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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
drug-eluting stent
Sponsored by
Cordis Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Thoraxcenter, Erasmus Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Cypher Sirolimus-eluting Coronary stent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 4, 2005
Last Updated
May 4, 2009
Sponsor
Cordis Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00235170
Brief Title
The Arterial Revascularization Therapies Study Part II.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cordis Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
607 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cypher Sirolimus-eluting Coronary stent
Intervention Type
Device
Intervention Name(s)
drug-eluting stent
Intervention Description
Cypher Sirolimus-eluting Coronary stent
Primary Outcome Measure Information:
Title
abscence of major adverse cardiac and cerebral vascular events (MACCE)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick W. Serruys, MD, PhD
Organizational Affiliation
Thoraxcenter, Erasmus Medical Center, Rotterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thoraxcenter, Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
17267457
Citation
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.
Results Reference
result
PubMed Identifier
17258088
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 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.
Results Reference
result
PubMed Identifier
18489932
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 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.
Results Reference
result
PubMed Identifier
19055986
Citation
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.
Results Reference
result
PubMed Identifier
19304671
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 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.
Results Reference
result
PubMed Identifier
20647561
Citation
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.
Results Reference
derived

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The Arterial Revascularization Therapies Study Part II.

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