Coronary AtherosclerosisNEVO RES-INCT00606333
Comparison of the Conor Sirolimus-eluting Coronary Stent to the Taxus Liberte Paclitaxel-eluting Coronary Stent in the Treatment of Coronary Artery Lesions
A study testing NEVO™ Sirolimus-eluting Coronary Stent System and Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System) in people with Coronary Atherosclerosis, run by Cordis US Corp. at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the Conor Sirolimus-eluting Coronary Stent System in the treatment of coronary artery disease (a single atherosclerotic lesion) in native coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Atherosclerosis
- What is being tested?
- NEVO™ Sirolimus-eluting Coronary Stent System and Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2008to Oct 2012
- 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
- 18 years of age or older
- Eligible for percutaneous coronary intervention and coronary artery bypass graft surgery.
- Diagnosis of stable or unstable angina or silent ischemia
- Left ventricular ejection fraction >30%
- The subject requires treatment of a single de novo lesion in a native coronary artery.
- Lesion to be treated is less than or equal to 28 mm in length in a vessel that is 2.5-3.5mm diameter.
Show all 9Show fewer
- The target lesion diameter stenosis is >50% and <100% by visual estimate.
- The target lesion is a minimum of 10 mm distance from any previously treated segment of the target vessel.
- The subject understands the study requirements, is willing to comply with all study procedures and has provided written informed consent.
Who cannot join
- The subject has undergone coronary revascularization to any vessel within 30 days.
- The subject has undergone target vessel revascularization within 6 months.
- Treatment of more than one qualifying lesion is required at the time of enrollment, or is planned within 30 days following enrollment.
- The subject has known sensitivity to sirolimus, paclitaxel, the polymeric matrices, stainless steel or cobalt chromium.
- There is planned treatment of the target lesion with any device other than the pre-dilatation balloon angioplasty catheter.
- The subject had a myocardial infarction within 72 hours, or presents with CK elevation > 2 times upper limit normal associated with elevated CK-MB.
Show all 31Show fewer
- The subject is in cardiogenic shock.
- The subject had a cerebrovascular accident within the past 6 months.
- The subject has acute or chronic renal dysfunction (defined as creatinine >2.0 mg/dl).
- The subject has a contraindication to aspirin or clopidogrel.
- The subject has thrombocytopenia (platelet count < 100,000/mm3.
- The subject has had active gastrointestinal bleeding within the past 3 months.
- The subject has a known bleeding or hypercoagulable disorder.
- The subject has had prior anaphylactoid reaction to contrast agents or has contrast sensitivity that cannot be controlled with pre-medication.
- The subject is currently taking immunosuppressant therapy.
- The subject is currently, or has been treated wtih either Rapamune or paclitaxel within 12 months of the procedure.
- The subject is a female with a positive pregnancy test or is lactating.
- The subject has an active infection.
- The subject has co-morbidities that could interfere wtih completion of study procedures, or life expectancy less than 24 months.
- The subject is participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study.
- Angiographic Exclusion Criteria
- Left main disease >50% diameter stenosis.
- The target lesion is ostial.
- The target lesion or target vessel are severely calcified.
- The target lesion involves a bifurcation with diseased branch vessel greater than or equal to 2.0 mm that would require intervention or protection.
- The target lesion has TIMI o or TIMI I flow.
- Angiographic evidence of thrombus.
- The target vessel has had prior stent placement.
- The patient has had prior coronary brachytherapy.
- There is angiographic restenosis of any previously treated segment of the target vessel, or atherosclerotic area wtih >50% diameter stenosis outside of the target lesion.
- The subject has undergone prior CABG.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized, Multi-Center, Single-Blind Comparison of the Conor Cobalt Chromium Reservoir Based Stent With Sirolimus Elution Versus the TAXUS Liberte Paclitaxel-eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
The purpose of this study is to evaluate the safety and effectiveness of the Conor Sirolimus-eluting Coronary Stent System in the treatment of coronary artery disease (a single atherosclerotic lesion) in native coronary arteries. The study will evaluate the outcomes of a new drug-eluting stent compared to an approved drug-eluting stent.
While Cordis made a business decision to no longer pursue NEVO™ development and commercialization, the patients will be followed up as per protocol. This includes performing all protocol required follow-up visits and the collection and reporting of all safety information.
Read the detailed description
Restenosis remains a frequent cause of late failure following successful coronary angioplasty occurring in an estimated 20-40% of procedures performed. Coronary stents provide mechanical scaffolding that helps reduce restenosis by limiting the extent of elastic recoil and late vascular remodeling. Despite improvements over balloon angioplasty alone, restenosis following coronary stenting procedures has been cited to occur in 20-40% of cases and is primarily a result of neointimal hyperplasia. Thus, stents which are capable of delivering drugs to limit neointimal hyperplasia, in addition to providing mechanical support at the area of the lesion, have been developed to further limit the extent of restenosis following coronary stenting. There are several pharmacologic agents approved for use with drug-eluting stents.Two drugs have been widely studied in controlled clinical trials and real-world patient populations, sirolimus and paclitaxel.
