Anatomically the common femoral vein is substantially posterior to the femoral artery, confirmed by Duplex ultrasound,
- Initial common femoral venous access achieved other than with the use of an ultrasound guided access approach,
- If the venous access is, or suspected of being, via an artery,
- Difficult dilation during initial target femoral vein access (e.g., that damages or kinks dilators) while step-dilating up to the large-bore device,
- During venous puncture, the target femoral vein suspected to have experienced a posterior venous 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 vein access [Ref. 30, 31]),
- Subject has a tissue tract (i.e., estimated distance from skin entry point to venous anterior surface at venotomy) 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) > 250 seconds immediately prior to sheath removal or if ACT measurements are expected to be > 250 seconds for more than 24 hours after index procedure,
- Target puncture site is in a vascular graft,
- Target venotomy greater than 26F,
- Target femoral vein diameter is less than 7 mm, based on Duplex ultrasound or angiography,
- Evidence of venous diameter stenosis > 20% within 15 mm proximal or distal to venotomy site based on Duplex ultrasound or angiography,
- Target venotomy has been made in the superficial femoral vein, profunda femoris vein (deep femoral vein), great saphenous vein or located less than 15 mm distal (cranial) to the bifurcation of either the profunda femoris or great saphenous vein and common femoral vein,
- Target venotomy located behind (posterior) or above (cranial) to the inguinal ligament based upon bony 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 or Duplex ultrasound) evidence of venous laceration, dissection or stenosis within the femoral vein that would preclude use of the PerQseal Elite device,
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus UMC
Rotterdam, Rotterdam
Nicolas Van Mieghem, MD, +31 10 704 0 704, n.vanmieghem@erasmusmc.nl
About this study
Official title: Safety and Performance Study for Venous Large Hole Vascular Closure Device - ELITE Study
The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite vascular closure system when used to achieve haemostasis of common femoral venotomies created by 14 to 22F sheaths (venotomy up to 26F) in patients undergoing percutaneous catheter-based interventional procedures, with sufficient rigor to provide robust scientific evidence for the demonstration of clinical safety and efficacy of the PerQseal Elite closure system to support a CE-mark and a PMA submission.
Read the detailed description
This study is a prospective, multicentre, single-arm study to investigate the safety and efficacy of the PerQseal Elite in up to 97 patients at up to 12 European investigational sites. The study shall not be blinded prior to, during or post the procedure. Patients undergoing a percutaneous catheter-based venous interventional procedure (e.g., mitral valve repair, leadless pacemaker implantation, circulatory assist or ECMO via large bore femoral vein catheter) requiring a venotomy created by 14 to 22F sheaths (venotomies up to 26F), via the common femoral vein will be screened against the study inclusion/exclusion criteria.
All subjects shall have a 30-minute, 60-minute, pre-discharge (~48 hours), 30-Days ± 7-Days and 180-Days ± 30-Days follow-up assessments.
All safety data from the study will be assessed by the Data Safety Monitoring Committee on a continuous basis.
- Conditions
- Large Hole Percutaneous Venous Closure
- Being tested
- PerQseal ELITE
- Keywords
- Venous Closure, Percutaneous closure, Large bore closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerQseal ELITEDevice
Also called Percutaneous ELITE Venous 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- Venous) | Experimental | Large hole percutaneous venous 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- Combined rate of both Major and Minor access site complications
the combined rate of both Major and Minor access site complications attributable to the PerQseal Elite device§ through 30-days, as adjudicated by the Clinical Events Committee (CEC) as study device related.
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 vein (CFV) bleeding (clinically acceptable cessation of venous bleeding), excluding cutaneous or subcutaneous oozing, and in the absence of a developing haematoma. This is assessed at the end of the index procedure prior leaving the operating room/catheterisation laboratory.
Measured: 20 Minutes
Secondary outcomes (5)
Secondary Effectiveness Endpoint - PerQseal Elite Technical Success Rate
PerQseal Elite Technical Success Rate is defined as the number of PerQseal Elite devices that are deployed and achieve haemostasis (i.e., cessation of venous 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.
