SuperNOVA Clinical Stenting Trial
Atherosclerosis of Native Arteries of the Extremities, Unspecified
Device: Stent implantation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Stenting of the Superficial Femoral (SFA) and Proximal Popliteal Arteries (PPA) With the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System|
- Primary Safety Endpoint and Components [ Time Frame: 1 month for death, 12 months for target limb major amputation , and target lesion revascularization ]The safety endpoint assesses the occurrence of Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months
- Co-Primary Efficacy Endpoints [ Time Frame: 12 months ]
The co-primary efficacy endpoints assess vessel primary patency at 12 months post-procedure.
- The co-primary efficacy analysis (1) will assess vessel primary patency in stented segments intended to be treated with core matrix stents (20 to 150 mm).
- The co-primary efficacy analysis (2) will assess vessel primary patency in stented segments intended to be treated with the entire stent matrix (20 to 200 mm).
- Secondary Safety Endpoint and Components [ Time Frame: 1 month ]The secondary safety endpoint assesses the occurrence of Major Adverse Events (MAEs) through 30 days. MAEs will include all causes of death, target limb major amputation and/or target lesion revascularization through 1 month
- Technical and Procedural Success [ Time Frame: Up to 24 hours after the procedure ]
- Technical success: ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%
- Procedural success: technical success with no MAEs within 24 hours of the procedure
- Primary Patency [ Time Frame: 12 months ]Primary patency is the percentage of lesions (target stented segments) that reach a time point without a hemodynamically significant stenosis assessed by Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or bypass of the target lesion.
- Assisted Primary Patency [ Time Frame: 12 months ]Assisted primary patency is the percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach a time point without restenosis.
- Stent Fracture Rate [ Time Frame: 12 months ]
Vascular InterVentional Advances (VIVA) definitions:
Grade 0: No strut fractures
Grade I: single strut fracture
Grade II: multiple strut fractures
Grade III: stent fracture(s) with preserved alignment of the components
Grade IV: stent fracture(s) with mal-alignment of the components
Grade V: stent fracture(s) in a trans-axial spiral configuration
- Rutherford Classification [ Time Frame: 12 months ]
Class 0: Asymptomatic
Class 1: Mild claudication
Class 2: Moderate claudication
Class 3: Severe claudication
Class 4: Ischemic rest pain
Class 5: Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal edema
Class 6: Major tissue loss - extending above metatarsal (MT) level
Rate of Primary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure without the need for repeat TLR.
Rate of Secondary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR.
Rate of Clinical Deterioration: downgrade in Rutherford classification of one or more categories as compared to pre-procedure
- Rate of Hemodynamic Improvement [ Time Frame: 12 months ]
The Ankle-Brachial Index (ABI) is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm.
Hemodynamic Improvement: Increases in ABI of ≥ 0.10 or to an ABI ≥ 0.90 as compared to pre-procedure without the need for repeat TLR.
Hemodynamic Improvement (Including TLR): Increases in ABI of ≥0.10 or to an ABI ≥0.90 as compared to pre-procedure including TLR.
- Walking Improvement Assessed by the Walking Impairment Questionnaire [ Time Frame: 12 months ]The Walking Impairment Questionnaire (WIQ) is a validated functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
- Walking Improvement (Time) Assessed by 6 Minute Hall Walk [ Time Frame: 12 months ]Assessment of walking improvement by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.
- Quality of Life [ Time Frame: 12 months ]Improved Quality of Life assessed by the SF-36 Health Survey. The validated SF-36 Survey, where scores are calibrated so that 50 is the average score or norm, was utilized (scores ranging from 0, worst possible health to 100, best possible health). The SF-36 is a multipurpose, proprietary health survey with 36 questions that yield eight health component scales that can be further summarized into two summary scores: mental and physical health scores. The eight health component scales that can be computed from the questionnaire are physical function, role-physical, bodily pain, general health, vitality, role-emotional, mental health and social functioning.
- Walking Improvement (Distance) Assessed by 6 Minute Hall Walk [ Time Frame: 12 months ]Assessment of walking improvement by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||November 2016|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292928
Show 49 Study Locations
|Principal Investigator:||Richard J Powell, MD||Dartmouth-Hitchcock Medical Center|