ACROSS-Cypher Total Occlusion Study of Coronary Arteries 4 Trial

Completed · Phase 3

Conditions studied: Coronary Occlusions

In brief

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 is binary angiographic restenosis at 6 months. The TOSCA-1 trial will be used as the historical control. The hypothesis is that compared with TOSCA-1 patients who were treated with the heparin-coated Palmaz Schatz stent, treatment with the Cypher® sirolimus eluting coronary stent will result in a \>50% relative reduction in 6 month restenosis within the treated segment of the target vessel.

Key facts

Study ID: NCT00378612
Run by: Sunil Rao
People needed: 200
Starts: 2005-06-01
Expected to finish: 2012-09-01
Last updated by the study team: 2014-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Green Hospital of Scripps Health — La Jolla, California, United States
Scripps Memorial Hospital-La Jolla — La Jolla, California, United States
Washington Hospital Center — Washington D.C., District of Columbia, United States
Emory University — Atlanta, Georgia, United States
Brigham and Womens Hospital — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
William Beaumont Hospital — Royal Oak, Michigan, United States
Saint Lukes Hospital — Kansas City, Missouri, United States
New York Presbyterian Medical — New York, New York, United States
The Sanger Clinic PA — Charlotte, North Carolina, United States
Duke University Medical Center — Durham, North Carolina, United States
North Ohio Heart Center — Elyria, Ohio, United States
Heart Hospital of Austin — Austin, Texas, United States
Vancouver Hospital and Health Science Centre — Vancouver, British Columbia, Canada
Saint Michaels Hospital — Toronto, Ontario, Canada
Toronto General Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.