Abdominal Aortic Aneurysm (AAA)NCT02009644
Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms
A study testing Subjects who receive the Treovance stent-graft in people with Abdominal Aortic Aneurysm (AAA), run by Bolton Medical at 29 sites in United States.
Trial summary
The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Abdominal Aortic Aneurysm (AAA)
- What is being tested?
- Subjects who receive the Treovance stent-graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 29 sitesUnited States
- Study dates
- 23 Nov 2013to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be between the ages of 18 and 85
- Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement, by CT with contrast performed within 4 months of planned implant procedure
- Subject must have an infrarenal AAA that i. is > 4.5 cm in diameter for males, or > 4.0 cm in diameter for females, or ii. has increased in diameter by 0.5 cm in the last 6 months
- Subject must have i. infrarenal landing neck length of 10 mm or greater and an angle of less than 60 degrees relative to the long axis of the aneurysm (centerline at lowest renal to centerline at bifurcation) and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an outside diameter of 17 mm -32 mm, or ii. infrarenal landing neck length of 15 mm or greater and an angle of between 60 and 75 degrees relative to the long axis of the aneurysm and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an outside diameter of 16 mm-30 mm
- Subject's infrarenal landing neck must meet the vessel size requirements specified in the instructions for use (IFU) for the corresponding devices
- Subject must have lowest renal artery at least 9 cm from the aortic bifurcation
Show all 14Show fewer
- Subject must have a distal iliac landing neck with i. an inside diameter of 8 mm - 13 mm and a length of at least 10 mm, or ii. an inside diameter of >13 mm - 20 mm and a length of at least 15 mm
- Subject's distal iliac landing neck must meet the vessel size requirements specified for the corresponding devices in the IFU
- Subject must have a total treatment length of at least 13 cm
- Subject must have a distal aortic diameter above the iliac bifurcation equal to or greater than 70% of the sum of the selected leg graft diameters that will pass through the same
- Subject must be willing and able to comply with 1-month, 6-month, and 12-month follow-up visits, as well as annual visits out to 5 years
- Subject must have adequate renal function to tolerate required follow-up contrast-enhanced CTs
- Subject must have adequate vascular access (e.g., patent iliac or femoral arteries) for introduction of the Navitel Delivery System, which is 18F (6 mm) or 19F (6.3 mm) outer diameter based on size of device used. Alternatively, subject's anatomy is suitable for creation of an iliac conduit.
- Subject or Legally Authorized Representative (LAR) must agree to sign Informed Consent Form
Who cannot join
- Subject is pregnant or lactating
- Subject has a dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)
- Subject has a patent inferior mesenteric artery that cannot be sacrificed and an occluded or stenotic celiac and/or superior mesenteric artery
- Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging
- Subject has a lesion that cannot be crossed by a guide wire
- Proximal neck cannot increase by more than 10% over 15mm or more than 7% over 10mm; i.e., no trapezoidal necks
Show all 24Show fewer
- Subject has severe untreated coronary artery disease and/or unstable angina, significant areas of myocardium at risk (based on coronary angiogram or radionuclide scans), left ventricular ejection fraction < 20%, or recent diagnosis of Congestive Heart Failure (CHF)
- Subject has had a stroke or myocardial infarction within 6 months of the planned treatment date
- Subject has chronic obstructive pulmonary disease requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use)
- Subject has an active systemic infection or is suspected of having an active systemic infection (e.g.,AIDS/HIV, sepsis)
- Subject is morbidly obese (more than 100% over the ideal body weight or as defined by institutional standards) or has other clinical conditions that severely compromise or impair x-ray visualization of the aorta
- Subject has connective tissue disease (e.g., Marfan's syndrome)
- Subject has a mycotic aneurysm
- Subject has significant or circumferential calcification or mural thrombus in the proximal aortic neck
- Subject has significant or circumferential calcification or mural thrombus in the distal iliac landing zone
- Subject has significant or circumferential calcification or mural thrombus within the treatment length, which may adversely impact device patency
- Subject has a blood coagulation disorder or bleeding diathesis, the treatment for which cannot be suspended pre- and post-repair
- Subject is in acute or chronic renal failure (creatinine > 2.5 mg/dL) unless subject is stable on dialysis
- Subject has less than two-year life expectancy as evidenced by factors prohibiting major medical intervention (e.g., presence of malignancy, severe cardiopulmonary disease, etc.)
