NCT01292928

SuperNOVA Clinical Stenting Trial

Stenting of the Superficial Femoral (SFA) and Proximal Popliteal Arteries (PPA) With the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Atherosclerosis of Native Arteries of the Extremities, Unspecified

Interventions

Type	Name	Description
DEVICE	Stent implantation	Stent implantation during the index procedure.

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-07-01
• Completion: 2016-09-01
• First posted: 2011-02-10
• Last updated: 2017-03-08
• Results posted: 2016-01-20

Locations

49 sites across 7 countries: United States, Austria, Belgium, Canada, Germany, Japan, United Kingdom