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AzTrials

Coronary Artery DiseasePhase 3NCT00307047

SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

A Phase 3 study testing XIENCE V® Everolimus Eluting Coronary Stent and TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent in people with Coronary Artery Disease, run by Abbott Medical Devices at 65 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®). The XIENCE V® arm will be compared to an active control, represented by the FDA-approved TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent System… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
XIENCE V® Everolimus Eluting Coronary Stent and TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,687 participants
Where
65 sitesUnited States
Study dates
Aug 2006to May 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

General Inclusion Criteria:

  • Subject must be at least 18 years of age
  • Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving XIENCE V® and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
  • Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
  • Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
  • Subject must agree to undergo all protocol-required follow-up procedures
  • Subject must agree not to participate in any other clinical study for a period of one year following the index procedure

Angiographic Inclusion Criteria:

  • Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and treatment of up to a three de novo target lesions, maximum of two de novo target lesions per epicardical vessel. (NOTE: RVD ≥2.5 mm to ≤3.75 mm until 4.0 mm TAXUS® is commercially available)
  • Target lesion(s) must measure ≤28 mm in length by visual estimation(≥3 mm of non-diseased tissue on either side of the target lesion should be covered by the study stent)
  • If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria
  • If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria
  • The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1
  • Non-study, percutaneous intervention for lesions in a target vessel (including side branches) is allowed if done ≥ 9 months prior to the index procedure
  • Non-study percutaneous intervention for lesions in a non-target vessel involving:
  • Successful and uncomplicated (visually estimated diameter stenosis < 50%, TIMI Grade 3 flow, no ECG changes, prolonged chest pain, or angiographic complications) bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 24 hours prior to the index procedure or during (before randomization) the index procedure. For interventions done within 24 to 48 hours prior to the index procedure, CK and CK-MB must be assessed to be < 2 times the upper limit of normal at the time of the index procedure. NOTE: Procedures within the 24 hour period preceding the index procedure are not permitted
  • Unsuccessful or complicated bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 30 days prior to the index procedure
  • Drug-eluting stent treatment is allowed if done ≥ 90 days prior to the index procedure
  • Non-study, percutaneous interventions for lesion(s) in a target vessel (including side branches) or non-target vessel are allowed if done ≥ 9 months after the index procedure

General Exclusion Criteria:

  • Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure
  • The subject is currently experiencing clinical symptoms consistent with AMI
  • Subject has current unstable arrhythmias
  • Subject has a known left ventricular ejection fraction (LVEF) < 30%
  • Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
  • Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure
  • Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.)
  • Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
  • Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated
  • Elective surgery that will require discontinuing either aspirin or clopidogrel is planned within the first 9 months after the procedure
  • Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
  • Subject has known renal insufficiency (e.g., serum creatinine level of > 2.5 mg/dL or subject on dialysis)
  • Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
  • Subject has had a significant GI or urinary bleed within the past six months
  • Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
  • Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a life expectancy of less than one year
  • Subject is already participating in another clinical study that has not yet reached its primary endpoint
  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used up to 1 year following the index procedure)
  • Angiographic Exclusion Criteria
  • The target lesion(s) meets any of the following criteria:
  • Left main coronary artery location including left main ostial location (NOTE: RCA-aorto-ostial lesions are not excluded)
  • Located within 2 mm of the origin of the LAD or LCX
  • Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and any visually estimated diameter stenosis > 20%) arterial or saphenous vein graft
  • Involves a bifurcation in which the side branch is ≥ 2 mm in diameter AND the ostium of the side branch is > 50% stenosed by visual estimation
  • Involves a side branch requiring pre-dilatation
  • Total occlusion (TIMI flow 0) prior to wire crossing
  • Excessive tortuosity proximal to or within the lesion
  • Extreme angulation (≥ 90º) proximal to or within the lesion
  • Heavy calcification
  • Restenotic from previous intervention
  • Subject has received brachytherapy in any epicardial vessel (including side branches)
  • The target vessel contains thrombus
  • Another clinically significant lesion in the target vessel is present that requires or has a high probability of requiring PCI during the index procedure
  • Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 9 months after the index procedure

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

United States65 sites

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Bay Regional Medical Center

    Bay City, Michigan, 48706

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Millard Fillmore Hospital

    Buffalo, New York, 14209

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Presbyterian Hospital - Charlotte

    Charlotte, North Carolina, 28233

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Sisters of Charity Providence Hospitals

    Columbia, South Carolina, 29204

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48124

  • Iowa Heart Center P.C.

