The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions
To evaluate the safety and efficacy of the Complete SE SFA Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Complete® SE SFA Study: The Medtronic Complete Self-Expanding SFA Stent System for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and/or Proximal Popliteal Arteries|
- MAE and Primary Patency Rates [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- MAE rate [ Time Frame: 30 days, 6 months, 24 months, 36 months ] [ Designated as safety issue: Yes ]
- Assisted primary patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Stent integrity [ Time Frame: 6, 12, 24, 36 Months ] [ Designated as safety issue: Yes ]
- Acute success (device, lesion, procedure) [ Time Frame: post procedure ] [ Designated as safety issue: Yes ]
- Change in quality of life [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- All-cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Complete SE Vascular Stent System
COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.
Device: Complete SE Vascular Stent System
Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).
The Complete Self-Expanding (SE) SFA Stent is designed to be a permanent implant. It is cut from a nickel titanium alloy (Nitinol) tube and consists of a series of segments each connected to the next in a unique pattern to allow for flexibility and vessel conformability. Each segment consists of two struts and a crown (Figure 1). It is designed to produce optimal luminal diameter and increased scaffolding, and to maintain luminal patency.
|United States, California|
|Fremont, California, United States, 94538|
|United States, Florida|
|N. Florida Regional Medical Center|
|Gainesville, Florida, United States, 32605|
|Munroe Regional Medical Center|
|Ocala, Florida, United States, 34478|
|United States, South Carolina|
|Anderson, South Carolina, United States, 29621|
|Principal Investigator:||John Laird, MD||University of California, Davis|
|Principal Investigator:||Dierk Scheinert, PD||Park-Krankenhaus Leipzig-Sudost GmbH|