The Arterial Revascularization Therapies Study Part II. (ARTS II)

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00235170
First received: October 4, 2005
Last updated: May 4, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: drug-eluting stent
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • abscence of major adverse cardiac and cerebral vascular events (MACCE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 607
Study Start Date: February 2003
Study Completion Date: April 2009
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cypher Sirolimus-eluting Coronary stent
Device: drug-eluting stent
Cypher Sirolimus-eluting Coronary stent

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235170

Locations
Netherlands
Thoraxcenter, Erasmus Medical Center
Rotterdam, Netherlands, 3015 GD
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Patrick W. Serruys, MD, PhD Thoraxcenter, Erasmus Medical Center, Rotterdam
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Hans-Peter Stoll, Cordis
ClinicalTrials.gov Identifier: NCT00235170     History of Changes
Other Study ID Numbers: EC01-03
Study First Received: October 4, 2005
Last Updated: May 4, 2009
Health Authority: Netherlands: Independent Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014