Percutaneous Closure of Artery Access SitesVCDNCT01896401
InSeal Vascular Closure Device Clinical Study Protocol
A study testing InSeal's Vascular Closure Device in people with Percutaneous Closure of Artery Access Sites, run by InSeal Medical Ltd. at 1 site in Germany.
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
- 33 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Aug 2015
- 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.
- 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
- 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
1 site in 1 country.
About this 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 efficaient in achieving hemostasis in the study population.
- 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
| Study group | Role | What they receive |
|---|---|---|
| InSeal's Vascular Closure Device | Experimental | 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.
1. Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 second
Measured: 15 minutes
Secondary outcomes (1)
2. Combined rate of closure-device related major adverse events in first month
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 Jul 2013 (estimated)
- Study startFeb 2012
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Initiated a new study with improved device
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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSeal Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896401
- Sponsor's protocol ID
- 13-14-003
- Acronym
- VCD
- Status last verified
- Feb 2016
- First submitted
- 6 Jul 2013
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InSeal Vascular Closure Device Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT01896401
- Acronym / sponsor ID
- VCD / 13-14-003
- Keywords
- large bore endovascular catheterization procedures, Vascular Closure Device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Initiated a new study with improved device
- Enrolment
- 33 participants (actual)
- Lead sponsor
- InSeal Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Jul 2013 (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 efficaient in achieving hemostasis in the study population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InSeal's Vascular Closure Device | Experimental | Device: InSeal's Vascular Closure DeviceUse 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 (4 listed)
- Candidate for large bore catheterization procedure (such as TAVI, aortic endograft repair) using a CE approved 18Fr access sheath.
- 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 (8 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
- 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
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 Device | Device | InSeal's Vascular Closure Device |
Primary outcome
1. Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 second
Time frame: 15 minutes
1 secondary outcome
2. Combined rate of closure-device related major adverse events in first month
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Initiated a new study with improved device). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 1 site 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 8 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: stopped early, as of the sponsor's last update on 23 Feb 2016. 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 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 was stopped early (reason given: Initiated a new study with improved device). Results are not available in the source record.
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?
1. Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 second (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 23 Feb 2016.