Coronary Heart DiseasePhase 4ORAR IIINCT00552669

Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents

A Phase 4 study testing Oral sirolimus and Drug Eluting stent in people with Coronary Heart Disease and Coronary Restenosis, run by Centro de estudios en Cardiologia Intervencionista at 3 sites in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Heart Disease, Coronary Restenosis
What is being tested?: Oral sirolimus and Drug Eluting stent
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 3 sitesArgentina
Study dates: Jan 2006to Sep 2007
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Indication of revascularization
De novo lesions
Native vessels
Suitable for stent placement

Who cannot join

Acute myocardial infarction within the last 24 hours
In stent restenosis
Previous percutaneous coronary intervention within the last 6 months

Trial locations and contacts

3 sites in 1 country.

Argentina3 sites

Clinica IMA
Adrogué, Buenos Aires, 1846
Sanatorio Otamendi y Miroli
Buenos Aires, Buenos Aires, 1115
Sanatorio Las Lomas
San Isidro, Buenos Aires, 1354

Other trials in Argentina

About this study

Official title: Phase 4 Study of Randomized Comparison Among Oral Rapamycin Plus Bare Metal Stents Versus Drug Eluting Stents in de Novo Coronary Lesions.

In a previous randomized comparison oral sirolimus plus bare metal stent compared to bare metal stent implantation alone demonstrated at one year of follow up a significant reduction of angiographic and clinical parameters of restenosis (ANMAT resolution number 3366 from June 2004 and Rodriguez A et al JACC,2006,47,1522-1529). In addition previous reported registries from our group with Drug Eluting Stents showed similar amount of reduction in clinical parameters (not angiographic)of restenosis (ERACI III, Rodriguez A et al EuroIntervention 2006,2:53-60). Taking in account that 8.3% of patients treated with oral rapamycin plus Bare Metal Stents(ORAR II Trial JACC 2006)and 8.8% of patients treated with DES developed clinical restenosis (ERACI III Registry, EuroIntervention 2006) the investigators sought to compare differences in overall cost with both revascularization strategies at 1, 2, 3 and 5 years of follow up assuming that safety and efficacy clinical end points would be similar.

Read the detailed description

Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina were randomized to treat with oral sirolimus plus bare metal stent implantation (100 patients) or DES(100 patients).

Conditions: Coronary Heart Disease, Coronary Restenosis
Being tested: Oral sirolimus, Drug Eluting stent
Keywords: Drug Eluting Stents, Stents Bare Metal, Stent Thrombosis, Coronary revascularization, Survival
Medical subject headings: Coronary Disease, Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral sirolimusDrug
Also called Oral rapamycine
Oral sirolimus given orally during 14 days plus bare metal stent implantation was compared with DES.Oral sirolimus was given as bolus of 10 mg started day before intervention followed by 3mg per day during 13 days after PCI. 180 mg of Diltiazem was added during oral administration of sirolimus .
Drug Eluting stentDevice
Also called DES=Drug Eluting Stents), PES (Paclitaxel Eluting Stent), SES (Sirolimus eluting stent), ZES (Zotarolimus eluting stent)
Any Drug eluting stent

Study groups in NCT00552669
Study group	Role	What they receive
A--Oral Rapamycin plus BMS	Experimental	Oral sirolimus plus bare metal stent implantation Receives: Drug: Oral sirolimus
B -- Drug Eluting Stent	Active comparator	Drug Eluting Stents Receives: Device: Drug Eluting stent

What is being measured

The primary outcome is the main question the study is designed to answer.

Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.
Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.
Measured: Follow up will be conducted by the coordinating Center at 18 months of follow up

Secondary outcomes (2)

Major Adverse Cardiovascular Events (MACCE)
Death from any cause, myocardial infarction and stroke. Safety was analyzed as MACCE (major adverse cardiovascular events) including death, MI and stroke.
Measured: 18 Months
Target Vessel Revascularization (TVR)
Efficacy end point was TVR as revasacularization of the treated vessel.
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Sep 2007

