Status:
TERMINATED
InSeal Vascular Closure Device Clinical Study Protocol
Lead Sponsor:
InSeal Medical Ltd.
Conditions:
Percutaneous Closure of Artery Access Sites
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 catheteriz...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01896401
Start Date
February 1 2012
End Date
August 1 2015
Last Update
February 23 2016
Active Locations (1)
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1
Cardio Vascular Centrum Frankfurt
Frankfurt, Germany, 60389