Coronary DiseasePhase 4NCT00133237
Drug-eluting-stents for Unprotected Left Main Stem Disease (ISAR-LEFT-MAIN)
A Phase 4 study testing Sirolimus-eluting stent and Paclitaxel-eluting stent in people with Coronary Disease, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
Trial summary
The purpose of this study is to evaluate the efficacy of sirolimus- and paclitaxel-eluting stents for treatment of unprotected left main coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Sirolimus-eluting stent and Paclitaxel-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 607 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2005to Jun 2008
- Phase
- Phase 4
- 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
- Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% stenosis located in unprotected LMCA who are unable to undergo coronary artery bypass graft (CABG)
- Pretreatment with a loading dose of 300-600 mg clopidogrel
- Informed, written consent
Who cannot join
- Cardiogenic shock;
- ST-segment elevation acute myocardial infarction within 48 h from symptom onset;
- In-stent restenosis;
- Malignancies or other comorbid conditions with life expectancy less than one year;
- Prior coronary artery bypass surgery with revascularization of left anterior descending (LAD) and/or left circumflex (LCx) coronary artery
- Planned staged percutaneous coronary intervention (PCI) procedure within 30 days from index procedure or prior PCI within the last 30 days
Show all 11Show fewer
- Left main size >4.5mm
- An elective surgical procedure is planned during the first six months post enrolment;
- Known allergy to the study medications
- Pregnancy
- Patient's inability to fully cooperate with the study protocol
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Deutsches Herzzentrum
Munich, 80636
First Medizinische Klinik, Klinikum rechts der Isar
Munich, 81675
About this study
Official title: Prospective, Randomized Trial of the Sirolimus-Eluting Stent and Paclitaxel-Eluting Stent for the Treatment of Unprotected Left Main Coronary Artery Disease(ISAR-LEFT-MAIN)
The purpose of this study is to evaluate the efficacy of sirolimus- and paclitaxel-eluting stents for treatment of unprotected left main coronary artery disease.
Read the detailed description
With the advent of coronary stents and improvements in periprocedural antithrombotic regimen, the spectrum of indications of percutaneous coronary interventions has continuously expanded for patients with coronary heart disease, gaining ground in what have been traditionally considered as domains of coronary bypass surgery. Several groups reported the outcomes of patients with unprotected left main coronary artery (LMCA) disease treated with stenting. Most of them found that LMCA stenting was feasible and safe, and, in low-risk patients, it was associated with minimal periprocedural complications and low long-term morbidity and mortality. Despite these encouraging reports, a widespread use of this technique has been hampered by the still high incidence of restenosis. It is commonly accepted that coronary bypass graft surgery and stenting for unprotected LMCA disease are associated with similar rates of mortality, and that the higher incidence of restenosis and greater need for revascularization procedures after LMCA stenting remain the major contributors for the observed difference in clinical efficacy between both therapies. The recent introduction of stents eluting anti-restenotic drugs, with sirolimus and paclitaxel the most studied compounds, has opened new perspectives for the prevention of restenosis. Several randomized trials have reported excellent results in the reduction of restenosis and need for reinterventions with drug-eluting stents (DES). Although, none of these trials studied the benefit of DES for lesions located in the LMCA, their results suggested that use of these new devices may be particularly helpful for the reduction of restenosis in the group of patients with left main trunk disease. This is supported by the findings of several series of patients with unprotected LMCA disease who have been successfully treated with DES. Importantly, for patients who are unable to undergo CABG due to cardiac surgeons' refusal (poor surgical candidates) or their own unwillingness, stenting with DES remains the only revascularization alternative. Recent guidelines of PCI recommend stenting, preferentially with DES, for unprotected LMCA in the absence of other revascularization options.
Comparison:
Sirolimus-eluting stents compared with paclitaxel-eluting stent for treatment of lesions allocated at left main trunk.
- Conditions
- Coronary Disease
- Being tested
- Sirolimus-eluting stent, Paclitaxel-eluting stent
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus-eluting stentDevice
Also called Cypher
cypher stent is implanted due to randomization.
