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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00916370




Registration number
NCT00916370
Ethics application status
Date submitted
5/06/2009
Date registered
9/06/2009
Date last updated
8/06/2015

Titles & IDs
Public title
SPIRIT PRIME Clinical Trial
Scientific title
SPIRIT PRIME Clinical Trial.
Secondary ID [1] 0 0
06-373
Universal Trial Number (UTN)
Trial acronym
SPIRIT PRIME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Ischemia 0 0
Coronary Artery Stenosis 0 0
Coronary Disease 0 0
Coronary Artery Disease 0 0
Coronary Restenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Core size Xience Prime
Treatment: Devices - Xience Prime Long Lesion (LL)

Experimental: Core size registry (CSR) - Core size indicates the range of diameters of the stents used.

Experimental: Long lesion registry (LLR) - Use of long lesion stents.


Treatment: Devices: Core size Xience Prime
Core size includes a range of stent sizes.

Treatment: Devices: Xience Prime Long Lesion (LL)
Long lesion stent sizes include a range of sizes.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Target Lesion Failure (TLF)
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Target Lesion Failure (TLF)
Timepoint [2] 0 0
2 years
Primary outcome [3] 0 0
Target Lesion Failure (TLF)
Timepoint [3] 0 0
3 years
Secondary outcome [1] 0 0
Procedure Time
Timepoint [1] 0 0
From insertion to withdrawal of guide catheter
Secondary outcome [2] 0 0
Device Success (Lesion Basis)
Timepoint [2] 0 0
From the start of index procedure to end of index procedure
Secondary outcome [3] 0 0
Procedural Success (Subject Basis)
Timepoint [3] 0 0
From the start of index procedure to end of index procedure
Secondary outcome [4] 0 0
All Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [4] 0 0
In-hospital is less than or equal to 7 days post index procedure
Secondary outcome [5] 0 0
All Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [5] 0 0
30 days
Secondary outcome [6] 0 0
All Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [6] 0 0
180 days
Secondary outcome [7] 0 0
All Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
All Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
All Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [9] 0 0
3 years
Secondary outcome [10] 0 0
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Timepoint [10] 0 0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.
Secondary outcome [11] 0 0
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Timepoint [11] 0 0
30 days
Secondary outcome [12] 0 0
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Timepoint [12] 0 0
180 days
Secondary outcome [13] 0 0
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Timepoint [13] 0 0
1 year
Secondary outcome [14] 0 0
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Timepoint [14] 0 0
2 years
Secondary outcome [15] 0 0
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Timepoint [15] 0 0
3 years
Secondary outcome [16] 0 0
Non-target Vessel MI (Q-wave, Non Q-wave)
Timepoint [16] 0 0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Secondary outcome [17] 0 0
Non-target Vessel MI (Q-wave, Non Q-wave)
Timepoint [17] 0 0
30 days
Secondary outcome [18] 0 0
Non-target Vessel MI (Q-wave, Non Q-wave)
Timepoint [18] 0 0
180 days
Secondary outcome [19] 0 0
Non-target Vessel MI (Q-wave, Non Q-wave)
Timepoint [19] 0 0
1 year
Secondary outcome [20] 0 0
Non-target Vessel MI (Q-wave, Non Q-wave)
Timepoint [20] 0 0
2 years
Secondary outcome [21] 0 0
Non-target Vessel MI (Q-wave, Non Q-wave)
Timepoint [21] 0 0
3 years
Secondary outcome [22] 0 0
Clinically Indicated-Target Lesion Revascularization
Timepoint [22] 0 0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Secondary outcome [23] 0 0
Clinically Indicated-Target Lesion Revascularization
Timepoint [23] 0 0
30 days
Secondary outcome [24] 0 0
Clinically Indicated-Target Lesion Revascularization
Timepoint [24] 0 0
180 days
Secondary outcome [25] 0 0
Clinically Indicated-Target Lesion Revascularization
Timepoint [25] 0 0
1 year
Secondary outcome [26] 0 0
Clinically Indicated-Target Lesion Revascularization
Timepoint [26] 0 0
2 years
Secondary outcome [27] 0 0
Clinically Indicated-Target Lesion Revascularization
Timepoint [27] 0 0
3 years
Secondary outcome [28] 0 0
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Timepoint [28] 0 0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Secondary outcome [29] 0 0
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Timepoint [29] 0 0
30 days
Secondary outcome [30] 0 0
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Timepoint [30] 0 0
180 days
Secondary outcome [31] 0 0
