EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort (ELITE)

The learning experience of new medical device technologies is a well-defined event but varies
widely by device and user. Several factors influence rate of learning, including the device,
the patient population the training technique, clear communication, and the rate of usage.
Previous publication have reported on the learning curve of vascular closure technologies
including; AngioSeal, Perclose & StarClose. These reports established the curve to be close
to 50 experiences in order to provide predictable results.

Many prior studies have studied the safety and efficacy of vascular closure devices. However,
it is substantial to also study device success when in the hands of one specific operator.
This study will examine 100 consecutive subjects which the FISH vascular closure device will
be used on, and examine outcomes in the following way:

Primary Endpoint:

o Safety: Severe adverse events rate (SAE) (Device related only) (transfusion/vessel
occlusion)

Secondary Endpoints:

- Safety: minor adverse event rate (MAE) (Hematoma)

- Success rate (Time to Hemostasis (TTH) < 10min)

- Time to Hemostasis (TTH) mm:ss - measured from sheath pull to absence of arterial
bleeding.

- Time to Ambulation (TTA) hh:mm - measured form sheath pull to walking 20 feet.

- Patient comfort - subjective measure (see scale below) measured baseline (pre-procedure/
post procedure/ 15 days and 30 days)

- Physician Confidence and Comfort (C&C)(measured every 10 patients)

Inclusion Criteria:

- All patients on which a FISH device will be used for vascular closure, deemed
appropriate by the Principal Investigator.

Exclusion Criteria:

- Patients on which a FISH device will not be used for vascular closure and another
method will be used - deemed appropriate by the Principal Investigator (i.e. manual
compressions, PerClose, AngioSeal, etc.).