The Arterial Revascularization Therapies Study Part II.

Study Overview
=================
Brief 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.

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.

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.

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: drug-eluting stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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%. Exclusion Criteria: 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). 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cypher Sirolimus-eluting Coronary stent | Device: drug-eluting stent<br>* Cypher Sirolimus-eluting Coronary stent<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abscence of major adverse cardiac and cerebral vascular events (MACCE) |  | 1 year |