    Des Moines, Iowa, 50266

  • EMH Regional Medical Center

    Elyria, Ohio, 44035

  • Inova Fairfax Hospital

    Fairfax, California, 22031

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80528

  • Plaza Medical Center of Fort Worth

    Fort Worth, Texas, 76104

  • Spectrum Health Hospital

    Grand Rapids, Michigan, 49503

  • Pitt County Memorial Hospital

    Greenville, North Carolina, 27834

  • St. Francis Health System

    Greenville, South Carolina, 29605

  • St. Francis Hospital and Health Centers

    Indianapolis, Indiana, 46237

  • The Heart Center of Indiana

    Indianapolis, Indiana, 46290

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Research Medical Center

    Kansas City, Missouri, 64132

  • San Diego Cardiovascular Associates

    La Jolla, California, 92037

  • Scripps Memorial Hospital

    La Jolla, California, 92037

  • Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • Dartmouth Hitchock Medical Center

    Lebanon, New Hampshire, 03756

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Nebraska Heart Hospital

    Lincoln, Nebraska, 68526

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Good Samaritan Hospital - LA

    Los Angeles, California, 90017

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • St. Luke's Medical Center - Milwaukee

    Milwaukee, Wisconsin, 53215

  • St. Patrick Hospital

    Missoula, Montana, 59802

  • Vanderbilt Vniversity Medical Center

    Nashville, Tennessee, 37205

  • New York Presbyterian Hospital-Cornell

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

  • Sentara Norfolk General

    Norfolk, Virginia, 23507

  • Sacred Heart Hospital

    Pensacola, Florida, 32504-8721

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • The Valley Hospital

    Pomona, New York, 10970

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Wake Medical Center

    Raleigh, North Carolina, 27610

  • Mercy General Hospital

    Sacramento, California, 95819

  • Sutter Medical Center of Santa Rosa

    Santa Rosa, California, 95404-1797

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85260

  • Stony Brook Hospital and Medical Center

    Stony Brook, New York, 11794

  • St. Joseph's Hospital Health Center

    Syracuse, New York, 13203

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • St. Joseph Medical Center

    Towson, Maryland, 21204

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • Saint Vincent Hospital

    Worcester, Massachusetts, 01608

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®). The XIENCE V® arm will be compared to an active control, represented by the FDA-approved TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent System (TAXUS®), commercially available from Boston Scientific.

TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

Read the detailed description

The completion of the SPIRIT IV clinical trial at three years is justified by the consistent long-term clinical evidence supporting the safety and efficacy of the XIENCE V EECSS in complex, real-world patients across multiple geographies. As SPIRIT IV was designed as a continued access trial, completing the clinical follow-up at the three-year visit does not conflict with any FDA requirements. Abbott Vascular is committed to providing clinical outcomes through three years. The clinical evidence provided from across multiple geographies, in complex populations thus supports Abbott Vascular's proposal to complete the SPIRIT IV RCT at the three-year clinical follow-up.

The SPIRIT IV Clinical Trial is a randomized, active-controlled, single-blinded, multicenter clinical trial in the US that will enroll approximately 3,690 subjects (2:1 randomization XIENCE V®: TAXUS®). The trial allows the treatment of up to three de novo native coronary artery lesions, maximum of two lesion per epicardial vessel, with reference vessel diameters (RVD) ≥ 2.5 mm to ≤ 4.25 mm and lesion lengths ≤ 28 mm. (NOTE: RVD ≥ 2.5 mm to ≤ 3.75 mm until 4.0 mm TAXUS® is commercially available). All subjects will be screened per the protocol inclusion and exclusion criteria and enrolled subjects will have clinical follow-up at 30, 180, and 270 days and 1, 2, and 3 years.

Being tested
XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Keywords
Stents, Angioplasty, Total coronary occlusion, coronary restenosis, stent thrombosis
Medical subject headings
Coronary Artery Disease, Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XIENCE V® Everolimus Eluting Coronary StentDevice

    Also called XIENCE V® Everolimus Eluting Coronary Stent System

    Drug eluting stent implantation stent in the treatment of coronary artery disease.

  • TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary StentDevice

    Also called TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System

    Drug eluting stent implantation stent in the treatment of coronary artery disease.

Study groups in NCT00307047
Study groupRoleWhat they receive
XIENCE V®ExperimentalNot described
Receives: Device: XIENCE V® Everolimus Eluting Coronary Stent
TAXUS™ EXPRESS2™Active comparatorNot described
Receives: Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ischemia Driven Target Lesion Failure (TLF)

    Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

    Measured: 1 year

Secondary outcomes (65)

  1. Ischemia Driven Target Vessel Failure (TVF)

    Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

    Measured: 30 days

  2. Ischemia Driven Target Vessel Failure (TVF)

    Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

    Measured: 180 days

  3. Ischemia Driven Target Vessel Failure (TVF)

    Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

    Measured: 270 days

  4. Ischemia Driven Target Vessel Failure (TVF)

    Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

    Measured: 1 year

  5. Ischemia Driven Target Vessel Failure (TVF)

    Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

    Measured: 2 years

  6. Ischemia Driven Target Vessel Failure (TVF)

    Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

    Measured: 3 years

  7. Ischemia Driven Target Lesion Revascularization (TLR)

    Revascularization of a target lesion associated with any of the following:

