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Coronary Artery DiseasePhase 3ARTS IINCT00235170

The Arterial Revascularization Therapies Study Part II.

A Phase 3 study testing drug-eluting stent in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Netherlands.

Completed

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

Official record
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Trial summary

The main objective is to compare the effectiveness of coronary stent implantation using the sirolimus-eluting Bx VELOCITY™ balloon expandable stent with that of surgery as observed in ARTS I. Effectiveness is measured in terms of Major Cardiac and Cerebrovascular Events (MACCE) free survival at 1 year. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
drug-eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
607 participants
Where
1 siteNetherlands
Study dates
Feb 2003to Apr 2009
Phase
Phase 3
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with stable (Canadian Cardiovascular Society 1, 2, 3 or 4) or unstable (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC) angina pectoris and ischemia, or patients with atypical chest pain or even those who are asymptomatic provided they have documented myocardial ischaemia (e.g. treadmill exercise test, radionuclide scintigraphy, stress echocardiography, Holter tape);
  • Patients who are eligible for coronary revascularization (angioplasty or CABG);
  • At least 2 lesions (located in different vessels and in different territories) potentially amenable to stent implantation;
  • de novo native vessels;
  • Multivessel disease with at least one significant stenosis in LAD and with treatment of the lesion in another major epicardial coronary artery. A two-vessel disease or a three-vessel disease may be viewed as a combination of a side branch and a main epicardial vessel provided they supply different territories; left anterior descending, left circumflex and right coronary artery);
  • Total occluded vessels. One total occluded major epicardial vessel or side branch can be included and targeted as long as one other major vessel has a significant stenosis amenable for SA, provided the age of occlusion is less than one month e.g. recent instability, infarction with ECG changes in the area subtended by the occluded vessel. Patients with total occluded vessels of unknown duration or existing longer than one month and a reference over 1.50 mm should not be included, not even as a third or fourth vessel to be dilated;
  • Significant stenosis has been defined as a stenosis of more than 50% in luminal diameter (in at least one view, on visual interpretation or preferably by QCA);
  • Left ventricular ejection fraction should be at least 30%.

Who cannot join

  • Congestive heart failure;
  • CABG or Percutaneous Coronary Intervention (PCI) procedure;
  • Planned need for major surgery (e.g. valve surgery or resection of aortic or left ventricular aneurysm, carotid end-arterectomy, abdominal aortic aneurysm surgery etc.);
  • Congenital heart disease;
  • Transmural myocardial infarction within the previous seven days and CK has not returned to normal;
  • Chest pain lasting longer than 30 minutes within 12 hours pre-procedure, if CK enzymes positive (≥ 2x the normal upper limit).
Show all 10Show fewer
  • History of any cerebrovascular accident;
  • Left main stenosis of 50% or more;
  • Intention to treat more than 1 totally occluded major epicardial vessel;
  • Single vessel (single territory) disease.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Thoraxcenter, Erasmus Medical Center

    Rotterdam, 3015 GD

Other trials in Netherlands

About this study

Official title: ARTS II: Arterial Revascularization Therapies Study Part II of the Sirolimus-Eluting Bx VELOCITY™ Balloon Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions.

The main objective is to compare the effectiveness of coronary stent implantation using the sirolimus-eluting Bx VELOCITY™ balloon expandable stent with that of surgery as observed in ARTS I. Effectiveness is measured in terms of Major Cardiac and Cerebrovascular Events (MACCE) free survival at 1 year.

Read the detailed description

ARTS II is a multicenter, European, open-label, non-randomized, stratified trial in about 45-50 centers which will include six hundred eligible patients with multivessel disease who should be equally treatable by surgery or stenting. In all patients the sirolimus-eluting Bx VELOCITY™ balloon expandable stent of Cordis will be used for treatment.The results of ARTS II will be compared with the by-pass arm of ARTS I as the historical control. It is hypothesized that a similar or higher number of lesions will be treated by stenting. We assume that the use of this eluting stent will not only reduce the rate of MACCE at 30 days, but that it will considerably reduce the need for re-intervention, which was historically 21.0% in ARTS I.

Being tested
drug-eluting stent
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.

