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Percutaneous Large Hole Vascular ClosurePATCHNCT05653336

PerQseal® Clinical Study

A study testing PerQseal® Closure Device System in people with Percutaneous Large Hole Vascular Closure, run by Vivasure Medical Limited at 18 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective is to evaluate the safety and effectiveness of the PerQseal vascular closure device system when used to achieve haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (arteriotomy up to 26 F) in subjects undergoing percutaneous catheter-based interventional procedures. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Percutaneous Large Hole Vascular Closure
What is being tested?
PerQseal® Closure Device System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
149 participants
Where
18 sitesin 2 countries
Study dates
30 Mar 2023to Jun 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
  • No healthy volunteers
  • 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 12 to 22 F sheath (arteriotomy up to 26 F),
  • 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 44Show fewer
  • 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 (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%,
  • Ipsilateral or contralateral lower extremity amputation.
  • 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 device (refer to Instructions for Use),
  • Subject unsuitable for surgical repair of the target leg access site,
  • Subject has undergone a percutaneous procedure greater than 8 F sheath in the target leg, within the 90-days prior to index procedure,
  • Subject has undergone a percutaneous procedure of 8 F 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 8 F 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 > 30% 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 6 mm or 7 mm, depending on whether S (small) or L (large) PerQseal Introducer will be used for arteriotomy closure, respectively, 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 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) )
  • 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) > 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 arteriotomy greater than 26 F,
  • 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,
  • 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 type1/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 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.

Who cannot join

None listed.

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

United States15 sites

  • Northern Light Eastern Maine Medical Center

    Bangor, Maine, 04401

  • University of Buffalo

    Buffalo, New York, 14203

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • The Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Texas Heart Institute

    Houston, Texas, 77030

  • Scripps

    La Jolla, California, 92037

  • UPMC Pinnacle Health

    Mechanicsburg, Pennsylvania, 17050

  • Columbia University Medical Center/ NewYork Presbyterian Hospital

    New York, New York, 10032

  • The Valley Hospital

    Paramus, New Jersey, 07652

  • UPenn - Perelman Center for Advanced Medicine,

    Philadelphia, Pennsylvania, 19104

  • University of Rochester Medical Center

    Rochester, New York, 14623

  • HonorHealth

    Scottsdale, Arizona, 85258

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Montefiore Medical Center (multiple centers)

    The Bronx, New York, 10461

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Germany3 sites

  • St. Gertrauden Krankenhaus (SGK)

    Berlin, 10713

  • Leipzig University Hospital

    Leipzig, Saxony, 04103

  • St Franziskus Hospital

    Münster, North Rhine-Westphalia

Other trials in Germany

About this study

Official title: A Multicentre, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the Vivasure PerQseal® Closure Device System When Used to Achieve Haemostasis of Common Femoral Arteriotomies Created by 12 to 22 F Sheaths in Patients Undergoing Percutaneous Catheter-Based Interventional Procedures

The objective is to evaluate the safety and effectiveness of the PerQseal vascular closure device system when used to achieve haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (arteriotomy up to 26 F) in subjects undergoing percutaneous catheter-based interventional procedures.

Read the detailed description

The objective of this pivotal study is to evaluate the safety and effectiveness of the PerQseal vascular closure device system when used to achieve haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (arteriotomy up to 26 F) in subjects 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 closure system to support a pre-market approval submission.

Being tested
PerQseal® Closure Device System
Keywords
Vascular Closure, Vascular Closure Device, Large hole percutaneous closure, Large bore percutaneous closure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PerQseal® Closure Device SystemDevice

    Bioabsorbable implant delivered percutaneously to achieve haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (up to 26 F arteriotomy) in patients undergoing percutaneous catheter-based interventional procedures.

Study groups in NCT05653336
Study groupRoleWhat they receive
Subjects implanted with PerQseal Vascular Closure DeviceExperimentalSubjects implanted with bioabsorbable implant to achieve haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (up to 26 F arteriotomy) in patients undergoing percutaneous catheter-based interventional procedures.
Receives: Device: PerQseal® Closure Device System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety Endpoint - Major Access Site Complications

    Rate of major access site complications attributable to the PerQseal device

    Measured: through 30 days

  2. Primary Effectiveness Endpoint - Time to Hemostasis

    Elapsed time in minutes from PerQseal (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)

  1. Secondary Safety Endpoint - Minor Access Site Complications

    Incidence of minor access site complications attributable to the PerQseal device

    Measured: through 30 Days

  2. Secondary Effectiveness Endpoint - PerQseal Technical Success Rate

    Defined as the number of PerQseal 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 devices where deployment was attempted. This is a per device endpoint.

    Measured: 10 Minutes

  3. Secondary Effectiveness Endpoint - PerQseal Treatment Success Rate

    Defined as the number of subjects who meet PerQseal Technical Success without experiencing a device related Major Access Site Complication through 30-days, divided by the total number of subjects where PerQseal device deployment was attempted.

    Measured: through 30 days

  4. Secondary Effectiveness Endpoint - Time to Device Deployment

    Defined as the time from insertion of the PerQseal delivery device into the PerQseal Introducer sheath to complete removal of the PerQseal (delivery device and introducer-sheath) from the subject following PerQseal deployment.

    Measured: 20 Minutes

  5. Secondary Effectiveness Endpoint - Time to Ambulation

    Defined as the elapsed time from PerQseal removal 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 time of enrolment.

    Measured: through 24 hours

  6. Secondary Effectiveness Endpoint - Total Closure Time

    Defined as time to Haemostasis plus Time to Device Deployment.

    Measured: 40 Minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2022
  2. Study start30 Mar 2023
  3. Primary completion16 Dec 2024
  4. Study completionJun 2025 (estimated)

Resources

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
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05653336
Sponsor's protocol ID
P696-00
Acronym
PATCH
Status last verified
Jan 2025
First submitted
7 Dec 2022
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PerQseal® Closure Device System in people with Percutaneous Large Hole Vascular Closure, run by Vivasure Medical Limited at 18 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 44 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: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, 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?

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?

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?

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?

On the ClinicalTrials.gov record for NCT05653336.

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 28 Jan 2025.

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