Coronary Artery DiseaseOCTDESINCT00776204
The Optical Coherence Tomography Drug Eluting Stent Investigation
A study testing JACTAX Drug eluting stent, JACTAX LD drug eluting stent and Taxus Libertè in people with Coronary Artery Disease, run by Boston Scientific Corporation at 1 site in Italy.
Trial summary
The objective of this study is to evaluate the completeness of struts coverage and vessel wall response to the new generation JACTAX drug-eluting stent vs Taxus stent in de novo coronary artery lesions at 6 months post index procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- JACTAX Drug eluting stent, JACTAX LD drug eluting stent and Taxus Libertè
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- May 2008to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- General Inclusion Criteria
- Patient is ≥ 18 years of age
- Patient is eligible for percutaneous coronary intervention (PCI)
- Patient demonstrates a left ventricular ejection fraction (LVEF) of ≥ 25%
- Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect.
- Angiographic Inclusion Criteria
- Target lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated) ≤ 25 mm that can be treated with a single JACTAX, JACTAX LD or TAXUS stent
- A second lesion in a second vessel may be treated with one (1) TAXUS™ Libertè™ DES or a bare metal stent.
Who cannot join
- General Exclusion Criteria
- The patient has a life expectancy of less than 24 months due to another medical condition
- Patient has a history of hypersensitivity to paclitaxel or structurally related compounds
- Patient exhibits cardiogenic shock (systolic pressure < 80mm Hg and PCWP > 20mm Hg or cardiac index <1.8 liters/minute/m2 or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure>80 mm Hg) for any time within 24 hours prior to index procedure
- Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine > 2.0 mg/dl or177 µmol/l)
- Planned cardiac surgery procedure ≤ 6 months post-index procedure
Show all 31Show fewer
- Patient demonstrates evidence of a acute myocardial infarction (eg. STEMI or enzyme elevation CK > 2X local laboratory's ULN unless CK-MB is < 2X ULN) 7) Cerebrovascular accident (CVA) including stroke or TIA within previous 3 months
- Patient demonstrates evidence of leukopenia (leukocyte count < 3.5 X 109/liter)
- Patient demonstrates evidence of thrombocytopenia (platelet count < 100,000/mm3) or thrombocytosis (>750,000/mm3)
- Patient is contraindicated to ASA (successful prior desensitization to ASA is not an exclusion), clopidogrel, or ticlopidine
- Patient is currently on warfarin, or possibility of treatment with warfarin during the following 6 months post index procedure
- Patient has been treated with paclitaxel or other chemotherapeutic agents within 12-months prior to planned index procedure
- Anticipated treatment with paclitaxel or oral rapamycin during any period in the 6-months after the index procedure
- Patient has received a drug eluting stent within 12-months prior to planned index procedure
- Previous or planned treatment with intravascular brachytherapy in target vessel
- Known allergy to stainless steel
- Female or male with known intention to procreate within 3 months after the index procedure (due to the exposure to paclitaxel and unknown affect it may have on the fetus)
- Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 9 months post index procedure
- Patient that in the opinion of the investigator is not clinically appropriate for OCT evaluation.
- Angiographic Exclusion Criteria
- Evidence of thrombus of the study vessel, based on angiography or IVUS
- Study lesion is totally occluded (TIMI flow ≤ 1) either at baseline or before pre-dilatation
- Study lesion, or the study vessel proximal to the study lesion is moderately or severely calcified, by visual estimate
- Study lesion is ostial in location (within 3.0 mm of vessel origin)
- Study lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a >60 degree bend in the vessel
- Study lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel > 2.0 mm in diameter
- Left main coronary artery disease (stenosis >50%) whether protected or unprotected
- Target lesion length > 25 mm, based on visual estimate by operator
- Target vessel diameter > 3.5 mm, based on visual estimate by operator
- Target vessel diameter < 2.75 mm based on visual estimate by operator
- Pre-treatment of the target lesion (excluding predilation) with another interventional device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Optical Coherence Tomography Drug Eluting Stent Investigation(OCTDESI)
The objective of this study is to evaluate the completeness of struts coverage and vessel wall response to the new generation JACTAX drug-eluting stent vs Taxus stent in de novo coronary artery lesions at 6 months post index procedure. To investigate the completeness of the coverage as well as the number of uncovered stent struts per section, high resolution (~ 10-15 µm axial) intracoronary Optical Coherence Tomography (OCT) will be used.
