DRAFT: This module has unpublished changes.


Isolated Independent Variable:

Stent device to be used (metallic, steel, cobalt chromium, nitinol memory metal).

Control Group (Placebo/subject not treated with Independent Variable):

A healthy, intact, blood vessel. Knowledge of conditions present in such an environment would
then act as a base upon which to compare vessels with device intervention.

Dependent Variable (How affects of Independent Variable on subject is measured):

Reaction of vessel and device interaction, such as vessel tissue changes and signs of stent
fatigue and/or fracture. Measured based on degree of failure (scale of 1-5 for stent fracture) and
magnitude (mm measurements for vessel occlusions) (OCT and Micro-CT scanning modalities
utilized to gain highly precise, accurate images of implant sites).

Thesis (Statement of “Independent Variable” will affect “Dependent Variable” in XXX way:

Stents vary in both their material and mechanical design; by understanding how each individual
aspect of a device affects its surrounding environment, the cause behind vascular change and
failure following stent implantation could be better understood, allowing greater regulatory and
research-based action to occur.

Overall Project Intention (Reason behind testing thesis):

By analyzing device-tissue environment relationships, conclusions can be drawn on the affects
of specific areas of a stent (strut, joint, area of overlapping) on the health of surrounding tissue
(Production of lesions, vessel occlusion, etc).

Name of Intern Mitchell Baker_____________________________

Mentor Site FDA - CDRH_________________________________

Leadership Board Present/Recommendation

DRAFT: This module has unpublished changes.