- Subject is participating in another research study, has received investigational study drug within 30 days of planned procedure, or has received an investigational device within one year of planned procedure
- Subject is confronted with other medical, social or psychological issues that the investigator believes may interfere with study treatment or follow-up. These reasons must be documented. An example may include adherence to a theological or personal doctrine with aversion or opposition to blood transfusion.
- Subject has had a prior AAA repair (endovascular or surgical)
- Subject has an untreatable allergy or sensitivity to contrast media, nitinol/nickel, or polyester
- Subject has undergone other major surgical or medical intervention within 45 days of the planned procedure or is planning to undergo other major surgical or medical intervention within 45 days post implantation (e.g., Coronary Artery Bypass Graft (CABG), organ transplantation, renal stenting, etc.)
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Community Care (previously Albany Medical Center)
Albany, New York, 12205
Mission Hospital
Asheville, North Carolina, 28801
Northside Hospital Heart & Vascular Institute
Atlanta, Georgia, 30342
University of Alabama-Birmingham
Birmingham, Alabama, 35294
Lynn Heart and Vascular Institute
Boca Raton, Florida, 33486
Tufts University Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Buffalo General Medical Center
Buffalo, New York, 14203
Presence Medical Center -- Christie Clinic
Champaign, Illinois, 61820
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
Danbury Hospital
Danbury, Connecticut, 06810
East Carolina University / Pitt County Memorial Hospital
Greenville, North Carolina, 27834
University of Iowa Hospital and Clinic
Iowa City, Iowa, 52242
Mount Sinai Medical Center
New York, New York, 10029
Sentara Vascular Specialists
Norfolk, Virginia, 23507
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140
Arizona Heart Institute
Phoenix, Arizona, 85006
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Rhode Island Hospital
Providence, Rhode Island, 02905
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester -- Strong Memorial Hospital
Rochester, New York, 14623
Affiliated Surgeons of Rockford Memorial Hospital
Rockford, Illinois, 61103
North Central Heart (Avera Heart Hospital)
Sioux Falls, South Dakota, 51108
Sanford University of South Dakota Medical Center
Sioux Falls, South Dakota, 57117
Stony Brook Medical Center
Stony Brook, New York, 11794-8191
University of Massachusetts
Worcester, Massachusetts, 01655
York Hospital
York, Pennsylvania, 17403
About this study
Official title: A Phase II Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).
Read the detailed description
This is a phase II, multi-center, non-blinded, non-randomized study of treatment with the Treovance Stent-Graft in subjects with abdominal aortic aneurysms. The study will include 150 subjects treated with the Treovance Stent-Graft at a maximum of 30 investigational sites. Upon completion of enrollment of150 subjects, an additional 50 subjects may be treated with the Treovance Stent-Graft at the 30 investigative sites participating in the trial. These additional subjects will follow the same study schedule, and data from these patients may be used to supplement the pivotal trial data. There will be no prospective control group. Subjects diagnosed with infrarenal abdominal aortic aneurysms enrolled in the trial will be treated with the Treovance Stent-Graft with Navitel Delivery System. Pre-procedure baseline data will be gathered, as well as post-procedure assessments prior to hospital discharge and 30 days, 6 months, and 12 months post-implantation. In addition, annual follow-up visits out to 5 years will be conducted. Subjects with fracture(s) confirmed by the Core Lab within the first 5 years will be followed for an additional 5 years, for a total of 10 years post-implantation.
The primary goal of this study is to gather safety and effectiveness data on the Treovance device. A maximum of 150 endovascular subjects will be required to fulfill the U.S. Phase II requirements. The data from this study will be submitted to the FDA and used to support approval in the U.S.
There are two primary objectives, efficacy and safety of the Treovance Stent-Graft in subjects with infrarenal aortic aneurysms:
- Primary Efficacy will be evaluated by successful aneurysm treatment 12 months post-implant
- Primary Safety will be assessed by composite major adverse event (MAE) rate at 30-days
Secondary objectives involve assessment of major device-related events and major morbidity.
- Conditions
- Abdominal Aortic Aneurysm (AAA)
- Being tested
- Subjects who receive the Treovance stent-graft
- Keywords
- Abdominal Aortic Aneurysm, AAA, Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjects who receive the Treovance stent-graftDevice
Also called Treovance Abdominal Stent-Graft with Navitel Delivery System
Eligible subjects will be implanted with the Treovance Stent-Graft
| Study group | Role | What they receive |
|---|---|---|
| Treovance | Experimental | Subjects who receive the Treovance stent-graft Receives: Device: Subjects who receive the Treovance stent-graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy
Successful aneurysm treatment which is a composite of the following: Technical success at the conclusion of the procedure; absence of aneurysm enlargement; absence of device-related complications (e.g., fracture, conversion to open surgical repair, etc.)