Read the detailed description
The risk of late stent thrombosis represents a major concern for patients treated with first generation drug-eluting stents (DES). Delayed healing and poor endothelialization are common findings in vessels treated with DES and are probably related to the amount of drug and polymer applied to a DES. There is evidence to suggest that polymer applications may influence the processes of inflammation and vessel healing. The JACTAX family of DES have been designed to provide a maximum amount of drug delivered directly to coronary vessel tissue while excluding polymer and drug from contact within the vessel lumen. The JACTAX stents are comprised of a currently marketed bare metal stent (Libertè™) coated exclusively on the ablumenal stent surface with a carrier containing a bioerodable polymer, Polylactide and paclitaxel. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the JACTAX stents vs Taxus Libertè in de novo coronary artery lesions at 6 months post index procedure. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at 6 months follow-up. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and at 6 months follow-up.
- Conditions
- Coronary Artery Disease
- Being tested
- JACTAX Drug eluting stent, JACTAX LD drug eluting stent, Taxus Libertè
- Keywords
- Coronary Artery Disease, Drug eluting stent, Percutaneous Coronary Interventions, Optical Coherence Tomography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JACTAX Drug eluting stentDevice
Also called JACTAX Drug eluting stent (Labcoat Ltd, Galway, Ireland)
Jactax stent placed in coronary artery
JACTAX LD drug eluting stentDevice
Also called JACTAX LD Drug eluting stent (Labcoat Ltd, Galway, Ireland)
JACTAX LD stent placed in coronary artery
Taxus LibertèDevice
Also called Taxus Libertè (Boston Scientific, Natick, MA)
Taxus Libertè stent placed in coronary artery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Drug Eluting Stent Receives: Device: JACTAX Drug eluting stent |
| 2 | Active comparator | Drug Eluting Stent Receives: Device: JACTAX LD drug eluting stent |
| 3 | Active comparator | Drug Eluting Stent Receives: Device: Taxus Libertè |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of stent struts uncovered and/or malapposed at OCT
Measured: 6 months
Secondary outcomes (6)
Major Adverse Cardiac Events (MACE)
Measured: 12 and 24 months
Stent Thrombosis
Measured: 12 and 24 months
Target Lesion Revascularization
Measured: 12 and 24 months
Procedural success
Measured: through discharge
QCA parameters: mean lumen diameter, acute gain, late loss and binary restenosis (≥ 50% diameter stenosis) rate
Measured: 6 months
IVUS parameters: neointimal area volume, stent and area volumes, stent apposition, and percent net volume obstruction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2009
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Labcoat, Ltd.
- Responsible party
- Sponsor
- Investigators
- Giulio Guagliumi, MD, Principal investigator, Cardiovascular Department Ospedali Riuniti di Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776204
- Sponsor's protocol ID
- LBCT-H03-07
- Acronym
- OCTDESI
- Status last verified
- Feb 2017
- First submitted
- 20 Oct 2008
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Luscher TF, Steffel J, Eberli FR, Joner M, Nakazawa G, Tanner FC, Virmani R. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation. 2007 Feb 27;115(8):1051-8. doi: 10.1161/CIRCULATIONAHA.106.675934.
PubMed 17325255Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.
PubMed 17438147Kang WC, Han SH, Choi KR, Ahn TH, Shin EK. Acute myocardial infarction caused by late stent thrombosis after deployment of a paclitaxel-eluting stent. J Invasive Cardiol. 2005 Jul;17(7):378-80. No abstract available.
PubMed 16003026Virmani R, Liistro F, Stankovic G, Di Mario C, Montorfano M, Farb A, Kolodgie FD, Colombo A. Mechanism of late in-stent restenosis after implantation of a paclitaxel derivate-eluting polymer stent system in humans. Circulation. 2002 Nov 19;106(21):2649-51. doi: 10.1161/01.cir.0000041632.02514.14.
PubMed 12438288Carter AJ, Aggarwal M, Kopia GA, Tio F, Tsao PS, Kolata R, Yeung AC, Llanos G, Dooley J, Falotico R. Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in a porcine coronary model. Cardiovasc Res. 2004 Sep 1;63(4):617-24. doi: 10.1016/j.cardiores.2004.04.029.
