Coronary Artery Disease Clinical Trial
— ARRIVEOfficial title:
TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program
The TAXUS ARRIVE study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical practice and to identify low frequency TAXUS related clinical events.
| Status | Completed |
| Enrollment | 2585 |
| Est. completion date | April 2007 |
| Est. primary completion date | April 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Appropriate Patient Criteria: - Patient is eligible to receive a Boston Scientific TAXUS Stent. Inappropriate Patients Criteria: - Known sensitivity to paclitaxel. - Known allergy to stainless steel. - Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated. - Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device. - Patients with unresolved vessel thrombus at the lesion site. - Patients with coronary artery reference vessel diameters < 2.5 mm or > 3.75 mm. - Patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation. - Patients with diffuse disease or poor overflow distal to the identified lesions. - Patients with tortuous vessels in the region of the obstruction or proximal to the lesion. - Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow. |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Abington Memorial Hospital | Abington | Pennsylvania |
| United States | Asheville Cardiology Associates, PA | Asheville | North Carolina |
| United States | Northeast Cardiology Associates | Bangor | Maine |
| United States | Hope Heart Institute | Bellevue | Washington |
| United States | Aultman Hospital | Canton | Ohio |
| United States | Mid-Carolina Cardiology Presbyterian Hospital | Charlotte | North Carolina |
| United States | Metro Cardiology Consultants | Coon Rapids | Minnesota |
| United States | Methodist Dallas Medical Center | Dallas | Texas |
| United States | Genesis Medical Center | Davenport | Iowa |
| United States | Alexian Brothers Medical Center | Elk Grove | Illinois |
| United States | Cleveland Cardiovascular Research Foundation | Fairview Park | Ohio |
| United States | INOVA Fairfax Hospital | Falls Church | Virginia |
| United States | Poudre Valley Hospital | Fort Collins | Colorado |
| United States | Lutheran Hospital/NIRA | Fort Wayne | Indiana |
| United States | Advanced Cardiac Specialists | Gilbert | Arizona |
| United States | Regional Cardiology Associates | Grand Blanc | Michigan |
| United States | Greenville Hospital Systems | Greenville | South Carolina |
| United States | Pitt County Memorial Hospital | Greenville | North Carolina |
| United States | Hartford Hospital | Hartford | Connecticut |
| United States | St Mary's Hospital | Huntington | West Virginia |
| United States | St Francis Hospital | Indianapolis | Indiana |
| United States | Cardiology Associates of NEA | Jonesboro | Arkansas |
| United States | Advanced Clinical Research Group, LLC | Juniper | Florida |
| United States | Research Medical Center | Kansas City | Missouri |
| United States | Cardiovascular Associates, PC | Kingsport | Tennessee |
| United States | Our Lady of Lourdes | Lafayette | Louisiana |
| United States | Cardiovascular Consultants of Nevada | Las Vegas | Nevada |
| United States | Texas Cardiac Center | Lubbock | Texas |
| United States | Georgia Heart and Vascular Center | Macon | Georgia |
| United States | Morristown Memorial | Morristown | New Jersey |
| United States | St. Peters Hospital | Olympia | Washington |
| United States | Florida Heart Institute | Orlando | Florida |
| United States | Presbyterian University of Pennsylvania Medical Center | Philadelphia | Pennsylvania |
| United States | Maine Medical Center | Portland | Maine |
| United States | WakeMed - Wake Heart Associates | Raleigh | North Carolina |
| United States | University of California Davis Medical Center | Sacramento | California |
| United States | Salinas Valley Memorial Hospital | Salinas | California |
| United States | Delmarva Heart Research Foundation, Inc | Salisbury | Maryland |
| United States | LDS Hospital | Salt Lake City | Utah |
| United States | South Texas Cardiovascular Consultants | San Antonio | Texas |
| United States | Good Samaritan | San Jose | California |
| United States | Willis Knighton Medical Center | Shreveport | Louisiana |
| United States | Avera Heart Hospital of South Dakota | Sioux Falls | South Dakota |
| United States | Washington University School of Medicine | St. Louis | Missouri |
| United States | Tallahassee Memorial Hospital | Tallahassee | Florida |
| United States | Little Company of Mary Hospital | Torrance | California |
| United States | Trinity Mother Frances Hospital | Tyler | Texas |
| United States | Westchester County Medical Center | Valhalla | New York |
| United States | Care Foundation, Inc. | Wausau | Wisconsin |
| United States | Clear Lake Regional Medical Center | Webster | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Scientific Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of TAXUS stent related cardiac events at a 1-year post implant procedure as classified by the Clinical Events Committee | 1 year post-implant procedure | Yes | |
| Secondary | Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee | 30 days, 6 months, 2 years post-implant procedure | Yes | |
| Secondary | Rate of target vessel related cardiac events as classified by the Clinical Events Committee | 30 days, 6 months, 1 and 2 years post-implant procedure | Yes | |
| Secondary | Rate of other TAXUS related events | 30 days, 6 months, 1 and 2 years post-implant procedure | Yes |
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