Percutaneous Closure of Artery Access SitesInSealVCDNCT02628782
InSeal VCD Large Bore Vascular Closure Device Safety and Effectiveness Clinical Study
A study testing InSeal's Vascular Closure Device in people with Percutaneous Closure of Artery Access Sites, run by InSeal Medical Ltd. at 2 sites in Israel.
Trial summary
The InSeal vascular closure device (VCD) is assessed as percutaneous closure of artery access sites for quick hemostasis and ambulation in patients who have undergone large bore endovascular catheterization procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Closure of Artery Access Sites
- What is being tested?
- InSeal's Vascular Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesIsrael
- Study dates
- 29 May 2017to 22 Jan 2019
- 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
- Candidate for large bore catheterization procedure (such as TAVI, aortic endograft repair) using a CE approved 18Fr access sheath.
- Femoral, axillary or subclavian artery diameter at sheath insertion site is between 5.5-10mm
- Subject age is at least 18 years
- Patient has signed most recent approved version of the Informed Consent
- Existence of an additional arterial access port is required in instances where an occluding balloon is planned to be used as a safety precaution.
Who cannot join
- Women Of Child Bearing Potential (WOCBP)
- Legally non-competent patients
- Patient participating in another clinical study at the time of the InSeal VCD study
- Sheath insertion point is less than 12mm proximal to a bifurcation having a diameter greater than 2.5mm
- Side branch of greater than 2.5mm in diameter less than 4cm proximal to the puncture site.
- Known severe allergy to metal and membrane material
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- Prior target artery closure with a vascular closure device having intravascular component (such as Angio-Seal) 30 days prior to catheterization
- Subjects with known coagulopathy, preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to artery closure
- Patients that do not tolerate aspirin and clopidogrel anticoagulation treatment
- Prior vascular surgery or vascular graft in region of access site
- Significant calcification, atherosclerotic disease, or stent within 1.5 cm of the puncture site that may interfere with the operation of the experimental device
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Rabin Medical Center
Petah Tikva, 49100
Sheba Medical Center
Tel HaShomer, 52621
About this study
Official title: InSeal VCD Large Bore Vascular Closure Device Clinical Study
The InSeal vascular closure device (VCD) is assessed as percutaneous closure of artery access sites for quick hemostasis and ambulation in patients who have undergone large bore endovascular catheterization procedures.
The study hypothesis is that the VCD is safe and efficient in achieving hemostasis in the study population.
Read the detailed description
The increasing variety of arterial devices having a large crossing profile requiring the use of a large bore sheath is mandating focus on large bore closure. Such procedures include endovascular abdominal repair (EVAR), thoracic (TEVAR) aortic repairs and transcatheter aortic valve implantation (TAVI) typically involve sheaths and delivery catheters with 14-25Fr profiles.
Today, the typical closing technique (labeled in Europe) for such large sheath size is a one where sutures are deployed prior to the insertion of the large sheath with the sutures tied at the end of the procedure. This technique is cumbersome, hard to learn, complex to use and has relative high complications and failure rate.
The InSeal VCD device model 13-517, is easy to use, fast, affords immediate reliable hemostasis, and supports a wide range of sheath punctures size and artery's dia. 6-10 mm, while leaving a minimal amount material behind and will not limit re-access.
While each of these features may be found in one commercial device or another, to date there is no single device that meets all the market requirements.
- Being tested
- InSeal's Vascular Closure Device
- Keywords
- large bore endovascular catheterization procedures, Vascular Closure Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InSeal's Vascular Closure DeviceDevice
Intravascular closure device
| Study group | Role | What they receive |
|---|---|---|
| InSeal VCD | Experimental | InSeal's Vascular Closure Device Use of the experimental VCD to close the access site of the artery Receives: Device: InSeal's Vascular Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis within 15 minutes
Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 seconds. Measured by operator using standard time measuring device (e.g., stopwatch)
Measured: 15 minutes
Secondary outcomes (1)
Combined rate of closure-device related major adverse events
Combined rate of closure-device related major adverse events in first month as assessed by CTCAE v4.0
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study start29 May 2017
- Primary completion11 Mar 2018
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Closure of Artery Access SitesStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSeal Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ran Kornowski, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628782
- Sponsor's protocol ID
- 13-14-003I
- Acronym
- InSealVCD
- Status last verified
- Jan 2019
- First submitted
- 2 Dec 2015
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InSeal VCD Large Bore Vascular Closure Device Clinical Study
- ClinicalTrials.gov ID
- NCT02628782
- Acronym / sponsor ID
- InSealVCD / 13-14-003I
- Keywords
- large bore endovascular catheterization procedures, Vascular Closure Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- InSeal Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2017 (actual)
- Primary completion
- 11 Mar 2018 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 11 Dec 2015 (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 InSeal vascular closure device (VCD) is assessed as percutaneous closure of artery access sites for quick hemostasis and ambulation in patients who have undergone large bore endovascular catheterization procedures.
The study hypothesis is that the VCD is safe and efficient in achieving hemostasis in the study population.
Detailed description
The increasing variety of arterial devices having a large crossing profile requiring the use of a large bore sheath is mandating focus on large bore closure. Such procedures include endovascular abdominal repair (EVAR), thoracic (TEVAR) aortic repairs and transcatheter aortic valve implantation (TAVI) typically involve sheaths and delivery catheters with 14-25Fr profiles.
Today, the typical closing technique (labeled in Europe) for such large sheath size is a one where sutures are deployed prior to the insertion of the large sheath with the sutures tied at the end of the procedure. This technique is cumbersome, hard to learn, complex to use and has relative high complications and failure rate.
The InSeal VCD device model 13-517, is easy to use, fast, affords immediate reliable hemostasis, and supports a wide range of sheath punctures size and artery's dia. 6-10 mm, while leaving a minimal amount material behind and will not limit re-access.
While each of these features may be found in one commercial device or another, to date there is no single device that meets all the market requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InSeal VCD | Experimental | Device: InSeal's Vascular Closure DeviceInSeal's Vascular Closure Device Use of the experimental VCD to close the access site of the artery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Candidate for large bore catheterization procedure (such as TAVI, aortic endograft repair) using a CE approved 18Fr access sheath.
- Femoral, axillary or subclavian artery diameter at sheath insertion site is between 5.5-10mm
- Subject age is at least 18 years
- Patient has signed most recent approved version of the Informed Consent
- Existence of an additional arterial access port is required in instances where an occluding balloon is planned to be used as a safety precaution.
Key exclusion criteria (11 listed)
- Women Of Child Bearing Potential (WOCBP)
- Legally non-competent patients
- Patient participating in another clinical study at the time of the InSeal VCD study
- Sheath insertion point is less than 12mm proximal to a bifurcation having a diameter greater than 2.5mm
- Side branch of greater than 2.5mm in diameter less than 4cm proximal to the puncture site.
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 |
|---|---|---|
| InSeal's Vascular Closure DeviceIntravascular closure device | Device | InSeal VCD |
Primary outcome
Hemostasis within 15 minutes
Time frame: 15 minutes
Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 seconds. Measured by operator using standard time measuring device (e.g., stopwatch)
1 secondary outcome
Combined rate of closure-device related major adverse events
Time frame: 1 month
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 12 Feb 2020.
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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.
Ran Kornowski, MD principal investigator
Rabin Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InSeal's Vascular Closure Device in people with Percutaneous Closure of Artery Access Sites, run by InSeal Medical Ltd. at 2 sites in Israel.
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 5 inclusion and 11 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Hemostasis within 15 minutes (time frame: 15 minutes). 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 12 Feb 2020.