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Timepoint [31] 0 0
1 year
Secondary outcome [32] 0 0
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Timepoint [32] 0 0
2 years
Secondary outcome [33] 0 0
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Timepoint [33] 0 0
3 years
Secondary outcome [34] 0 0
All TLR (CI and Non-CI)
Timepoint [34] 0 0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Secondary outcome [35] 0 0
All TLR (CI and Non-CI)
Timepoint [35] 0 0
30 days
Secondary outcome [36] 0 0
All TLR (CI and Non-CI)
Timepoint [36] 0 0
180 days
Secondary outcome [37] 0 0
All TLR (CI and Non-CI)
Timepoint [37] 0 0
1 year
Secondary outcome [38] 0 0
All TLR (CI and Non-CI)
Timepoint [38] 0 0
2 years
Secondary outcome [39] 0 0
All TLR (CI and Non-CI)
Timepoint [39] 0 0
3 years
Secondary outcome [40] 0 0
All TVR (CI and Non-CI)
Timepoint [40] 0 0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Secondary outcome [41] 0 0
All TVR (CI and Non-CI)
Timepoint [41] 0 0
30 days
Secondary outcome [42] 0 0
All TVR (CI and Non-CI)
Timepoint [42] 0 0
180 days
Secondary outcome [43] 0 0
All TVR (CI and Non-CI)
Timepoint [43] 0 0
1 year
Secondary outcome [44] 0 0
All TVR (CI and Non-CI)
Timepoint [44] 0 0
2 years
Secondary outcome [45] 0 0
All TVR (CI and Non-CI)
Timepoint [45] 0 0
3 years
Secondary outcome [46] 0 0
All Coronary Revascularization (TVR and Non-TVR)
Timepoint [46] 0 0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Secondary outcome [47] 0 0
All Coronary Revascularization (TVR and Non-TVR)
Timepoint [47] 0 0
30 days
Secondary outcome [48] 0 0
All Coronary Revascularization (TVR and Non-TVR)
Timepoint [48] 0 0
180 days
Secondary outcome [49] 0 0
All Coronary Revascularization (TVR and Non-TVR)
Timepoint [49] 0 0
1 year
Secondary outcome [50] 0 0
All Coronary Revascularization (TVR and Non-TVR)
Timepoint [50] 0 0
2 years
Secondary outcome [51] 0 0
All Coronary Revascularization (TVR and Non-TVR)
Timepoint [51] 0 0
3 years
Secondary outcome [52] 0 0
Cardiac Death/All MI
Timepoint [52] 0 0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Secondary outcome [53] 0 0
Cardiac Death/ All MI
Timepoint [53] 0 0
30 days
Secondary outcome [54] 0 0
Cardiac Death/All MI
Timepoint [54] 0 0
180 days
Secondary outcome [55] 0 0
Cardiac Death/All MI
Timepoint [55] 0 0
1 year
Secondary outcome [56] 0 0
Cardiac Death/All MI
Timepoint [56] 0 0
2 years
Secondary outcome [57] 0 0
Cardiac Death/All MI
Timepoint [57] 0 0
3 years
Secondary outcome [58] 0 0
Cardiac Death/ All MI/CI-TLR
Timepoint [58] 0 0
in-hospital
Secondary outcome [59] 0 0
Cardiac Death/ All MI/CI-TLR
Timepoint [59] 0 0
30 days
Secondary outcome [60] 0 0
Cardiac Death/ All MI/CI-TLR
Timepoint [60] 0 0
180 days
Secondary outcome [61] 0 0
Cardiac Death/ All MI/CI-TLR
Timepoint [61] 0 0
1 year
Secondary outcome [62] 0 0
Cardiac Death/ All MI/CI-TLR
Timepoint [62] 0 0
2 years
Secondary outcome [63] 0 0
Cardiac Death/ All MI/CI-TLR
Timepoint [63] 0 0
3 years
Secondary outcome [64] 0 0
All Death/All MI/All Coronary Revascularization
Timepoint [64] 0 0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Secondary outcome [65] 0 0
All Death/All MI/All Coronary Revascularization
Timepoint [65] 0 0
30 days
Secondary outcome [66] 0 0
All Death/All MI/All Coronary Revascularization
Timepoint [66] 0 0
180 days
Secondary outcome [67] 0 0
All Death/All MI/All Coronary Revascularization
Timepoint [67] 0 0
1 year
Secondary outcome [68] 0 0
All Death/All MI/All Coronary Revascularization
Timepoint [68] 0 0
2 years
Secondary outcome [69] 0 0
All Death/All MI/All Coronary Revascularization
Timepoint [69] 0 0
3 years
Secondary outcome [70] 0 0
Stent Thrombosis
Timepoint [70] 0 0
Acute (=1 day)
Secondary outcome [71] 0 0
Stent Thrombosis
Timepoint [71] 0 0
Subacute (>1 - 30 days)
Secondary outcome [72] 0 0
Stent Thrombosis
Timepoint [72] 0 0
Acute/Subacute (0 - 30 days)
Secondary outcome [73] 0 0
Stent Thrombosis
Timepoint [73] 0 0
Late (31 - 393 days)
Secondary outcome [74] 0 0
Stent Thrombosis
Timepoint [74] 0 0
Late (31 - 758 days)
Secondary outcome [75] 0 0
Stent Thrombosis
Timepoint [75] 0 0
Very Late (394 - 758 days)
Secondary outcome [76] 0 0
Stent Thrombosis
Timepoint [76] 0 0
Late (31 - 1123 days)
Secondary outcome [77] 0 0
Stent Thrombosis
Timepoint [77] 0 0
Very Late (394 - 1123 days)
Secondary outcome [78] 0 0
Stent Thrombosis
Timepoint [78] 0 0
Overall (0-393 days)
Secondary outcome [79] 0 0
Stent Thrombosis
Timepoint [79] 0 0
Overall (0-758 days)
Secondary outcome [80] 0 0
Stent Thrombosis
Timepoint [80] 0 0
Overall (0-758 days)
Secondary outcome [81] 0 0
Stent Thrombosis
Timepoint [81] 0 0
Overall (0 - 1123 days)
Secondary outcome [82] 0 0
Stent Thrombosis
Timepoint [82] 0 0
Overall (0 - 1123 days)

