Status:
COMPLETED
Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Disease
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx drug-eluting stent in patients with blockage of native coronary arteries. The study is designed to demonstrate non-inf...
Detailed Description
Heart disease is the leading cause of death in Europe as a whole, and while mortality rates for cardiovascular disease have decreased in most western European countries, due to expanded use of prevent...
Eligibility Criteria
Inclusion
- Inclusion Criteria include all of the following:
- Subject is ≥ 18 years old.
- Female of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable birth control for nine (9) months after enrollment.
- Subject is eligible for percutaneous coronary intervention (PCI) and has a single lesion requiring treatment.
- Subject is an acceptable candidate for CABG.
- Subject has clinical evidence of ischemic heart disease or a positive functional study.
- Subject has documented stable angina pectoris
- Exclusion Criteria include all of the following:
- Evidence of an acute myocardial infarction (AMI) or CK-MB \> 2x upper limit of normal within 72 hours of the intended treatment (refer to WHO definition).
- Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, stainless steel, tantalum, contrast agent (that cannot be adequately premedicated), paclitaxel, or drugs similar to ABT-578 (i.e. tacrolimus, sirolimus, everolimus).
- A platelet count \< 100 x 109/L or \> 700 x 109/L (\< 100,000 cells/mm3 or \> 700,000 cells/mm3); a WBC \< 3,000 cells/mm3; or a hemoglobin \< 10.0 g/dl.
- Acute or chronic renal dysfunction (creatinine \> 2.0 mg/dl or \> 150 µmol/L).
- Subject has had any previous or planned brachytherapy in the target vessel.
- Target vessel has evidence of thrombus or is excessively tortuous (\> 60 degree bend) that makes it unsuitable for proper stent delivery and deployment.
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT00148356
Start Date
September 1 2004
End Date
October 1 2010
Last Update
April 1 2011
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
2
Monash Medical Center
Victoria, Australia, 3168
3
Onze Lieve Vrouw Hospital
Aalst, Belgium, 9300
4
Middelheim Algemeen Ziekenhuis
Antwerp, Belgium, 2020