Status:
UNKNOWN
SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
Cardialysis BV
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing pati...
Detailed Description
Due to the introduction of drug-eluting stents (DESs) and to improvements in therapy for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) patients, PCI is challe...
Eligibility Criteria
Inclusion
- Three-vessel disease, left main disease or LM equivalent with or without 1, 2 or 3VD (left anterior descending \[LAD\], left circumflex \[LCX\], right coronary artery \[RCA\] territory)
- De novo lesions with at least 50% stenosis
- Myocardial ischemia (stable, unstable, silent)
Exclusion
- Prior PCI or CABG
- Acute myocardial infarction (with creatinine kinase \>2x upper limit of normal)
- Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement)
- Participation or planned participation in another cardiovascular clinical study before 1 year follow-up is completed
- Inability to give informed consent due to mental condition, mental retardation, or language barrier
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT00114972
Start Date
March 1 2005
End Date
May 1 2012
Last Update
June 23 2010
Active Locations (106)
Enter a location and click search to find clinical trials sorted by distance.
1
Mercy General Hospital
Sacramento, California, United States, 95819
2
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Florida Cardiovascular Research
Atlantis, Florida, United States, 33462
4
Munroe Medical Center
Ocala, Florida, United States, 34474