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

Morris Innovative

Status

Unknown

Conditions

Vascular Diseases

Treatments

Device: FISH SP

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03412942

2K17-10

Details and patient eligibility

About

A single-center, prospective, cohort analysis of the Femoral Introducer Sheath and Hemostasis (FISH) vascular closure device will study 100 consecutive patients on which the device will be used to close the femoral artery after angiogram and/or endovascular procedure. Study will be conducted in order to establish the level of comfort and confidence that this device provides for both patients and physician in terms of hemodynamic and usage outcomes.

Full description

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)

Enrollment

100 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.).