First posted2 Nov 2007 (estimated)
Study startJan 2006
Primary completionSep 2007
Study completionSep 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (39)Papers the sponsor has linked to this study.
Other trials for Coronary Heart 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00552669
Sponsor's protocol ID: 1-Rodriguez
Other IDs: 01-CECI, 02-IMA
Acronym: ORAR III
Status last verified: May 2009
First submitted: 1 Nov 2007
Last updated: 2 Jun 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
PubMed 12050336
Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.
PubMed 14523139
Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G; E-SIRIUS Investigators. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet. 2003 Oct 4;362(9390):1093-9. doi: 10.1016/S0140-6736(03)14462-5.
PubMed 14550694
Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004 Jan 15;350(3):221-31. doi: 10.1056/NEJMoa032441.
PubMed 14724301
Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME; TAXUS II Study Group. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation. 2003 Aug 19;108(7):788-94. doi: 10.1161/01.CIR.0000086926.62288.A6. Epub 2003 Aug 4.
PubMed 12900339
Virmani 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 14744976
Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, Jeger R, Bader F, Osswald S, Kaiser C; BASKET-LATE Investigators. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol. 2006 Dec 19;48(12):2584-91. doi: 10.1016/j.jacc.2006.10.026. Epub 2006 Nov 2.
PubMed 17174201
Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007 Mar 8;356(10):989-97. doi: 10.1056/NEJMoa066633. Epub 2007 Feb 12.
PubMed 17296825
McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9.
PubMed 15500897
Rodriguez AE, Mieres J, Fernandez-Pereira C, Vigo CF, Rodriguez-Alemparte M, Berrocal D, Grinfeld L, Palacios I. Coronary stent thrombosis in the current drug-eluting stent era: insights from the ERACI III trial. J Am Coll Cardiol. 2006 Jan 3;47(1):205-7. doi: 10.1016/j.jacc.2005.10.016. Epub 2005 Dec 9. No abstract available.
PubMed 16386687
Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007 Feb 24;369(9562):667-78. doi: 10.1016/S0140-6736(07)60314-6.
PubMed 17321312
Hofma SH, van der Giessen WJ, van Dalen BM, Lemos PA, McFadden EP, Sianos G, Ligthart JM, van Essen D, de Feyter PJ, Serruys PW. Indication of long-term endothelial dysfunction after sirolimus-eluting stent implantation. Eur Heart J. 2006 Jan;27(2):166-70. doi: 10.1093/eurheartj/ehi571. Epub 2005 Oct 25.
PubMed 16249221
Gallo R, Padurean A, Jayaraman T, Marx S, Roque M, Adelman S, Chesebro J, Fallon J, Fuster V, Marks A, Badimon JJ. Inhibition of intimal thickening after balloon angioplasty in porcine coronary arteries by targeting regulators of the cell cycle. Circulation. 1999 Apr 27;99(16):2164-70. doi: 10.1161/01.cir.99.16.2164.
PubMed 10217658
Poon M, Marx SO, Gallo R, Badimon JJ, Taubman MB, Marks AR. Rapamycin inhibits vascular smooth muscle cell migration. J Clin Invest. 1996 Nov 15;98(10):2277-83. doi: 10.1172/JCI119038.
PubMed 8941644
Rodriguez AE, Alemparte MR, Vigo CF, Pereira CF, Llaurado C, Russo M, Virmani R, Ambrose JA. Pilot study of oral rapamycin to prevent restenosis in patients undergoing coronary stent therapy: Argentina Single-Center Study (ORAR Trial). J Invasive Cardiol. 2003 Oct;15(10):581-4.
PubMed 14519892

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 4 Study of Randomized Comparison Among Oral Rapamycin Plus Bare Metal Stents Versus Drug Eluting Stents in de Novo Coronary Lesions.
ClinicalTrials.gov ID: NCT00552669
Acronym / sponsor ID: ORAR III / 1-Rodriguez
Conditions: Coronary Heart Disease, Coronary Restenosis
Keywords: Drug Eluting Stents, Stents Bare Metal, Stent Thrombosis, Coronary revascularization, Survival
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Centro de estudios en Cardiologia IntervencionistaUniversity, hospital or other
Study start: Jan 2006
Primary completion: Sep 2007 (actual)
Study completion: Sep 2007 (actual)
First posted: 2 Nov 2007 (estimated)
Results: Posted 20 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A--Oral Rapamycin plus BMS	Experimental	Drug: Oral sirolimusOral sirolimus plus bare metal stent implantation
B -- Drug Eluting Stent	Active comparator	Device: Drug Eluting stentDrug Eluting Stents

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Indication of revascularization
De novo lesions
Native vessels
Suitable for stent placement

Key exclusion criteria (3 listed)

Acute myocardial infarction within the last 24 hours
In stent restenosis
Previous percutaneous coronary intervention within the last 6 months

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
Oral sirolimusAlso: Oral rapamycineOral sirolimus given orally during 14 days plus bare metal stent implantation was compared with DES.Oral sirolimus was given as bolus of 10 mg started day before intervention followed by 3mg per day during 13 days after PCI. 180 mg of Diltiazem was added during oral administration of sirolimus .	Drug	A--Oral Rapamycin plus BMS
Drug Eluting stentAlso: DES=Drug Eluting Stents), PES (Paclitaxel Eluting Stent), SES (Sirolimus eluting stent), ZES (Zotarolimus eluting stent)Any Drug eluting stent	Device	B -- Drug Eluting Stent

Primary outcome

Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.
Time frame: Follow up will be conducted by the coordinating Center at 18 months of follow up
Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.

