groin closure Vascular closure device
Conditions
Interventions
None listed
Sponsors
Inseal Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Candidate for large bore catheterization procedure (such as TAVI, aortic endograft repair) using a CE approved 18Fr access sheath. 2. Femoral, axillary or subclavian artery diameter at sheath insertion site is between 6-10mm 3. Subject age is at least 18 years 4. Patient has signed most recent approved version of the Informed Consent 5. 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
Exclusion criteria: 1. Women Of Child Bearing Potential (WOCBP) 2. Legally non-competent patients 3. Patient participating in another clinical study at the time of the InSeal VCD study 4. Sheath insertion point is less than 12mm proximal to a bifurcation having a diameter greater than 2.5mm 5. Side branch of greater than 2.5mm in diameter less than 4cm proximal to the puncture site. 6. Known severe allergy to metal and membrane material 7. Prior target artery closure with a vascular closure device having intravascular component (such as Angio-Seal) 30 days prior to catheterization 8. Subjects with known coagulopathy, preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to artery closure 9. Patients that do not tolerate aspirin and clopidogrel anticoagulation treatment 10. Prior vascular surgery or vascular graft in region of access site 11. Significant calcification, atherosclerotic disease, or stent within 1.5 cm of the puncture site that may interfere with the operation of the experimental device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint are: 1. Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 seconds 2. Combined rate of closure-device related major adverse events in first month | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is: 1. Demonstration of delivery system functionality | — |
Countries
Netherlands
Outcome results
None listed