InSeal Vascular Closure Device Clinical Study Protocol (VCD)

InSeal Medical

Status

Terminated

Conditions

Percutaneous Closure of Artery Access Sites

Treatments

Device: InSeal's Vascular Closure Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT01896401

13-14-003

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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