Paclitaxel-eluting stentDevice
Also called Taxus
taxus stent is implanted due to randomization.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Sirolimus-eluting stent (Cypher) Receives: Device: Sirolimus-eluting stent |
| B | Active comparator | Paclitaxel-eluting stent (Taxus) Receives: Device: Paclitaxel-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (composite of death, myocardial infarction and target lesion revascularization) at one year
Measured: one year
Secondary outcomes (1)
Angiographic restenosis at 6-9 month follow-up angiography (based on left main area analysis)
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich
- Investigators
- Albert Schömig, MD, Study chair, Deutsches Herzzentrum MuenchenAdnan Kastrati, MD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133237
- Sponsor's protocol ID
- GE IDE No. S02005
- Status last verified
- Oct 2008
- First submitted
- 22 Aug 2005
- Last updated
- 15 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ellis SG, Tamai H, Nobuyoshi M, Kosuga K, Colombo A, Holmes DR, Macaya C, Grines CL, Whitlow PL, White HJ, Moses J, Teirstein PS, Serruys PW, Bittl JA, Mooney MR, Shimshak TM, Block PC, Erbel R. Contemporary percutaneous treatment of unprotected left main coronary stenoses: initial results from a multicenter registry analysis 1994-1996. Circulation. 1997 Dec 2;96(11):3867-72. doi: 10.1161/01.cir.96.11.3867.
PubMed 9403609Park SJ, Park SW, Hong MK, Cheong SS, Lee CW, Kim JJ, Hong MK, Mintz GS, Leon MB. Stenting of unprotected left main coronary artery stenoses: immediate and late outcomes. J Am Coll Cardiol. 1998 Jan;31(1):37-42. doi: 10.1016/s0735-1097(97)00425-7.
PubMed 9426015Takagi T, Stankovic G, Finci L, Toutouzas K, Chieffo A, Spanos V, Liistro F, Briguori C, Corvaja N, Albero R, Sivieri G, Paloschi R, Di Mario C, Colombo A. Results and long-term predictors of adverse clinical events after elective percutaneous interventions on unprotected left main coronary artery. Circulation. 2002 Aug 6;106(6):698-702. doi: 10.1161/01.cir.0000024983.34728.5d.
PubMed 12163430Ellis SG, Hill CM, Lytle BW. Spectrum of surgical risk for left main coronary stenoses: benchmark for potentially competing percutaneous therapies. Am Heart J. 1998 Feb;135(2 Pt 1):335-8. doi: 10.1016/s0002-8703(98)70102-4.
PubMed 9489985Chieffo A, Stankovic G, Bonizzoni E, Tsagalou E, Iakovou I, Montorfano M, Airoldi F, Michev I, Sangiorgi MG, Carlino M, Vitrella G, Colombo A. Early and mid-term results of drug-eluting stent implantation in unprotected left main. Circulation. 2005 Feb 15;111(6):791-5. doi: 10.1161/01.CIR.0000155256.88940.F8. Epub 2005 Feb 7.
PubMed 15699254Valgimigli M, van Mieghem CA, Ong AT, Aoki J, Granillo GA, McFadden EP, Kappetein AP, de Feyter PJ, Smits PC, Regar E, Van der Giessen WJ, Sianos G, de Jaegere P, Van Domburg RT, Serruys PW. Short- and long-term clinical outcome after drug-eluting stent implantation for the percutaneous treatment of left main coronary artery disease: insights from the Rapamycin-Eluting and Taxus Stent Evaluated At Rotterdam Cardiology Hospital registries (RESEARCH and T-SEARCH). Circulation. 2005 Mar 22;111(11):1383-9. doi: 10.1161/01.CIR.0000158486.20865.8B.
PubMed 15781749Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. doi: 10.1093/eurheartj/ehi138. Epub 2005 Mar 15.
PubMed 15769784Mehilli J, Kastrati A, Byrne RA, Bruskina O, Iijima R, Schulz S, Pache J, Seyfarth M, Massberg S, Laugwitz KL, Dirschinger J, Schomig A; LEFT-MAIN Intracoronary Stenting and Angiographic Results: Drug-Eluting Stents for Unprotected Coronary Left Main Lesions Study Investigators. Paclitaxel- versus sirolimus-eluting stents for unprotected left main coronary artery disease. J Am Coll Cardiol. 2009 May 12;53(19):1760-8. doi: 10.1016/j.jacc.2009.01.035.
PubMed 19422982Cassese S, Kufner S, Xhepa E, Byrne RA, Kreutzer J, Ibrahim T, Tiroch K, Valgimigli M, Tolg R, Fusaro M, Schunkert H, Laugwitz KL, Mehilli J, Kastrati A. Three-year efficacy and safety of new- versus early-generation drug-eluting stents for unprotected left main coronary artery disease insights from the ISAR-LEFT MAIN and ISAR-LEFT MAIN 2 trials. Clin Res Cardiol. 2016 Jul;105(7):575-84. doi: 10.1007/s00392-015-0953-x. Epub 2015 Dec 22.
PubMed 26689707Tiroch K, Mehilli J, Byrne RA, Schulz S, Massberg S, Laugwitz KL, Vorpahl M, Seyfarth M, Kastrati A; ISAR-LEFT MAIN Study Investigators. Impact of coronary anatomy and stenting technique on long-term outcome after drug-eluting stent implantation for unprotected left main coronary artery disease. JACC Cardiovasc Interv. 2014 Jan;7(1):29-36. doi: 10.1016/j.jcin.2013.08.013. Epub 2013 Dec 11.
