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SuperNOVA Clinical Stenting Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01292928
First received: February 9, 2011
Last updated: September 12, 2016
Last verified: September 2016
Results First Received: August 14, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Atherosclerosis of Native Arteries of the Extremities, Unspecified
Intervention: Device: Stent implantation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 299 subjects were enrolled and treated with the Innova™ Self-Expanding Stent System in this prospective, single-arm, non-randomized clinical study at 49 investigative centers in The Unites States, Canada, Japan and Europe, from 1 April 2011 to 28 June 2013 (with a temporary enrollment suspension from 13 May 2011 to 25 April 2012)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Innova Stent Stent implantation into Superficial Femoral Artery (SFA) / Proximal Popliteal Artery (PPA)

Participant Flow:   Overall Study
    Innova Stent
STARTED   299 
Completed 12-Month Clinical Follow-up   266 
COMPLETED   275 
NOT COMPLETED   24 
Death                8 
Withdrawal by Subject                8 
Lost to Follow-up                6 
Physician Decision                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Innova Stent Stent implantation into SFA/PPA

Baseline Measures
   Innova Stent 
Overall Participants Analyzed 
[Units: Participants]
 299 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.4  (9.7) 
Gender 
[Units: Participants]
 
Female   77 
Male   222 
Race/Ethnicity, Customized 
[Units: Participants]
 
Hispanic or Latino   4 
Caucasian   238 
Asian (Japanese)   42 
Black, or African heritage   13 
Native Hawaiian or other Pacific Islander   1 
American Indian or Alaska Native   1 
Region of Enrollment 
[Units: Participants]
 
Canada   31 
Austria   6 
Belgium   52 
United States   117 
Japan   42 
United Kingdom   7 
Germany   44 
General Medical History [1] 
[Units: Participants]
 
History of Smoking   251 
Current Diabetes Mellitus   121 
Medically-Treated Diabetes   105 
History of Hyperlipidemia requiring medication   224 
History of Hypertension requiring medication   239 
History of Chronic Obstructive Pulmonary Disease   25 
[1] The same participant may be included in more than one category or not all participants may contribute to a category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Cardiac History [1] 
[Units: Participants]
 
History of Coronary Artery Disease   130 
History of Myocardial Infarction (MI)   74 
History of Congestive Heart Failure   25 
History of Percutaneous Coronary Intervention   85 
History of Coronary Artery Bypass Graft Surgery   54 
Stable Angina   44 
Unstable Angina   1 
No Angina   245 
[1] The same participant may be included in more than one category or not all participants may contribute to a category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Neurological/Renal History [1] 
[Units: Participants]
 
History of Transient Ischemic Attacks   21 
History of Cerebrovascular Accident   24 
History of Renal Insufficiency   31 
History of Renal Percutaneous Intervention   4 
[1] The same participant may be included in more than one category or not all participants may contribute to a category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Peripheral Vascular History [1] 
[Units: Participants]
 
History of Peripheral Vascular Surgery   27 
History of Other Peripheral Interventions   125 
History of Claudication   281 
[1] The same participant may be included in more than one category or not all participants may contribute to a category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Baseline Lesion Characteristics: Treated Limb 
[Units: Lesions]
 
Right leg   138 
Left leg   161 
Baseline Lesion Characteristics: Reference Vessel Diameter 
[Units: Millimeters]
Mean (Standard Deviation)
 5.6  (0.7) 
Baseline Lesion Characteristics: Diameter Stenosis 
[Units: Percentage occluded]
Mean (Standard Deviation)
 91.7  (9.2) 
Baseline Lesion Characteristics: Target Lesion Length 
[Units: Millimeters]
Mean (Standard Deviation)
 90.8  (44.4) 
Baseline Lesion Characteristics: Presence of Calcification 
[Units: Lesions]
 
None/Mild   88 
Moderate   103 
Severe   106 
Not Available   2 


  Outcome Measures
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1.  Primary:   Primary Safety Endpoint and Components   [ Time Frame: 1 month for death, 12 months for target limb major amputation , and target lesion revascularization ]

2.  Primary:   Co-Primary Efficacy Endpoints   [ Time Frame: 12 months ]

3.  Secondary:   Secondary Safety Endpoint and Components   [ Time Frame: 1 month ]

4.  Other Pre-specified:   Technical and Procedural Success   [ Time Frame: Up to 24 hours after the procedure ]

5.  Other Pre-specified:   Primary Patency   [ Time Frame: 12 months ]

6.  Other Pre-specified:   Assisted Primary Patency   [ Time Frame: 12 months ]

7.  Other Pre-specified:   Stent Fracture Rate   [ Time Frame: 12 months ]

8.  Other Pre-specified:   Rutherford Classification   [ Time Frame: 12 months ]

9.  Other Pre-specified:   Rate of Hemodynamic Improvement   [ Time Frame: 12 months ]

10.  Other Pre-specified:   Walking Improvement Assessed by the Walking Impairment Questionnaire   [ Time Frame: 12 months ]

11.  Other Pre-specified:   Walking Improvement (Time) Assessed by 6 Minute Hall Walk   [ Time Frame: 12 months ]

12.  Other Pre-specified:   Quality of Life   [ Time Frame: 12 months ]

13.  Other Pre-specified:   Walking Improvement (Distance) Assessed by 6 Minute Hall Walk   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director Clinical Trials
Organization: Boston Scientific Cooperation
phone: 763-494-2170
e-mail: Ana.Becker@bsci.com


Publications:

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01292928     History of Changes
Other Study ID Numbers: G100291
Study First Received: February 9, 2011
Results First Received: August 14, 2015
Last Updated: September 12, 2016
Health Authority: United States: Food and Drug Administration