SuperNOVA Clinical Stenting Trial
The primary objective of this clinical study is to determine whether the Innova Stent System shows acceptable performance in long-term (12-month) safety rates and vessel patency when treating femoropopliteal lesions.
Atherosclerosis of Native Arteries of the Extremities, Unspecified
Device: Stent implantation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Stenting of the Superficial Femoral and Proximal Popliteal Arteries With the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System|
- Safety Rate/Vessel patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]The primary objective of this clinical study is to determine whether the Innova Stent System shows acceptable performance in long-term (12-month) safety rates and vessel patency when treating femoropopliteal lesions.
- Additional Data [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Secondary objectives of this clinical study are to provide additional data surrounding the use of the Innova Stent System in treating femoropopliteal lesions, inclusive of an assessment of any quality of life improvement noted by the subjects, clinical improvement documented by the Investigators, and an evaluation of stent fractures.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Stent implantation into SFA/PPA
Device: Stent implantation
Stent implantation during the index procedure.
Atherosclerosis is a systemic disease that has become increasingly recognized in the expanding elderly population as a significant cause of morbidity and mortality. Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms ranging from intermittent claudication to ischemic rest pain and critical ischemia with major tissue loss. Typically, femoropopliteal lesions have been difficult to successfully treat with endovascular therapy because the disease is often diffuse and located in an area of the body subject to significant mobility stresses such as extension, contraction, compression, elongation, flexion and torsion.
The SuperNOVA clinical study is a prospective, single arm, controlled, multicenter, global study. Approximately 50 centers located in the United States, Europe, Canada and/or Australia are expected to participate in recruiting patients needing treatment of lesions in their femoropopliteal arteries. A maximum of 300 subjects will be enrolled to ensure that a minimum of 296 stented segments are treated with the Innova Stent System.
Show 49 Study Locations
|Principal Investigator:||Richard J Powell, MD||Dartmouth-Hitchcock Medical Center|