PubMed 24332416
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial of the Sirolimus-Eluting Stent and Paclitaxel-Eluting Stent for the Treatment of Unprotected Left Main Coronary Artery Disease(ISAR-LEFT-MAIN)
- ClinicalTrials.gov ID
- NCT00133237
- Acronym / sponsor ID
- GE IDE No. S02005
- Conditions
- Coronary Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- Technical University of Munich
- Study start
- Jul 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 23 Aug 2005 (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 efficacy of sirolimus- and paclitaxel-eluting stents for treatment of unprotected left main coronary artery disease.
Detailed description
With the advent of coronary stents and improvements in periprocedural antithrombotic regimen, the spectrum of indications of percutaneous coronary interventions has continuously expanded for patients with coronary heart disease, gaining ground in what have been traditionally considered as domains of coronary bypass surgery. Several groups reported the outcomes of patients with unprotected left main coronary artery (LMCA) disease treated with stenting. Most of them found that LMCA stenting was feasible and safe, and, in low-risk patients, it was associated with minimal periprocedural complications and low long-term morbidity and mortality. Despite these encouraging reports, a widespread use of this technique has been hampered by the still high incidence of restenosis. It is commonly accepted that coronary bypass graft surgery and stenting for unprotected LMCA disease are associated with similar rates of mortality, and that the higher incidence of restenosis and greater need for revascularization procedures after LMCA stenting remain the major contributors for the observed difference in clinical efficacy between both therapies. The recent introduction of stents eluting anti-restenotic drugs, with sirolimus and paclitaxel the most studied compounds, has opened new perspectives for the prevention of restenosis. Several randomized trials have reported excellent results in the reduction of restenosis and need for reinterventions with drug-eluting stents (DES). Although, none of these trials studied the benefit of DES for lesions located in the LMCA, their results suggested that use of these new devices may be particularly helpful for the reduction of restenosis in the group of patients with left main trunk disease. This is supported by the findings of several series of patients with unprotected LMCA disease who have been successfully treated with DES. Importantly, for patients who are unable to undergo CABG due to cardiac surgeons' refusal (poor surgical candidates) or their own unwillingness, stenting with DES remains the only revascularization alternative. Recent guidelines of PCI recommend stenting, preferentially with DES, for unprotected LMCA in the absence of other revascularization options.
Comparison:
Sirolimus-eluting stents compared with paclitaxel-eluting stent for treatment of lesions allocated at left main trunk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: Sirolimus-eluting stentSirolimus-eluting stent (Cypher) |
| B | Active comparator | Device: Paclitaxel-eluting stentPaclitaxel-eluting stent (Taxus) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% stenosis located in unprotected LMCA who are unable to undergo coronary artery bypass graft (CABG)
- Pretreatment with a loading dose of 300-600 mg clopidogrel
- Informed, written consent
Key exclusion criteria (11 listed)
- Cardiogenic shock;
- ST-segment elevation acute myocardial infarction within 48 h from symptom onset;
- In-stent restenosis;
- Malignancies or other comorbid conditions with life expectancy less than one year;
- Prior coronary artery bypass surgery with revascularization of left anterior descending (LAD) and/or left circumflex (LCx) coronary artery
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 |
|---|---|---|
| Sirolimus-eluting stentAlso: Cyphercypher stent is implanted due to randomization. | Device | A |
| Paclitaxel-eluting stentAlso: Taxustaxus stent is implanted due to randomization. | Device | B |
Primary outcome
Major adverse cardiac events (composite of death, myocardial infarction and target lesion revascularization) at one year
Time frame: one year
1 secondary outcome
Angiographic restenosis at 6-9 month follow-up angiography (based on left main area analysis)
Time frame: 6-9 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 15 Mar 2010.
- Background: PubMed 9403609Ellis SG, Tamai H, Nobuyoshi M, Kosuga K, Colombo A, Holmes DR, Macaya C, Grines CL, Whitlow PL, White HJ, Moses J, Teirstein PS, Serruys PW, Bittl JA, Mooney MR, Shimshak TM, Block PC, Erbel R. Contemporary percutaneous treatment of unprotected left main coronary stenoses: initial results from a multicenter registry analysis 1994-1996. Circulation. 1997 Dec 2;96(11):3867-72. doi: 10.1161/01.cir.96.11.3867.