This study will evaluate a new sirolimus-eluting cobalt chromium coronary stent system compared to an approved paclitaxel-eluting coronary stent system in the treatment of single de novo coronary lesions in native coronary arteries. Subjects meeting qualification will be randomized in a 1:1 fashion to treatment with the Conor sirolimus-eluting coronary stent or to treatment with an approved paclitaxel-eluting coronary stent. All subjects will undergo angiographic follow-up at six months and complete clinical follow-up for a period of five years.
- Conditions
- Coronary Atherosclerosis
- Being tested
- NEVO™ Sirolimus-eluting Coronary Stent System, Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)
- Keywords
- Coronary artery disease, drug-eluting stents, sirolimus-eluting coronary stents
- 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.
NEVO™ Sirolimus-eluting Coronary Stent SystemDevice
Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the Conor Cobalt Chromium Sirolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)Device
Also called Taxus Liberte Paclitaxel-eluting Coronary Stent System
Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
| Study group | Role | What they receive |
|---|---|---|
| Investigational arm | Experimental | Subjects randomized to treatment with the NEVO™ Sirolimus-eluting Coronary Stent System. Receives: Device: NEVO™ Sirolimus-eluting Coronary Stent System |
| Control Arm | Active comparator | Subjects randomized to treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System. Receives: Device: Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic endpoint of in-stent late lumen loss as measured by QCA.
Measured: 6 months
Secondary outcomes (12)
Target Lesion Failure defined as cardiac death that cannot be clearly attributed to a non-cardiac event or non-target vessel, target vessel related myocardial infarction or clinically driven target lesion revascularization.
Measured: hospital discharge, 30 days, 6 months and annually through five years.
Target Vessel Failure defined as any myocardial infarction or cardiac death that cannot be attributed to a non-target vessel or any target vessel revascularization.
Measured: Hospital discharge, 30 days, 6 months and annually through five years
Major Adverse Cardiac Events defined as an adjudicated composite of death, emergent coronary artery bypass graft surgery, target lesion revascularization, or new myocardial infarction.
Measured: Hospital discharge, 30 days, 6 months and annually through five years
Incidence of stent thrombosis
Measured: Hospital discharge, 30 days, 6 months and annually through five years
Incidence of target lesion revascularization and target vessel revascularization.
Measured: Hospital discharge, 30 days, 6 months and annually through five years
Device Success
Measured: Procedural
Lesion success
Measured: Procedural
Procedure Success
Measured: Hospital Discharge
Angiographic in-stent and in-segment binary restenosis.
Measured: 6 months
In-stent minimum lumen diameter
Measured: 6 months
Percent volume obstruction of the stent by intravascular ultrasound evaluation
Measured: 6 months
Patient reported outcomes as measured by three standardized quality of life surveys.
Measured: Baseline, 30 days, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2009
- Study completionOct 2012
Why it stopped: The NEVO™ stent will not be commercialized. Cordis have decided to close the study after 3 years. This decision took the absence of safety signals into account.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary AtherosclerosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Conor Medsystems
- Responsible party
- Sponsor
- Investigators
- John Ormiston, MB ChM, Principal investigator, Mercy Angiography UnitAlexandre Abizaid, MD. PhD, Principal investigator, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606333
- Sponsor's protocol ID
- CP-06
- Acronym
- NEVO RES-I
- Status last verified
- Oct 2012
- First submitted
- 17 Jan 2008
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ormiston JA, Abizaid A, Spertus J, Fajadet J, Mauri L, Schofer J, Verheye S, Dens J, Thuesen L, Dubois C, Hoffmann R, Wijns W, Fitzgerald PJ, Popma JJ, Macours N, Cebrian A, Stoll HP, Rogers C, Spaulding C; NEVO ResElution-I Investigators. Six-month results of the NEVO Res-Elution I (NEVO RES-I) trial: a randomized, multicenter comparison of the NEVO sirolimus-eluting coronary stent with the TAXUS Liberte paclitaxel-eluting stent in de novo native coronary artery lesions. Circ Cardiovasc Interv. 2010 Dec;3(6):556-64. doi: 10.1161/CIRCINTERVENTIONS.110.946426. Epub 2010 Nov 9.