Measured: 12 months
Primary Safety
The primary safety endpoint is composite major adverse event (MAE) rate (including myocardial infarction, stroke, respiratory failure, etc.)
Measured: 30 days
Secondary outcomes (7)
Secondary Efficancy Endpoint -- Aneurysm-Related Mortality
Aneurysm-related mortality at 12 month and annually to 5 years; annually to 10 years for subjects with Core Lab-confirmed fracture(s)
Measured: Annually to 5-years; annually to 10-years (stent-fracture subjects only)
Secondary Efficacy Endpoint -- Technical Success
Technical success at 30 days confirmed by an imaging modality (e.g. CT)
Measured: 30 days
Secondary Efficacy Endpoint -- Clinical Utility Measures
Clinical utility measures (procedure time, time in the intensive care unit, length of hospital stay)
Measured: Perioperative/Periprocedural
Secondary Efficacy Endpoint -- Secondary interventions
The secondary efficacy endpoint includes the rate of additional procedures performed to correct the original implant
Measured: 30 days, 6 months, annually to 5-years; annually to 10-years (stent-fracture subjects only)
Secondary Efficacy Endpoint -- Device-Related Events
This endpoint includes the rate of events associated with the device.
Measured: 30 days, 6 months, and annually to 5-years; annually to 10-years (stent-fracture subjects only)
Secondary Safety Endpoint -- Individual Rate for Events included in the composite MAE
Secondary safety endpoints will include each individual rate for the adverse events included in the composite MAE at 30 days, 6 months, and annually to 5 years
Measured: 30 days, 6 months, annually to 5 years
Secondary Safety Endpoint -- Procedure-Related Complications
Procedure-related complications at 30 days, 6 months, 12 months, and annually to 5 years.
Measured: 30 days, 6 months, annually to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study start23 Nov 2013
- Primary completion20 Mar 2017
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic Aneurysm (AAA)Studies of the same condition, open and under way.
- 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
- Model description
- AAA Device
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bolton Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Eagleton, MD, Principal investigator, Cleveland Clinic Foundaton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009644
- Sponsor's protocol ID
- IP-0008-12
- Status last verified
- Jun 2025
- First submitted
- 6 Nov 2013
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Eagleton MJ, Stoner MC, Henretta J, Dryjski M, Panneton JM, Tassiopoulos A, Mehta M, Pearce B, Sharafuddin MJ; TREO Investigators. Long-term safety and effectiveness of the TREO stent graft for the endovascular treatment of infrarenal abdominal aortic aneurysms. J Vasc Surg. 2026 Jan;83(1):50-56. doi: 10.1016/j.jvs.2025.08.032. Epub 2025 Aug 29.
PubMed 40886742
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT02009644
- Acronym / sponsor ID
- IP-0008-12
- Conditions
- Abdominal Aortic Aneurysm (AAA)
- Keywords
- Abdominal Aortic Aneurysm, AAA, Aneurysm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Bolton MedicalIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2013 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).
Detailed description
This is a phase II, multi-center, non-blinded, non-randomized study of treatment with the Treovance Stent-Graft in subjects with abdominal aortic aneurysms. The study will include 150 subjects treated with the Treovance Stent-Graft at a maximum of 30 investigational sites. Upon completion of enrollment of150 subjects, an additional 50 subjects may be treated with the Treovance Stent-Graft at the 30 investigative sites participating in the trial. These additional subjects will follow the same study schedule, and data from these patients may be used to supplement the pivotal trial data. There will be no prospective control group. Subjects diagnosed with infrarenal abdominal aortic aneurysms enrolled in the trial will be treated with the Treovance Stent-Graft with Navitel Delivery System. Pre-procedure baseline data will be gathered, as well as post-procedure assessments prior to hospital discharge and 30 days, 6 months, and 12 months post-implantation. In addition, annual follow-up visits out to 5 years will be conducted. Subjects with fracture(s) confirmed by the Core Lab within the first 5 years will be followed for an additional 5 years, for a total of 10 years post-implantation.
The primary goal of this study is to gather safety and effectiveness data on the Treovance device. A maximum of 150 endovascular subjects will be required to fulfill the U.S. Phase II requirements. The data from this study will be submitted to the FDA and used to support approval in the U.S.
