Status:
COMPLETED
ACROSS-Cypher Total Occlusion Study of Coronary Arteries 4 Trial
Lead Sponsor:
Sunil Rao
Collaborating Sponsors:
Cordis US Corp.
Conditions:
Coronary Occlusions
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
ACROSS-Cypher® is a prospective, multi-center, open label, single arm study of the Cypher® sirolimus eluting coronary stent in native total coronary occlusion revascularization. The primary endpoint i...
Detailed Description
Despite remarkable advances in the procedural and clinical outcomes of percutaneous revascularization, chronically occluded coronary arteries remain a formidable challenge and unresolved dilemma in in...
Eligibility Criteria
Inclusion
- Patients age 18 years or older at time of consent
- Patients with clinical symptoms suggesting ischemic heart disease or having evidence of myocardial ischemia and scheduled for clinically indicated percutaneous revascularization
- Eligibility and consent to undergo PCI procedure
- Patient is an acceptable candidate for percutaneous transluminal coronary angioplasty,stenting,and emergency coronary artery bypass grafting
- Willing and able to sign informed consent form approved by local IRB/Ethics Committee and to follow protocol, including 6-month follow-up angiography
- At least 1 target segment meeting definition of non-acute total coronary occlusion
- High-grade native coronary stenosis
- Thrombolysis in Myocardial Infarction 0 or 1 antegrade flow
- Target occlusion successfully crossed with commercially available coronary guidewire
- Occluded segment suitable for placement of coronary stents
- Treated segment can accommodate 3.0mm or greater diameter balloon
- Segment not beyond severe tortuosity (45° or more) or excessively distal location
Exclusion
- Patients undergoing treatment of a non-target vessel that is also a total coronary occlusion
- Patients with any history of allergy to iodinated contrast that cannot be effectively managed medically, or any known allergy to clopidogrel bisulfate (Plavix®), aspirin, heparin, ticlopidine, stainless steel, or sirolimus
- Evidence of acute myocardial infarction within 72 hours of intended treatment (Q-wave or non-Q-wave myocardial infarction having creatine kinase enzymes 2X the upper limit of normal with presence of a creatine kinase myocardial-band isoenzyme above Institution's ULN, or troponin above the Institution's ULN)
- Previous coronary interventional procedure of any kind within 3 months prior to the procedure in target vessel
- Planned interventional treatment of either target or any non-target vessel within 30 days post-procedure with a bare metal or Cypher® sirolimus eluting coronary stent
- Planned interventional treatment of either the target or any non-target vessel within 6 months post-procedure with a paclitaxel-eluting TAXUSTM stent
- Any contraindication to cardiac catheterization or to any standard concomitant therapies used during routine cardiac catheterization and PCI
- Target lesion requires planned treatment with a device after successful crossing other than PTCA prior to stent
- Patients with history of clinically significant abnormal laboratory findings including
- Current (within previous two weeks) neutropenia (\<1000 neutrophils/mm3)
- Thrombocytopenia (\<100,000 platelets/mm3)
- AST, ALT, alkaline phosphatase, or bilirubin \> 1.5XULN
- Serum creatinine \> 1.5 mg/dL
- Patients with evidence of ongoing or active clinical instability including the following
- Sustained systolic blood pressure \< 100mmHg or cardiogenic shock
- Acute pulmonary edema or severe congestive heart failure
- Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade
- Suspected dissecting aortic aneurysm
- Hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease
- Target lesion involves a bifurcation including a diseased side branch 2.25mm or more in diameter requiring treatment
- Prior coronary bypass surgery of target lesion with patent bypass graft (balloon angioplasty alone, without coronary stenting, is permitted)
- History of stroke or transient ischemic attack within prior 6 months
- Female patients of childbearing potential
- Active peptic ulcer or upper gastrointestinal bleeding within prior 6 months
- History of bleeding diathesis or coagulopathy or refusal of blood transfusions
- Patients with any other pathology such as cancer, mental illness, which in the opinion of the investigator, might put the patient at risk, preclude follow-up, or in any way confound the results of the study
- Known previous medical condition yielding expected survival less than 1 year
- Patients who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements
- Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound, or other coronary artery imaging procedures
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00378612
Start Date
June 1 2005
End Date
September 1 2012
Last Update
September 12 2014
Active Locations (16)
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1
Green Hospital of Scripps Health
La Jolla, California, United States, 92037
2
Scripps Memorial Hospital-La Jolla
La Jolla, California, United States, 92037
3
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
4
Emory University
Atlanta, Georgia, United States, 30322