N/A
N=299
SuperNOVA Clinical Stenting Trial
Atherosclerosis of Native Arteries of the Extremities, Unspecified
Bottom Line
View on ClinicalTrials.gov: NCT01292928 ↗Enrolled (actual)
299
Serious AEs
53.8%
Results posted
Jan 2016
Primary outcome: Primary: Primary Safety Endpoint and Components — 85.8; 14.2; 0.0; 0.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stent implantation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint and Components |
85.8; 14.2; 0.0; 0.4; 14.2 | — |
| PRIMARY Co-Primary Efficacy Endpoints |
69.7; 66.8 | — |
| SECONDARY Secondary Safety Endpoint and Components |
99.7; 0.3; 0.0; 0.0; 0.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects age 18 and older
- Chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4
- Stenotic, restenotic (from angioplasty only) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery:
- Degree of stenosis >/=70% by visual angiographic assessment
- Vessel diameter >/= 4 and /=30mm and 3 months prior to stent placement
- Target lesion located at least three centimeters above the inferior edge of the femur
- Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent ( 600,000 mm3
- Concomitant renal failure with a serum creatinine >2.0 mg/dL
- Receiving dialysis or immunosuppressant therapy
- Pregnancy
- Current participation in another investigational drug or device clinical study
- Known allergy to Nitinol
- Septicemia at the time of the index procedure
- Presence of other hemodynamically significant outflow lesions requiring intervention within 30 days of the index procedure
- Target lesion is within or near an aneurysm
- Acute ischemia and/or acute thrombosis of the SFA/PPA
- Persistent, intraluminal thrombus of the proposed target lesion post- thrombolytic therapy
- Perforated vessel as evidenced by extravasation of contrast media
- Heavily calcified lesions
Data sourced from ClinicalTrials.gov (NCT01292928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.