  • drug-eluting stentDevice

    Cypher Sirolimus-eluting Coronary stent

Study groups in NCT00235170
Study groupRoleWhat they receive
1ExperimentalCypher Sirolimus-eluting Coronary stent
Receives: Device: drug-eluting stent

What is being measured

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

  1. abscence of major adverse cardiac and cerebral vascular events (MACCE)

    Measured: 1 year

Timeline

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

  1. First posted10 Oct 2005 (estimated)
  2. Study startFeb 2003
  3. Primary completionDec 2004
  4. Study completionApr 2009

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
607 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00235170
Sponsor's protocol ID
EC01-03
Acronym
ARTS II
Status last verified
May 2009
First submitted
4 Oct 2005
Last updated
5 May 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Tsuchida K, Colombo A, Lefevre T, Oldroyd KG, Guetta V, Guagliumi G, von Scheidt W, Ruzyllo W, Hamm CW, Bressers M, Stoll HP, Wittebols K, Donohoe DJ, Serruys PW. The clinical outcome of percutaneous treatment of bifurcation lesions in multivessel coronary artery disease with the sirolimus-eluting stent: insights from the Arterial Revascularization Therapies Study part II (ARTS II). Eur Heart J. 2007 Feb;28(4):433-42. doi: 10.1093/eurheartj/ehl539. Epub 2007 Jan 31.

    PubMed 17267457

  • Valgimigli M, Dawkins K, Macaya C, de Bruyne B, Teiger E, Fajadet J, Gert R, De Servi S, Ramondo A, Wittebols K, Stoll HP, Rademaker TA, Serruys PW. Impact of stable versus unstable coronary artery disease on 1-year outcome in elective patients undergoing multivessel revascularization with sirolimus-eluting stents: a subanalysis of the ARTS II trial. J Am Coll Cardiol. 2007 Jan 30;49(4):431-41. doi: 10.1016/j.jacc.2006.06.081. Epub 2007 Jan 12.

    PubMed 17258088

  • Khattab AA, Daemen J, Richardt G, Rioux P, Amann FW, Levy R, Horvath IG, Teles RC, Ordoubadi F, Pieters M, Wittebols K, Stoll HP, Serruys PW. Impact of body mass index on the one-year clinical outcome of patients undergoing multivessel revascularization with sirolimus-eluting stents (from the Arterial Revascularization Therapies Study Part II). Am J Cardiol. 2008 Jun 1;101(11):1550-9. doi: 10.1016/j.amjcard.2008.02.034. Epub 2008 Apr 9.

    PubMed 18489932

  • Daemen J, Kuck KH, Macaya C, LeGrand V, Vrolix M, Carrie D, Sheiban I, Suttorp MJ, Vranckx P, Rademaker T, Goedhart D, Schuijer M, Wittebols K, Macours N, Stoll HP, Serruys PW; ARTS-II Investigators. Multivessel coronary revascularization in patients with and without diabetes mellitus: 3-year follow-up of the ARTS-II (Arterial Revascularization Therapies Study-Part II) trial. J Am Coll Cardiol. 2008 Dec 9;52(24):1957-67. doi: 10.1016/j.jacc.2008.09.010.

    PubMed 19055986

  • Kukreja N, Serruys PW, De Bruyne B, Colombo A, Macaya C, Richardt G, Fajadet J, Hamm C, Goedhart D, Macours N, Stoll HP; ARTS-II Investigators. Sirolimus-eluting stents, bare metal stents or coronary artery bypass grafting for patients with multivessel disease including involvement of the proximal left anterior descending artery: analysis of the Arterial Revascularization Therapies study part 2 (ARTS-II). Heart. 2009 Jul;95(13):1061-6. doi: 10.1136/hrt.2008.157735. Epub 2009 Mar 19.

    PubMed 19304671

  • Garg S, Sarno G, Garcia-Garcia HM, Girasis C, Wykrzykowska J, Dawkins KD, Serruys PW; ARTS-II Investigators. A new tool for the risk stratification of patients with complex coronary artery disease: the Clinical SYNTAX Score. Circ Cardiovasc Interv. 2010 Aug;3(4):317-26. doi: 10.1161/CIRCINTERVENTIONS.109.914051. Epub 2010 Jul 20.

    PubMed 20647561

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing drug-eluting stent in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Netherlands.

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 10 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 5 May 2009. 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

abscence of major adverse cardiac and cerebral vascular events (MACCE) (time frame: 1 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 NCT00235170, which also lists 6 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 5 May 2009.

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