2 secondary outcomes

Major Adverse Cardiovascular Events (MACCE)
Time frame: 18 Months
Target Vessel Revascularization (TVR)
Time frame: 18 months

Results and safety

Results posted to the registry on 20 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral Sirolimus + Bare Metal Stent	100	97
Drug Eluting Stents	100	93

Primary outcome: Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.

Time frame: Follow up will be conducted by the coordinating Center at 18 months of follow up. Mean (Standard Deviation). Unit: US dollars

Measure	Oral Sirolimus + Bare Metal Stent n = 100	Drug Eluting Stents n = 100
Value	5483 (2165.5)	7658.2 (3263.4)

Oral Sirolimus + Bare Metal Stent vs Drug Eluting Stents: p <0.05, ANOVA

Population analysed: All patients were analyzed for ITT and the imputation technique was LOCF

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: One year. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral Sirolimus + Bare Metal Stent	9 of ?	9 of 100 (9%)	Not reported
Drug Eluting Stents	15 of ?	2 of 100 (2%)	Not reported

Limitations and caveats (from the sponsor): It was an open label design. Multiple approved DES designs were used. Health Care system in Argentina differs from other world ones.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12050336Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
Background: PubMed 14523139Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.
Background: PubMed 14550694Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G; E-SIRIUS Investigators. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet. 2003 Oct 4;362(9390):1093-9. doi: 10.1016/S0140-6736(03)14462-5.
Background: PubMed 14724301Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004 Jan 15;350(3):221-31. doi: 10.1056/NEJMoa032441.
Background: PubMed 12900339Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME; TAXUS II Study Group. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation. 2003 Aug 19;108(7):788-94. doi: 10.1161/01.CIR.0000086926.62288.A6. Epub 2003 Aug 4.
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 17174201Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, Jeger R, Bader F, Osswald S, Kaiser C; BASKET-LATE Investigators. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol. 2006 Dec 19;48(12):2584-91. doi: 10.1016/j.jacc.2006.10.026. Epub 2006 Nov 2.
Background: PubMed 17296825Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007 Mar 8;356(10):989-97. doi: 10.1056/NEJMoa066633. Epub 2007 Feb 12.
Background: PubMed 15500897McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9.
Background: PubMed 16386687Rodriguez AE, Mieres J, Fernandez-Pereira C, Vigo CF, Rodriguez-Alemparte M, Berrocal D, Grinfeld L, Palacios I. Coronary stent thrombosis in the current drug-eluting stent era: insights from the ERACI III trial. J Am Coll Cardiol. 2006 Jan 3;47(1):205-7. doi: 10.1016/j.jacc.2005.10.016. Epub 2005 Dec 9. No abstract available.
Background: PubMed 17321312Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007 Feb 24;369(9562):667-78. doi: 10.1016/S0140-6736(07)60314-6.
Background: PubMed 16249221Hofma SH, van der Giessen WJ, van Dalen BM, Lemos PA, McFadden EP, Sianos G, Ligthart JM, van Essen D, de Feyter PJ, Serruys PW. Indication of long-term endothelial dysfunction after sirolimus-eluting stent implantation. Eur Heart J. 2006 Jan;27(2):166-70. doi: 10.1093/eurheartj/ehi571. Epub 2005 Oct 25.
Pubmed abstract of the latest published results.Link provided by the sponsor.

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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.

Alfredo E Rodriguez, MD PhD FACC study chair

Departamento de Cardiologia Intervencionista, Sanatorio Otamendi

Carlos Fernandez Pereira, MD study director

Departamento de Cardiologia Intervencionista, Sanatorio Otamendi

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 3 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 2 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Argentina. 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?

Yes. Results are posted in the registry (first posted 20 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions. (time frame: Follow up will be conducted by the coordinating Center at 18 months of follow up). 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 NCT00552669, which also lists 39 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 2 Jun 2010.