None listed
Conditions
Brief summary
The primary objective of this study is to evaluate the safety and technical feasibility of the Arterica Closure Device (ACD). The device is being used in this study so that the Sponsor (Arterica) and study staff can learn about the potential use of the product. This device has been designed to close large-bore vascular (blood vessels) access sites following endovascular or interventional procedures. Researchers are evaluating if the device is safe to use and if it shows potential of closing large-bore access sites.
Interventions
The device used is the Arterica Closure Device (ACD). The ACD is a medical device used to close large-bore vascular access sites following endovascular or interventional procedures. It is a handheld device operated by a trained clinician or doctor. The device has a handle and a nose with an extended tip. The tip of the device is inserted into the access site where it brings together the surrounding tissue and closes the wound.
The investigational procedure will be performed in an operation roo
The device used is the Arterica Closure Device (ACD). The ACD is a medical device used to close large-bore vascular access sites following endovascular or interventional procedures. It is a handheld device operated by a trained clinician or doctor. The device has a handle and a nose with an extended tip. The tip of the device is inserted into the access site where it brings together the surrounding tissue and closes the wound. The investigational procedure will be performed in an operation room or catherization lab, by an experienced and trained device operator. The ADC procedure will take approximately 30 minutes. The device must be used per the Instructions for Use. The sponsor will ensure all device operators are trained.
Sponsors
Arterica, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subject is >18 years of age at time of consent Subject is scheduled for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedures involving access through the common femoral artery
Exclusion criteria
Subject is pregnant or lactating Subject has known bleeding disorder Subject has recent history of common femoral artery closure with any common femoral artery closure device or any open procedure in the target groin. Subject has recent history of common femoral artery closure with manual compression. Subject unable to ambulate. Subject has a unilateral or bilateral lower extremity amputation
Outcome results
None listed