PubMed 15306217Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004 Feb 17;109(6):701-5. doi: 10.1161/01.CIR.0000116202.41966.D4. Epub 2004 Jan 26.
PubMed 14744976Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K, Yokoyama M. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 2007 Apr;28(8):961-7. doi: 10.1093/eurheartj/ehl413. Epub 2006 Nov 29.
PubMed 17135281Guagliumi G, Sirbu V. Optical coherence tomography: high resolution intravascular imaging to evaluate vascular healing after coronary stenting. Catheter Cardiovasc Interv. 2008 Aug 1;72(2):237-47. doi: 10.1002/ccd.21606.
PubMed 18655155Guagliumi G, Sirbu V, Musumeci G, Bezerra HG, Aprile A, Kyono H, Fiocca L, Matiashvili A, Lortkipanidze N, Vassileva A, Popma JJ, Allocco DJ, Dawkins KD, Valsecchi O, Costa MA. Strut coverage and vessel wall response to a new-generation paclitaxel-eluting stent with an ultrathin biodegradable abluminal polymer: Optical Coherence Tomography Drug-Eluting Stent Investigation (OCTDESI). Circ Cardiovasc Interv. 2010 Aug;3(4):367-75. doi: 10.1161/CIRCINTERVENTIONS.110.950154. Epub 2010 Jul 20.
PubMed 20647562
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optical Coherence Tomography Drug Eluting Stent Investigation(OCTDESI)
- ClinicalTrials.gov ID
- NCT00776204
- Acronym / sponsor ID
- OCTDESI / LBCT-H03-07
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Drug eluting stent, Percutaneous Coronary Interventions, Optical Coherence Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Labcoat, Ltd.
- Study start
- May 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 21 Oct 2008 (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 objective of this study is to evaluate the completeness of struts coverage and vessel wall response to the new generation JACTAX drug-eluting stent vs Taxus stent in de novo coronary artery lesions at 6 months post index procedure. To investigate the completeness of the coverage as well as the number of uncovered stent struts per section, high resolution (~ 10-15 µm axial) intracoronary Optical Coherence Tomography (OCT) will be used.
Detailed description
The risk of late stent thrombosis represents a major concern for patients treated with first generation drug-eluting stents (DES). Delayed healing and poor endothelialization are common findings in vessels treated with DES and are probably related to the amount of drug and polymer applied to a DES. There is evidence to suggest that polymer applications may influence the processes of inflammation and vessel healing. The JACTAX family of DES have been designed to provide a maximum amount of drug delivered directly to coronary vessel tissue while excluding polymer and drug from contact within the vessel lumen. The JACTAX stents are comprised of a currently marketed bare metal stent (Libertè™) coated exclusively on the ablumenal stent surface with a carrier containing a bioerodable polymer, Polylactide and paclitaxel. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the JACTAX stents vs Taxus Libertè in de novo coronary artery lesions at 6 months post index procedure. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at 6 months follow-up. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and at 6 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: JACTAX Drug eluting stentDrug Eluting Stent |
| 2 | Active comparator | Device: JACTAX LD drug eluting stentDrug Eluting Stent |
| 3 | Active comparator | Device: Taxus LibertèDrug Eluting Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- General Inclusion Criteria
- Patient is ≥ 18 years of age
- Patient is eligible for percutaneous coronary intervention (PCI)
- Patient demonstrates a left ventricular ejection fraction (LVEF) of ≥ 25%
- Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect.