There are two primary objectives, efficacy and safety of the Treovance Stent-Graft in subjects with infrarenal aortic aneurysms:
- Primary Efficacy will be evaluated by successful aneurysm treatment 12 months post-implant
- Primary Safety will be assessed by composite major adverse event (MAE) rate at 30-days
Secondary objectives involve assessment of major device-related events and major morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- AAA Device
| Arm | Type | Receives |
|---|---|---|
| Treovance | Experimental | Device: Subjects who receive the Treovance stent-graftSubjects who receive the Treovance stent-graft |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject must be between the ages of 18 and 85
- Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement, by CT with contrast performed within 4 months of planned implant procedure
- Subject must have an infrarenal AAA that i. is > 4.5 cm in diameter for males, or > 4.0 cm in diameter for females, or ii. has increased in diameter by 0.5 cm in the last 6 months
- Subject must have i. infrarenal landing neck length of 10 mm or greater and an angle of less than 60 degrees relative to the long axis of the aneurysm (centerline at lowest renal to centerline at bifurcation) and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an outside diameter of 17 mm -32 mm, or ii. infrarenal landing neck length of 15 mm or greater and an angle of between 60 and 75 degrees relative to the long axis of the aneurysm and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an outside diameter of 16 mm-30 mm
- Subject's infrarenal landing neck must meet the vessel size requirements specified in the instructions for use (IFU) for the corresponding devices
Key exclusion criteria (24 listed)
- Subject is pregnant or lactating
- Subject has a dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)
- Subject has a patent inferior mesenteric artery that cannot be sacrificed and an occluded or stenotic celiac and/or superior mesenteric artery
- Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging
- Subject has a lesion that cannot be crossed by a guide wire
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 |
|---|---|---|
| Subjects who receive the Treovance stent-graftAlso: Treovance Abdominal Stent-Graft with Navitel Delivery SystemEligible subjects will be implanted with the Treovance Stent-Graft | Device | Treovance |
Primary outcome
Primary Efficacy
Time frame: 12 months
Successful aneurysm treatment which is a composite of the following: Technical success at the conclusion of the procedure; absence of aneurysm enlargement; absence of device-related complications (e.g., fracture, conversion to open surgical repair, etc.)
Primary Safety
Time frame: 30 days
The primary safety endpoint is composite major adverse event (MAE) rate (including myocardial infarction, stroke, respiratory failure, etc.)
7 secondary outcomes
Secondary Efficancy Endpoint -- Aneurysm-Related Mortality
Time frame: Annually to 5-years; annually to 10-years (stent-fracture subjects only)
Secondary Efficacy Endpoint -- Technical Success
Time frame: 30 days
Secondary Efficacy Endpoint -- Clinical Utility Measures
Time frame: Perioperative/Periprocedural
Secondary Efficacy Endpoint -- Secondary interventions
Time frame: 30 days, 6 months, annually to 5-years; annually to 10-years (stent-fracture subjects only)
Secondary Efficacy Endpoint -- Device-Related Events
Time frame: 30 days, 6 months, and annually to 5-years; annually to 10-years (stent-fracture subjects only)
Secondary Safety Endpoint -- Individual Rate for Events included in the composite MAE
Time frame: 30 days, 6 months, annually to 5 years
Secondary Safety Endpoint -- Procedure-Related Complications
Time frame: 30 days, 6 months, annually to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Derived from this study: PubMed 40886742Eagleton MJ, Stoner MC, Henretta J, Dryjski M, Panneton JM, Tassiopoulos A, Mehta M, Pearce B, Sharafuddin MJ; TREO Investigators. Long-term safety and effectiveness of the TREO stent graft for the endovascular treatment of infrarenal abdominal aortic aneurysms. J Vasc Surg. 2026 Jan;83(1):50-56. doi: 10.1016/j.jvs.2025.08.032. Epub 2025 Aug 29.
- Individual participant dataSharing planned: No
Related trials for Abdominal Aortic Aneurysm (AAA)
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
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.
Matthew Eagleton, MD principal investigator
Cleveland Clinic Foundaton
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subjects who receive the Treovance stent-graft in people with Abdominal Aortic Aneurysm (AAA), run by Bolton Medical at 29 sites in United States.
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 14 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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 Efficacy (time frame: 12 months). 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 NCT02009644, 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 28 Jan 2026.