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ACROSS-Cypher Total Occlusion Study of Coronary Arteries 4 Trial

Primary Purpose

Coronary Occlusions

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cypher sirolimus eluting coronary stent
Sponsored by
Sunil Rao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Occlusions focused on measuring trials, stents, coronary occlusions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Green Hospital of Scripps Health
  • Scripps Memorial Hospital-La Jolla
  • Washington Hospital Center
  • Emory University
  • Brigham and Womens Hospital
  • Beth Israel Deaconess Medical Center
  • William Beaumont Hospital
  • Saint Lukes Hospital
  • New York Presbyterian Medical
  • The Sanger Clinic PA
  • Duke University Medical Center
  • North Ohio Heart Center
  • Heart Hospital of Austin
  • Vancouver Hospital and Health Science Centre
  • Saint Michaels Hospital
  • Toronto General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cypher® sirolimus eluting coronary stent

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Angiographic binary in-segment restenosis (>= 50% diameter stenosis) rate at 6 months post-procedure
Angiographic binary in-stent restenosis (>= 50% diameter stenosis) rate at 6 months post-procedure
In-segment late lumen loss at 6 months
In-stent late lumen loss at 6 months
Device Success
Lesion Success
Procedure Success
Major Adverse Cardiac Events (MACE) rate at 30 days, 6 months, and 12 months post-procedure
Target Site Revascularization (TSR) rate and clinically-driven TSR rate at 6 and 12 months post-procedure Target Vessel Revascularization (TVR) rate and clinically-driven TVR rate at 6 and 12 months post-procedure
Target Vessel Failure (TVF) rate at 6 and 12 months post-procedure
In-stent and in-segment minimum lumen diameter (MLD) at 6 months post-procedure
Failure of sustained patency at 6 months (≥70% stenosis with TIMI <3 flow at follow-up angiography)
Subacute thrombosis occurring within 30 days post-procedure

Full Information

First Posted
September 19, 2006
Last Updated
September 11, 2014
Sponsor
Sunil Rao
Collaborators
Cordis Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00378612
Brief Title
ACROSS-Cypher Total Occlusion Study of Coronary Arteries 4 Trial
Official Title
Approaches to Chronic Occlusions With Sirolimus Stents-Cypher (ACROSS-Cypher) Total Occlusion Study of Coronary Arteries 4 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sunil Rao
Collaborators
Cordis Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 interventional cardiology. Although a TCO is identified in approximately one-third of diagnostic cardiac catheterizations, still an attempted revascularization accounts for less than 8% of all percutaneous coronary interventions (PCI). Such a disparity between their frequency and treatment not only underscores the technical and procedural frustrations associated with these complex lesions, but also the clinical uncertainties regarding clinical benefits with conventional TCO revascularization and the ongoing inadequacies of current PCI methods for sustaining restenosis-free patency following initial success. Until recently, few clinical investigations have been performed to support clinical benefit of TCO revascularization. In addition to relief of symptomatic ischemia, theoretical advantages have included enhanced left ventricular function, reduced predisposition to arrhythmic events, and improved tolerance of future ischemic events. In the Survival and Ventricular Enlargement (SAVE) trial, persistent occlusion of the infarct-related artery was associated with a relative risk of 1.47 in adjusted 4-year mortality (P=0.04). Since then, a limited number of studies documenting long-term outcomes following intended TCO revascularization have been performed. This investigational protocol is designed to evaluate the safety and efficacy of the Cypher® sirolimus eluting coronary stent (Cordis Corporation, Miami Lakes, FL) in patients undergoing elective revascularization of nonacute total coronary occlusions (TCO). Specifically, approximately 200 patients will undergo Cypher® sirolimus eluting coronary stent(s) implantation following successful crossing of native total occlusions with a coronary guidewire. The study will be conducted at approximately 17 sites in North America. Patients included in this trial will be scheduled for percutaneous revascularization of a non-acute de novo TCO in a native vessel visually estimated to accommodate a ≥3.0 mm diameter angioplasty balloon. Important exclusion criteria will include recent myocardial infarction (<72 hours) and any general contraindication to the procedure or scheduled clinical and angiographic follow-up. Patients may also undergo treatment of a non-target vessel lesion simultaneous with the index procedure within certain protocol-specified provisions. All patients will undergo planned angiographic follow-up 6 months following the index procedure to evaluate the primary endpoint of restenosis (>50% diameter stenosis) within the treated/working length segment compared with results obtained using the same methodology among patients undergoing TCO revascularization with the heparin-coated Palmaz-Schatz coronary stent (Cordis Corporation, Miami Lakes, FL) in the Total Occlusion Study of Canada-1 (TOSCA) (1). Important secondary endpoints include the occurrence of major adverse cardiac events (MACE) and target vessel failure (TVF) at 30 days, 6 months and 12 months post-procedure. In addition, angiographic outcomes of in-stent and segment restenosis within the stent and segment will be examined. Further, patients enrolled in the trial will have clinical follow-up annually to five years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Occlusions
Keywords
trials, stents, coronary occlusions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cypher® sirolimus eluting coronary stent
Arm Type
Experimental
Arm Description
All pts were given the Cypher sirolimus eluting coronary stent in this open-label, single-arm, non-randomized trial
Intervention Type
Device
Intervention Name(s)
Cypher sirolimus eluting coronary stent
Intervention Description
Cypher® sirolimus eluting coronary stent ranging in diameters 2.5 to 3.5 mm and available in length from 8 to 33 mm.
Primary Outcome Measure Information:
Title
Angiographic binary restenosis (>=50% diameter stenosis) in TCO treated/working length compared with restenosis outcomes in the Total Occlusion Study of Canada (TOSCA)
Time Frame
6 months post-procedure
Secondary Outcome Measure Information:
Title
Angiographic binary in-segment restenosis (>= 50% diameter stenosis) rate at 6 months post-procedure
Time Frame
6 months post-procedure
Title
Angiographic binary in-stent restenosis (>= 50% diameter stenosis) rate at 6 months post-procedure
Time Frame
6 months post-procedure
Title
In-segment late lumen loss at 6 months
Time Frame
6 months post-procedure
Title
In-stent late lumen loss at 6 months
Time Frame
6 months post-procedure
Title
Device Success
Time Frame
6 months post-procedure
Title
Lesion Success
Time Frame
6 months post-procedure
Title
Procedure Success
Time Frame
6 months post-procedure
Title
Major Adverse Cardiac Events (MACE) rate at 30 days, 6 months, and 12 months post-procedure
Time Frame
30 days, 6 months and 12 months post-procedure
Title
Target Site Revascularization (TSR) rate and clinically-driven TSR rate at 6 and 12 months post-procedure Target Vessel Revascularization (TVR) rate and clinically-driven TVR rate at 6 and 12 months post-procedure
Time Frame
6 and 12 months post-procedure
Title
Target Vessel Failure (TVF) rate at 6 and 12 months post-procedure
Time Frame
6 and 12 months post-procedure
Title
In-stent and in-segment minimum lumen diameter (MLD) at 6 months post-procedure
Time Frame
6 months post-procedure
Title
Failure of sustained patency at 6 months (≥70% stenosis with TIMI <3 flow at follow-up angiography)
Time Frame
6 months post-procedure
Title
Subacute thrombosis occurring within 30 days post-procedure
Time Frame
30 days post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Rao, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Green Hospital of Scripps Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Scripps Memorial Hospital-La Jolla
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Saint Lukes Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
New York Presbyterian Medical
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
The Sanger Clinic PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
North Ohio Heart Center
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Heart Hospital of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Vancouver Hospital and Health Science Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Saint Michaels Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

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