Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
33 participants
INTERVENTIONAL
2012-02-29
2015-08-31
Brief Summary
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The study hypothesis is that the VCD is safe and efficaient in achieving hemostasis in the study population.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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InSeal's Vascular Closure Device
Use of the experimental VCD to close the access site of the artery
InSeal's Vascular Closure Device
Interventions
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InSeal's Vascular Closure Device
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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InSeal Medical Ltd.
INDUSTRY
Responsible Party
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Locations
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Cardio Vascular Centrum Frankfurt
Frankfurt, , Germany
Countries
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Other Identifiers
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13-14-003
Identifier Type: -
Identifier Source: org_study_id
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