- Background: PubMed 9426015Park SJ, Park SW, Hong MK, Cheong SS, Lee CW, Kim JJ, Hong MK, Mintz GS, Leon MB. Stenting of unprotected left main coronary artery stenoses: immediate and late outcomes. J Am Coll Cardiol. 1998 Jan;31(1):37-42. doi: 10.1016/s0735-1097(97)00425-7.
- Background: PubMed 12163430Takagi T, Stankovic G, Finci L, Toutouzas K, Chieffo A, Spanos V, Liistro F, Briguori C, Corvaja N, Albero R, Sivieri G, Paloschi R, Di Mario C, Colombo A. Results and long-term predictors of adverse clinical events after elective percutaneous interventions on unprotected left main coronary artery. Circulation. 2002 Aug 6;106(6):698-702. doi: 10.1161/01.cir.0000024983.34728.5d.
- Background: PubMed 9489985Ellis SG, Hill CM, Lytle BW. Spectrum of surgical risk for left main coronary stenoses: benchmark for potentially competing percutaneous therapies. Am Heart J. 1998 Feb;135(2 Pt 1):335-8. doi: 10.1016/s0002-8703(98)70102-4.
- Background: PubMed 15699254Chieffo A, Stankovic G, Bonizzoni E, Tsagalou E, Iakovou I, Montorfano M, Airoldi F, Michev I, Sangiorgi MG, Carlino M, Vitrella G, Colombo A. Early and mid-term results of drug-eluting stent implantation in unprotected left main. Circulation. 2005 Feb 15;111(6):791-5. doi: 10.1161/01.CIR.0000155256.88940.F8. Epub 2005 Feb 7.
- Background: PubMed 15781749Valgimigli M, van Mieghem CA, Ong AT, Aoki J, Granillo GA, McFadden EP, Kappetein AP, de Feyter PJ, Smits PC, Regar E, Van der Giessen WJ, Sianos G, de Jaegere P, Van Domburg RT, Serruys PW. Short- and long-term clinical outcome after drug-eluting stent implantation for the percutaneous treatment of left main coronary artery disease: insights from the Rapamycin-Eluting and Taxus Stent Evaluated At Rotterdam Cardiology Hospital registries (RESEARCH and T-SEARCH). Circulation. 2005 Mar 22;111(11):1383-9. doi: 10.1161/01.CIR.0000158486.20865.8B.
- Background: PubMed 15769784Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. doi: 10.1093/eurheartj/ehi138. Epub 2005 Mar 15.
- Results publication: PubMed 19422982Mehilli J, Kastrati A, Byrne RA, Bruskina O, Iijima R, Schulz S, Pache J, Seyfarth M, Massberg S, Laugwitz KL, Dirschinger J, Schomig A; LEFT-MAIN Intracoronary Stenting and Angiographic Results: Drug-Eluting Stents for Unprotected Coronary Left Main Lesions Study Investigators. Paclitaxel- versus sirolimus-eluting stents for unprotected left main coronary artery disease. J Am Coll Cardiol. 2009 May 12;53(19):1760-8. doi: 10.1016/j.jacc.2009.01.035.
- Derived from this study: PubMed 26689707Cassese S, Kufner S, Xhepa E, Byrne RA, Kreutzer J, Ibrahim T, Tiroch K, Valgimigli M, Tolg R, Fusaro M, Schunkert H, Laugwitz KL, Mehilli J, Kastrati A. Three-year efficacy and safety of new- versus early-generation drug-eluting stents for unprotected left main coronary artery disease insights from the ISAR-LEFT MAIN and ISAR-LEFT MAIN 2 trials. Clin Res Cardiol. 2016 Jul;105(7):575-84. doi: 10.1007/s00392-015-0953-x. Epub 2015 Dec 22.
- Derived from this study: PubMed 24332416Tiroch K, Mehilli J, Byrne RA, Schulz S, Massberg S, Laugwitz KL, Vorpahl M, Seyfarth M, Kastrati A; ISAR-LEFT MAIN Study Investigators. Impact of coronary anatomy and stenting technique on long-term outcome after drug-eluting stent implantation for unprotected left main coronary artery disease. JACC Cardiovasc Interv. 2014 Jan;7(1):29-36. doi: 10.1016/j.jcin.2013.08.013. Epub 2013 Dec 11.
Related trials for Coronary Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Albert Schömig, MD study chair
Deutsches Herzzentrum Muenchen
Adnan Kastrati, MD principal investigator
Deutsches Herzzentrum Muenchen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sirolimus-eluting stent and Paclitaxel-eluting stent in people with Coronary Disease, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
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 3 inclusion and 11 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 15 Mar 2010. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Major adverse cardiac events (composite of death, myocardial infarction and target lesion revascularization) at one year (time frame: one year). 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 NCT00133237, which also lists 10 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 15 Mar 2010.