PubMed 21062998Otake H, Honda Y, Courtney BK, Shimohama T, Ako J, Waseda K, Macours N, Rogers C, Popma JJ, Abizaid A, Ormiston JA, Spaulding C, Cohen SA, Fitzgerald PJ. Intravascular ultrasound results from the NEVO ResElution-I trial: a randomized, blinded comparison of sirolimus-eluting NEVO stents with paclitaxel-eluting TAXUS Liberte stents in de novo native coronary artery lesions. Circ Cardiovasc Interv. 2011 Apr 1;4(2):146-54. doi: 10.1161/CIRCINTERVENTIONS.110.957175. Epub 2011 Mar 8.
PubMed 21386089Abizaid A, Ormiston JA, Fajadet J, Mauri L, Schofer J, Verheye S, Dens J, Thuesen L, Macours N, Qureshi AC, Spaulding C; NEVO ResElution-I Investigators. Two-year follow-up of the NEVO ResElution-I(NEVO RES-I) trial: a randomised, multicentre comparison of the NEVO sirolimus-eluting coronary stent with the TAXUS Liberte paclitaxel-eluting stent in de novo native coronary artery lesions. EuroIntervention. 2013 Oct;9(6):721-9. doi: 10.4244/EIJV9I6A116.
PubMed 23518218
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Center, Single-Blind Comparison of the Conor Cobalt Chromium Reservoir Based Stent With Sirolimus Elution Versus the TAXUS Liberte Paclitaxel-eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT00606333
- Acronym / sponsor ID
- NEVO RES-I / CP-06
- Conditions
- Coronary Atherosclerosis
- Keywords
- Coronary artery disease, drug-eluting stents, sirolimus-eluting coronary stents
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The NEVO™ stent will not be commercialized. Cordis have decided to close the study after 3 years. This decision took the absence of safety signals into account.
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Collaborators
- Conor Medsystems
- Study start
- Mar 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Feb 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 purpose of this study is to evaluate the safety and effectiveness of the Conor Sirolimus-eluting Coronary Stent System in the treatment of coronary artery disease (a single atherosclerotic lesion) in native coronary arteries. The study will evaluate the outcomes of a new drug-eluting stent compared to an approved drug-eluting stent.
While Cordis made a business decision to no longer pursue NEVO™ development and commercialization, the patients will be followed up as per protocol. This includes performing all protocol required follow-up visits and the collection and reporting of all safety information.
Detailed description
Restenosis remains a frequent cause of late failure following successful coronary angioplasty occurring in an estimated 20-40% of procedures performed. Coronary stents provide mechanical scaffolding that helps reduce restenosis by limiting the extent of elastic recoil and late vascular remodeling. Despite improvements over balloon angioplasty alone, restenosis following coronary stenting procedures has been cited to occur in 20-40% of cases and is primarily a result of neointimal hyperplasia. Thus, stents which are capable of delivering drugs to limit neointimal hyperplasia, in addition to providing mechanical support at the area of the lesion, have been developed to further limit the extent of restenosis following coronary stenting. There are several pharmacologic agents approved for use with drug-eluting stents.Two drugs have been widely studied in controlled clinical trials and real-world patient populations, sirolimus and paclitaxel.
This study will evaluate a new sirolimus-eluting cobalt chromium coronary stent system compared to an approved paclitaxel-eluting coronary stent system in the treatment of single de novo coronary lesions in native coronary arteries. Subjects meeting qualification will be randomized in a 1:1 fashion to treatment with the Conor sirolimus-eluting coronary stent or to treatment with an approved paclitaxel-eluting coronary stent. All subjects will undergo angiographic follow-up at six months and complete clinical follow-up for a period of five years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational arm | Experimental | Device: NEVO™ Sirolimus-eluting Coronary Stent SystemSubjects randomized to treatment with the NEVO™ Sirolimus-eluting Coronary Stent System. |
| Control Arm | Active comparator | Device: Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)Subjects randomized to treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older
- Eligible for percutaneous coronary intervention and coronary artery bypass graft surgery.
- Diagnosis of stable or unstable angina or silent ischemia
- Left ventricular ejection fraction >30%
- The subject requires treatment of a single de novo lesion in a native coronary artery.
Key exclusion criteria (31 listed)
- The subject has undergone coronary revascularization to any vessel within 30 days.
- The subject has undergone target vessel revascularization within 6 months.
- Treatment of more than one qualifying lesion is required at the time of enrollment, or is planned within 30 days following enrollment.
- The subject has known sensitivity to sirolimus, paclitaxel, the polymeric matrices, stainless steel or cobalt chromium.
- There is planned treatment of the target lesion with any device other than the pre-dilatation balloon angioplasty catheter.
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 |
|---|---|---|
| NEVO™ Sirolimus-eluting Coronary Stent SystemIntervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the Conor Cobalt Chromium Sirolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting. | Device | Investigational arm |
| Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)Also: Taxus Liberte Paclitaxel-eluting Coronary Stent SystemIntervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting. | Device | Control Arm |
Primary outcome
Angiographic endpoint of in-stent late lumen loss as measured by QCA.
