ACROSS-Cypher Total Occlusion Study of Coronary Arteries 4 Trial

NCT00378612 | Completed Phase 3 DMC

• 2 other identifiers: Pro000079651525004
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 16

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 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.

Conditions

Coronary Occlusions

Keywords

trials; stents; coronary occlusions

Outcome Measures

Primary Outcomes (1)

• Angiographic binary restenosis (>=50% diameter stenosis) in TCO treated/working length compared with restenosis outcomes in the Total Occlusion Study of Canada (TOSCA)

  6 months post-procedure

Secondary Outcomes (13)

• Angiographic binary in-segment restenosis (>= 50% diameter stenosis) rate at 6 months post-procedure

  6 months post-procedure

• Angiographic binary in-stent restenosis (>= 50% diameter stenosis) rate at 6 months post-procedure

  6 months post-procedure

• In-segment late lumen loss at 6 months

  6 months post-procedure

• In-stent late lumen loss at 6 months

  6 months post-procedure

• Device Success

  6 months post-procedure

Study Arms (1)

Cypher® sirolimus eluting coronary stent

EXPERIMENTAL

All pts were given the Cypher sirolimus eluting coronary stent in this open-label, single-arm, non-randomized trial

Device: Cypher sirolimus eluting coronary stent

Interventions

Cypher sirolimus eluting coronary stent DEVICE

Cypher® sirolimus eluting coronary stent ranging in diameters 2.5 to 3.5 mm and available in length from 8 to 33 mm.

Cypher® sirolimus eluting coronary stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sunil Rao: lead
• Cordis US Corp.: collaborator

Study Sites (16)

Green Hospital of Scripps Health

La Jolla, California, 92037, United States

Location

Scripps Memorial Hospital-La Jolla

La Jolla, California, 92037, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Saint Lukes Hospital

Kansas City, Missouri, 64111, United States

Location

New York Presbyterian Medical

New York, New York, 10032, United States

Location

The Sanger Clinic PA

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

North Ohio Heart Center

Elyria, Ohio, 44035, United States

Location

Heart Hospital of Austin

Austin, Texas, 78756, United States

Location

Vancouver Hospital and Health Science Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Saint Michaels Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

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  PMID: 7867195 RESULT

• Kandzari DE, Rao SV, Moses JW, Dzavik V, Strauss BH, Kutryk MJ, Simonton CA, Garg J, Lokhnygina Y, Mancini GB, Yeoh E, Buller CE; ACROSS/TOSCA-4 Investigators. Clinical and angiographic outcomes with sirolimus-eluting stents in total coronary occlusions: the ACROSS/TOSCA-4 (Approaches to Chronic Occlusions With Sirolimus-Eluting Stents/Total Occlusion Study of Coronary Arteries-4) trial. JACC Cardiovasc Interv. 2009 Feb;2(2):97-106. doi: 10.1016/j.jcin.2008.10.013.

  PMID: 19463409 DERIVED

MeSH Terms

Conditions

Coronary Occlusion

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Sunil Rao, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Medicine - Cardiology

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 20, 2006
• Study Start: June 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: September 1, 2012
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

US (13); CA (3)