The objectives of this study are to:• To demonstrate the safety of the InSeal VCD implant. • To demonstrate the safety and functionality of the InSeal VCD delivery system in delivering and deploying of the InSeal VCD implant and withdrawal of the…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
The secondary endpoint is:
1. Demonstration of delivery system functionality
Background summary
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, thoracic aortic
repairs and transcatheter aortic valve implantation typically involve sheaths
and delivery catheters with 18-25Fr profiles.
Today, the only closing technique (labeled in Europe) available for such large
sheath size is the Preclose technique using the 10Fr Perclose Prostar XL. In
this technique the Prostar 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 is easy to use, fast, affords immediate reliable
hemostasis, and a single device supports a wide range of sheath punctures size,
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 objective
The objectives of this study are to:
• To demonstrate the safety of the InSeal VCD implant.
• To demonstrate the safety and functionality of the InSeal VCD delivery system
in delivering and deploying of the InSeal VCD implant and withdrawal of the
delivery system.
• To demonstrate the effectiveness of the InSeal VCD system in achieving
closure
Study design
Prospective, non-randomized study.
Study burden and risks
It cannot be excluded that the InSeal VCD system does not work and the artery
needs to be closed surgically. In addition, there may be a thrombosis,
resulting in a narrowing of the artery.
Halamish St 7
Halamish 38900
IL
Halamish St 7
Halamish 38900
IL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45921.078.13 |