Eligibility
Key inclusion criteria
1. Subject must be at least 18 years of age.
2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
3. Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
5. Subject must agree to undergo all protocol-required follow-up procedures.
6. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

1. One or two de novo target lesions each in a different epicardial vessel.
2. If there are two target lesions, both lesions must satisfy the angiographic eligibility criteria for that registry.

o Multiple focal de novo lesions in a target vessel that can be covered by a single stent are allowed.
3. The target lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of = 50% and < 100% with a TIMI flow of = 1.
4. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of:

* = 2.25 mm and = 4.25 mm for treatment by the core size XIENCE PRIME EECS
* = 2.5 mm and = 4.25 mm for treatment by the XIENCE PRIME LL EECS
5. Target lesion(s) must be located in a native coronary artery with length by visual estimation of:

* = 22 mm for treatment by the core size XIENCE PRIME EECS
* > 22 mm and = 32 mm for treatment by the XIENCE PRIME LL EECS
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB = 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure.
2. The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
3. Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
4. Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
5. Subject has received coronary brachytherapy in any epicardial vessel (target or non target).
6. Subject has received any organ transplant or is on a waiting list for any organ transplant.
7. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
8. Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.
9. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).
10. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
11. Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.
12. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
13. Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel.
14. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
15. Subject has known renal insufficiency (examples being but not limited to estimated glomerular filtration rate (eGFR) < 60 ml/kg/m2, serum creatinine level = 2.5 mg/dL, or on dialysis).
16. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
17. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
18. Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.
19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
20. Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
21. Subject is currently participating in another clinical study that has not yet completed its primary endpoint.
22. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.

1. Target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or saphenous vein graft.
2. Target lesion involving a bifurcation with a side branch = 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guide wire, or side branch requiring dilatation.
3. Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.
4. Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion.
5. Restenotic target lesion.
6. Aorto-ostial target lesion (within 3 mm of the aorta junction).
7. Target lesion is in a left main location.
8. Target lesion located within 2 mm of the origin of the LAD or LCX.
9. Extreme angulation (= 90 °) or excessive tortuosity (= two 45° angles) proximal to or within the lesion.
10. Heavy calcification proximal to or within the target lesion.
11. Target vessel contains thrombus as indicated in the angiographic images.
12. Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon).
13. Target vessel is previously treated with any type of PCI (e.g. balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure.
14. Non-target vessel is previously treated with any type of PCI < 90 days prior to the index procedure.
15. Additional clinically significant lesion(s) (e.g. %DS = 50%) in a target vessel or side branch for which PCI may be required < 90 days after the index procedure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
Accrual to date
Final
525
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Wesley Hospital - Auchenflower
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
Monash Heart - Clayton
Recruitment hospital [4] 0 0
St. Vincent's Hospital - Melbourne
Recruitment hospital [5] 0 0
Epworth Hospital - Richmond
Recruitment hospital [6] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Auchenflower
Recruitment postcode(s) [2] 0 0
4061 - Chermside
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3065 - Melbourne
Recruitment postcode(s) [5] 0 0
3121 - Richmond
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Montana
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Oregon
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
South Dakota
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Vermont
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
United States of America
State/province [31] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marco Costa, MD, PhD
Address 0 0
University Hospitals Cleveland Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00916370