Time frame: 6 months
12 secondary outcomes
Target Lesion Failure defined as cardiac death that cannot be clearly attributed to a non-cardiac event or non-target vessel, target vessel related myocardial infarction or clinically driven target lesion revascularization.
Time frame: hospital discharge, 30 days, 6 months and annually through five years.
Target Vessel Failure defined as any myocardial infarction or cardiac death that cannot be attributed to a non-target vessel or any target vessel revascularization.
Time frame: Hospital discharge, 30 days, 6 months and annually through five years
Major Adverse Cardiac Events defined as an adjudicated composite of death, emergent coronary artery bypass graft surgery, target lesion revascularization, or new myocardial infarction.
Time frame: Hospital discharge, 30 days, 6 months and annually through five years
Incidence of stent thrombosis
Time frame: Hospital discharge, 30 days, 6 months and annually through five years
Incidence of target lesion revascularization and target vessel revascularization.
Time frame: Hospital discharge, 30 days, 6 months and annually through five years
Device Success
Time frame: Procedural
Lesion success
Time frame: Procedural
Procedure Success
Time frame: Hospital Discharge
Angiographic in-stent and in-segment binary restenosis.
Time frame: 6 months
In-stent minimum lumen diameter
Time frame: 6 months
Percent volume obstruction of the stent by intravascular ultrasound evaluation
Time frame: 6 months
Patient reported outcomes as measured by three standardized quality of life surveys.
Time frame: Baseline, 30 days, 6 months and 12 months
Results and safety
The study was stopped early (reason given: The NEVO™ stent will not be commercialized. Cordis have decided to close the study after 3 years. This decision took the absence of safety signals into account.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
- Results publication: PubMed 21062998Ormiston JA, Abizaid A, Spertus J, Fajadet J, Mauri L, Schofer J, Verheye S, Dens J, Thuesen L, Dubois C, Hoffmann R, Wijns W, Fitzgerald PJ, Popma JJ, Macours N, Cebrian A, Stoll HP, Rogers C, Spaulding C; NEVO ResElution-I Investigators. Six-month results of the NEVO Res-Elution I (NEVO RES-I) trial: a randomized, multicenter comparison of the NEVO sirolimus-eluting coronary stent with the TAXUS Liberte paclitaxel-eluting stent in de novo native coronary artery lesions. Circ Cardiovasc Interv. 2010 Dec;3(6):556-64. doi: 10.1161/CIRCINTERVENTIONS.110.946426. Epub 2010 Nov 9.
- Results publication: PubMed 21386089Otake H, Honda Y, Courtney BK, Shimohama T, Ako J, Waseda K, Macours N, Rogers C, Popma JJ, Abizaid A, Ormiston JA, Spaulding C, Cohen SA, Fitzgerald PJ. Intravascular ultrasound results from the NEVO ResElution-I trial: a randomized, blinded comparison of sirolimus-eluting NEVO stents with paclitaxel-eluting TAXUS Liberte stents in de novo native coronary artery lesions. Circ Cardiovasc Interv. 2011 Apr 1;4(2):146-54. doi: 10.1161/CIRCINTERVENTIONS.110.957175. Epub 2011 Mar 8.
- Derived from this study: PubMed 23518218Abizaid A, Ormiston JA, Fajadet J, Mauri L, Schofer J, Verheye S, Dens J, Thuesen L, Macours N, Qureshi AC, Spaulding C; NEVO ResElution-I Investigators. Two-year follow-up of the NEVO ResElution-I(NEVO RES-I) trial: a randomised, multicentre comparison of the NEVO sirolimus-eluting coronary stent with the TAXUS Liberte paclitaxel-eluting stent in de novo native coronary artery lesions. EuroIntervention. 2013 Oct;9(6):721-9. doi: 10.4244/EIJV9I6A116.
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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.
John Ormiston, MB ChM principal investigator
Mercy Angiography Unit
Alexandre Abizaid, MD. PhD principal investigator
Instituto Dante Pazzanese de Cardiologia
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEVO™ Sirolimus-eluting Coronary Stent System and Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System) in people with Coronary Atherosclerosis, run by Cordis US Corp. at 2 sites in 2 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 9 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: stopped early, as of the sponsor's last update on 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil, New Zealand. 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 was stopped early (reason given: The NEVO™ stent will not be commercialized. Cordis have decided to close the study after 3 years. This decision took the absence of safety signals into account.). Results are not available in the source record.
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?
Angiographic endpoint of in-stent late lumen loss as measured by QCA. (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 NCT00606333, which also lists 3 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 25 Oct 2012.