Measured: 10 Minutes
Secondary Effectiveness Endpoint - PerQseal Elite Treatment Success Rate
PerQseal Elite Treatment Success Rate is defined as the number of subjects who meet PerQseal Elite Technical Success without experiencing a device related Access Site Complication (based on CEC adjudication) through 30-days, divided by the total number of subjects where PerQseal Elite device deployment was attempted.
Measured: through 30 days
Secondary Effectiveness Endpoint -Time to Device Deployment (TTDD)
Time to Device Deployment is 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
Time to Ambulation is defined as: the elapsed time from PerQseal Elite removal from the subject post deployment until the subject can walk 20 feet/6 meters without venous 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 posted23 Aug 2023
- Study start1 Apr 2024
- Primary completionSep 2025 (estimated)
- Study completionDec 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 Venous 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
- 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
- NCT06007339
- Sponsor's protocol ID
- P934-00
- Acronym
- ELITE-Venous
- Status last verified
- Mar 2025
- First submitted
- 17 Aug 2023
- Last updated
- 26 Mar 2025
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Study for Venous Large Hole Vascular Closure Device - ELITE Study
- ClinicalTrials.gov ID
- NCT06007339
- Acronym / sponsor ID
- ELITE-Venous / P934-00
- Conditions
- Large Hole Percutaneous Venous Closure
- Keywords
- Venous Closure, Percutaneous closure, Large bore closure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Vivasure Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Aug 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.
The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite vascular closure system when used to achieve haemostasis of common femoral venotomies created by 14 to 22F sheaths (venotomy up to 26F) in patients undergoing percutaneous catheter-based interventional procedures, with sufficient rigor to provide robust scientific evidence for the demonstration of clinical safety and efficacy of the PerQseal Elite closure system to support a CE-mark and a PMA submission.
Detailed description
This study is a prospective, multicentre, single-arm study to investigate the safety and efficacy of the PerQseal Elite in up to 97 patients at up to 12 European investigational sites. The study shall not be blinded prior to, during or post the procedure. Patients undergoing a percutaneous catheter-based venous interventional procedure (e.g., mitral valve repair, leadless pacemaker implantation, circulatory assist or ECMO via large bore femoral vein catheter) requiring a venotomy created by 14 to 22F sheaths (venotomies up to 26F), via the common femoral vein will be screened against the study inclusion/exclusion criteria.
All subjects shall have a 30-minute, 60-minute, pre-discharge (~48 hours), 30-Days ± 7-Days and 180-Days ± 30-Days follow-up assessments.
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- Venous) | Experimental | Device: PerQseal ELITELarge hole percutaneous venous 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 (46 listed)
- Age ≥ 19 years.
- Clinically indicated for a percutaneous venous interventional catheter-based procedure, e.g., mitral valve edge to edge repair, left atrial appendage device closure, leadless pacemaker implantation, patent foramen ovale closure or use of a circulatory assist device or extracorporeal oxygenation using a common femoral venotomy created by a 14 to 22F sheath (venotomy 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.
- Evidence of current 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 |
|---|---|---|
| PerQseal ELITEAlso: Percutaneous ELITE Venous Closure DeviceThe 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- Venous) |
Primary outcome
Primary Safety Endpoint- Combined rate of both Major and Minor access site complications
Time frame: through 30 Days
the combined rate of both Major and Minor access site complications attributable to the PerQseal Elite device§ through 30-days, as adjudicated by the Clinical Events Committee (CEC) as study device related.
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 vein (CFV) bleeding (clinically acceptable cessation of venous bleeding), excluding cutaneous or subcutaneous oozing, and in the absence of a developing haematoma. This is assessed at the end of the index procedure prior leaving the operating room/catheterisation laboratory.
5 secondary outcomes
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 (TTDD)
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PerQseal ELITE in people with Large Hole Percutaneous Venous Closure, run by Vivasure Medical Limited at 1 site in Netherlands.
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 46 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: looking for participants now, as of the sponsor's last update on 26 Mar 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
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- Combined rate of both Major and Minor 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 26 Mar 2025.