The Arterial Revascularization Therapies Study Part II.

Coronary Artery Disease Clinical Trial

— ARTS II  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235170
• Other study ID #: EC01-03
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2005
• Last updated: May 4, 2009
• Start date: February 2003
• Est. completion date: April 2009

Study information

• Verified date: May 2009
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 607
• Est. completion date: April 2009
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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);

2. Patients who are eligible for coronary revascularization (angioplasty or CABG);

3. At least 2 lesions (located in different vessels and in different territories) potentially amenable to stent implantation;

4. de novo native vessels;

5. 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);

6. 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;

7. 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);

8. Left ventricular ejection fraction should be at least 30%.

Exclusion Criteria:

1. Congestive heart failure;

2. CABG or Percutaneous Coronary Intervention (PCI) procedure;

3. 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.);

4. Congenital heart disease;

5. Transmural myocardial infarction within the previous seven days and CK has not returned to normal;

6. Chest pain lasting longer than 30 minutes within 12 hours pre-procedure, if CK enzymes positive (= 2x the normal upper limit).

7. History of any cerebrovascular accident;

8. Left main stenosis of 50% or more;

9. Intention to treat more than 1 totally occluded major epicardial vessel;

10. Single vessel (single territory) disease.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• drug-eluting stent
Cypher Sirolimus-eluting Coronary stent

Locations

Country	Name	City	State
Netherlands	Thoraxcenter, Erasmus Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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 — View Citation

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 w — View Citation

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 di — View Citation

Tsuchida K, Colombo A, Lefèvre 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 coronar — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abscence of major adverse cardiac and cerebral vascular events (MACCE)		1 year	Yes