Key exclusion criteria (31 listed)
- General Exclusion Criteria
- The patient has a life expectancy of less than 24 months due to another medical condition
- Patient has a history of hypersensitivity to paclitaxel or structurally related compounds
- Patient exhibits cardiogenic shock (systolic pressure < 80mm Hg and PCWP > 20mm Hg or cardiac index <1.8 liters/minute/m2 or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure>80 mm Hg) for any time within 24 hours prior to index procedure
- Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine > 2.0 mg/dl or177 µmol/l)
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 |
|---|---|---|
| JACTAX Drug eluting stentAlso: JACTAX Drug eluting stent (Labcoat Ltd, Galway, Ireland)Jactax stent placed in coronary artery | Device | 1 |
| JACTAX LD drug eluting stentAlso: JACTAX LD Drug eluting stent (Labcoat Ltd, Galway, Ireland)JACTAX LD stent placed in coronary artery | Device | 2 |
| Taxus LibertèAlso: Taxus Libertè (Boston Scientific, Natick, MA)Taxus Libertè stent placed in coronary artery | Device | 3 |
Primary outcome
Proportion of stent struts uncovered and/or malapposed at OCT
Time frame: 6 months
6 secondary outcomes
Major Adverse Cardiac Events (MACE)
Time frame: 12 and 24 months
Stent Thrombosis
Time frame: 12 and 24 months
Target Lesion Revascularization
Time frame: 12 and 24 months
Procedural success
Time frame: through discharge
QCA parameters: mean lumen diameter, acute gain, late loss and binary restenosis (≥ 50% diameter stenosis) rate
Time frame: 6 months
IVUS parameters: neointimal area volume, stent and area volumes, stent apposition, and percent net volume obstruction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Background: PubMed 17325255Luscher TF, Steffel J, Eberli FR, Joner M, Nakazawa G, Tanner FC, Virmani R. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation. 2007 Feb 27;115(8):1051-8. doi: 10.1161/CIRCULATIONAHA.106.675934.
- Background: PubMed 17438147Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.
- Background: PubMed 16003026Kang WC, Han SH, Choi KR, Ahn TH, Shin EK. Acute myocardial infarction caused by late stent thrombosis after deployment of a paclitaxel-eluting stent. J Invasive Cardiol. 2005 Jul;17(7):378-80. No abstract available.
- Background: PubMed 12438288Virmani R, Liistro F, Stankovic G, Di Mario C, Montorfano M, Farb A, Kolodgie FD, Colombo A. Mechanism of late in-stent restenosis after implantation of a paclitaxel derivate-eluting polymer stent system in humans. Circulation. 2002 Nov 19;106(21):2649-51. doi: 10.1161/01.cir.0000041632.02514.14.
- Background: PubMed 15306217Carter AJ, Aggarwal M, Kopia GA, Tio F, Tsao PS, Kolata R, Yeung AC, Llanos G, Dooley J, Falotico R. Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in a porcine coronary model. Cardiovasc Res. 2004 Sep 1;63(4):617-24. doi: 10.1016/j.cardiores.2004.04.029.
- Background: PubMed 14744976Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004 Feb 17;109(6):701-5. doi: 10.1161/01.CIR.0000116202.41966.D4. Epub 2004 Jan 26.
- Background: PubMed 17135281Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K, Yokoyama M. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 2007 Apr;28(8):961-7. doi: 10.1093/eurheartj/ehl413. Epub 2006 Nov 29.
- Background: PubMed 18655155Guagliumi G, Sirbu V. Optical coherence tomography: high resolution intravascular imaging to evaluate vascular healing after coronary stenting. Catheter Cardiovasc Interv. 2008 Aug 1;72(2):237-47. doi: 10.1002/ccd.21606.
- Derived from this study: PubMed 20647562Guagliumi G, Sirbu V, Musumeci G, Bezerra HG, Aprile A, Kyono H, Fiocca L, Matiashvili A, Lortkipanidze N, Vassileva A, Popma JJ, Allocco DJ, Dawkins KD, Valsecchi O, Costa MA. Strut coverage and vessel wall response to a new-generation paclitaxel-eluting stent with an ultrathin biodegradable abluminal polymer: Optical Coherence Tomography Drug-Eluting Stent Investigation (OCTDESI). Circ Cardiovasc Interv. 2010 Aug;3(4):367-75. doi: 10.1161/CIRCINTERVENTIONS.110.950154. Epub 2010 Jul 20.
- Individual participant dataSharing planned: No
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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.
Giulio Guagliumi, MD principal investigator
Cardiovascular Department Ospedali Riuniti di Bergamo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JACTAX Drug eluting stent, JACTAX LD drug eluting stent and Taxus Libertè in people with Coronary Artery Disease, run by Boston Scientific Corporation at 1 site in Italy.
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 8 inclusion and 31 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 1 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 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of stent struts uncovered and/or malapposed at OCT (time frame: 6 months). 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 NCT00776204, which also lists 9 linked publications.
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 1 Mar 2017.