Atherosclerosis of Native Arteries of the Extremities, UnspecifiedNCT01292928
SuperNOVA Clinical Stenting Trial
A study testing Stent implantation in people with Atherosclerosis of Native Arteries of the Extremities, Unspecified, run by Boston Scientific Corporation at 49 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis of Native Arteries of the Extremities, Unspecified
- What is being tested?
- Stent implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 49 sitesin 7 countries
- Study dates
- Apr 2011to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 </= 7mm
- Total lesion length (or series of lesions) >/=30mm and </= 190 mm (note: tandem lesions may be treated, provided that the tandem lesion segment can be covered with only one stent)
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- If lesion is restenotic, PTA treatment must be >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 (<50% stenosis) to the ankle or foot
- Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits
Who cannot join
- Previous stent placement in the target vessel
- Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease
- Subjects who have undergone prior percutaneous transluminal angioplasty (PTA) in the target SFA/PPA in the past 3 months
- Use of atherectomy devices or other adjunctive treatment in the SFA/PPA during the index procedure
- History of major amputation in the same limb as the target lesion
- Life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical study, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical study
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- Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
- Intolerance to antiplatelet, anticoagulant, or thrombolytic medications
- Platelet count <150,000 mm3 or >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
Trial locations and contacts
49 sites in 7 countries.
49 sites in 7 countries
United States28 sites
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342
Frederick Memorial Hospital
Baltimore, Maryland, 21287
Medical Center East
Birminham, Alabama, 25235
Willis Knighton Bossier Medical Center
Bossier City, Louisiana, 71111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 05115
Fletcher Allen Health Care
Burlington, Vermont, 05401
Mid-Carolina Cardiology Presbyterian Hospital
Charlotte, North Carolina, 28204
Ohio State University Medical Center
Columbus, Ohio, 43210
Grant Medical Center
Columbus, Ohio, 43215
VA North Texas Health Care System
Dallas, Texas, 75216
Parkview Hospital
Fort Wayne, Indiana, 46805
Heart Center of Northe Texas
Fort Worth, Texas, 76104
University of Texas Medical Branch
Galveston, Texas, 77555
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
St. Joseph's Hospital Health Center
Liverpool, New York, 13203
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Methodist North Hospital
Memphis, Tennessee, 35128
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
St. Thomas Research Institute, LLC
Nashville, Tennessee, 37205
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
St. Francis Medical Center
Peoria, Illinois, 61614
Northern Michigan Hospital
Petoskey, Michigan, 49770
UPMC - Passavant
Pittsburgh, Pennsylvania, 15213
Rex Hospital
Raliegh, North Carolina, 27607
Swedish Medical Center
Seattle, Washington, 98122
Coastal Surgery Specialists
Wilmington, North Carolina, 28401
York Hospital
York, Pennsylvania, 17405
Japan6 sites
Kansai Rosai Hospital
Amagasaki-shi, Hyōgo, 660-8511
Kishiwada Tokushukai Hospital
Kishiwada-shi, Osaka, 596-8522
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, 802-8055
Morinomiya Hospital
Osaka, 536-0025
Tokeidai Memorial Hospital
Sapporo, Hokkaido, 060-0031
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666
Belgium5 sites
Imelda Ziekenhuis
Bonheiden, 2820
AZ Sint-Blasius, Campus Dendermonde
Dendermonde, 9200
Ziekenhuis Oost Limburg
Genk, 3600
Universitair Ziekenhuis Gent
Ghent, 9000
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, 3300
Canada4 sites
Guelph General Hospital
Guelph, N1E 6L9
Hospital Maisonneuve-Rosemont
Montreal, H1T 2M4
Fleurimont Hospital
Sherbrook, Quebec, J1H 5N4
Winnipeg Health Sciences Centre
Winnipeg, R3A 1R9
Germany4 sites
Center or Diagnostic Radiology and Minimally Invasive Therapy / Gefäßzentrum am JuedischenKrankenhaus
Berlin, 13347
Ev. Luth. Diakonissenanstalt Flensburg
Flensburg, 24939
Herzzentrum Leipzig GmbH/Park Krankenhaus
Leipzig, 04289
Friedrich-Ebert-Krankenhaus Neumuenster GmbH
Neumünster, 24534
About this study
Official title: Stenting of the Superficial Femoral (SFA) and Proximal Popliteal Arteries (PPA) With the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System
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.
Read the 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.
- Being tested
- Stent implantation
- Keywords
- Atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), lower extremities, Stenting
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent implantationDevice
Stent implantation during the index procedure.
| Study group | Role | What they receive |
|---|---|---|
| Stent | Experimental | Stent implantation into SFA/PPA Receives: Device: Stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint and Components
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
Measured: 1 month for death, 12 months for target limb major amputation , and target lesion revascularization
Co-Primary Efficacy Endpoints
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).
Measured: 12 months
Secondary outcomes (1)
Secondary Safety Endpoint and Components
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2014
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atherosclerosis of Native Arteries of the Extremities, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard J Powell, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292928
- Sponsor's protocol ID
- G100291
- Status last verified
- Jan 2017
- First submitted
- 9 Feb 2011
- Last updated
- 8 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. doi: 10.1002/ccd.21104.
PubMed 17377972
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stenting of the Superficial Femoral (SFA) and Proximal Popliteal Arteries (PPA) With the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System
- ClinicalTrials.gov ID
- NCT01292928
- Acronym / sponsor ID
- G100291
- Keywords
- Atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), lower extremities, Stenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Posted 20 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stent | Experimental | Device: Stent implantationStent implantation into SFA/PPA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot
- Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits
Key exclusion criteria (21 listed)
- Previous stent placement in the target vessel
- Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease
- Subjects who have undergone prior percutaneous transluminal angioplasty (PTA) in the target SFA/PPA in the past 3 months
- Use of atherectomy devices or other adjunctive treatment in the SFA/PPA during the index procedure
- History of major amputation in the same limb as the target lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent implantationStent implantation during the index procedure. | Device | Stent |
Primary outcome
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).
1 secondary outcome
Secondary Safety Endpoint and Components
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17377972Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. doi: 10.1002/ccd.21104.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J Powell, MD principal investigator
Dartmouth-Hitchcock Medical Center
49 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent implantation in people with Atherosclerosis of Native Arteries of the Extremities, Unspecified, run by Boston Scientific Corporation at 49 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Japan, Belgium, Canada, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint and Components (time frame: 1 month for death, 12 months for target limb major amputation , and target lesion revascularization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01292928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.