    • positive functional ischemia study
    • ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

    Measured: 30 days

  8. Ischemia Driven Target Lesion Revascularization (TLR)

    Revascularization of a target lesion associated with any of the following:

    • positive functional ischemia study
    • ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

    Measured: 180 days

  9. Ischemia Driven Target Lesion Revascularization (TLR)

    Revascularization of a target lesion associated with any of the following:

    • positive functional ischemia study
    • ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

    Measured: 270 days

  10. Ischemia Driven Target Lesion Revascularization (TLR)

    Revascularization of a target lesion associated with any of the following:

    • positive functional ischemia study
    • ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

    Measured: 1 year

  11. Ischemia Driven Target Lesion Revascularization (TLR)

    Revascularization of a target lesion associated with any of the following:

    • positive functional ischemia study
    • ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

    Measured: 2 years

  12. Ischemia Driven Target Lesion Revascularization (TLR)

    Revascularization of a target lesion associated with any of the following:

    • positive functional ischemia study
    • ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

    Measured: 3 years

  13. Ischemia Driven Target Vessel Revascularization (TVR)

    Revascularization of a lesion within the target vessel associated with any of the following:

    • positive functional ischemia study
    • ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

    Measured: 30 days

  14. Ischemia Driven Target Vessel Revascularization (TVR)

    Revascularization of a lesion within the target vessel associated with any of the following:

    • positive functional ischemia study
    • ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

    Measured: 180 days

  15. Ischemia Driven Target Vessel Revascularization (TVR)

    Revascularization of a lesion within the target vessel associated with any of the following:

    • positive functional ischemia study
    • ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

    Measured: 270 days

  16. Ischemia Driven Target Vessel Revascularization (TVR)

    Revascularization of a lesion within the target vessel associated with any of the following:

    • positive functional ischemia study
    • ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

    Measured: 1 year

  17. Ischemia Driven Target Vessel Revascularization (TVR)

    Revascularization of a lesion within the target vessel associated with any of the following:

    • positive functional ischemia study
    • ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

    Measured: 2 years

  18. Ischemia Driven Target Vessel Revascularization (TVR)

    Revascularization of a lesion within the target vessel associated with any of the following:

    • positive functional ischemia study
    • ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

    Measured: 3 years

  19. Ischemia Driven Major Adverse Cardiac Events (MACE)

    Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

    Measured: 30 days

  20. Ischemia Driven Major Adverse Cardiac Events (MACE)

    Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

    Measured: 180 days

  21. Ischemia Driven Major Adverse Cardiac Events (MACE)

    Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

    Measured: 270 days

  22. Ischemia Driven Major Adverse Cardiac Events (MACE)

    Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

    Measured: 1 years

  23. Ischemia Driven Major Adverse Cardiac Events (MACE)

    Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

    Measured: 2 years

  24. Ischemia Driven Major Adverse Cardiac Events (MACE)

    Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

    Measured: 3 years

  25. Acute Success (Clinical Device)

    Successful delivery and deployment of the first implanted study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stents) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Bailout subjects will be included as device success only if the above criteria for clinical device are met.

    Measured: Acute: At time of index procedure

  26. Acute Success (Clinical Procedure)

    Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days following the index procedure. In multiple lesion setting all lesions must meet clinical procedure success.

    Measured: Acute: At time of index procedure

  27. All Myocardial Infarction (MI)

    Measured: 30 days

  28. All MI

    Measured: 180 days

  29. All MI

    Measured: 270 days

  30. All MI

    Measured: 1 year

  31. All MI

    Measured: 2 years

  32. All MI

    Measured: 3 years

  33. All Cause Mortality

    Measured: 30 days

  34. All Cause Mortality

    Measured: 180 days

  35. All Cause Mortality

    Measured: 270 days

  36. All Cause Mortality

    Measured: 1 year

  37. All Cause Mortality

    Measured: 2 years

  38. All Cause Mortality

    Measured: 3 years

  39. Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

    Measured: 30 days

  40. Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

    Measured: 180 days

  41. Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

    Measured: 270 days

  42. Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

    Measured: 1 year

  43. Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

    Measured: 2 years

  44. Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)

    Measured: 3 years

  45. Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition

    ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post

    • Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

    † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

    Measured: 0-30 days

  46. Definite + Probable Stent Thrombosis Rate Based on ARC Definition

    ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post

    • Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

    † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

    Measured: 31-393 days

  47. Definite + Probable Stent Thrombosis Rate Based on ARC Definition

    ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post

    • Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

    † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

    Measured: 0 -393 days

  48. Definite + Probable Stent Thrombosis Rate Based on ARC Definition

    ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post

    • Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

    † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

    Measured: 0-758 days

  49. Definite + Probable Stent Thrombosis Rate Based on ARC Definition

    ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post

    • Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

    † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

    Measured: 0-1123 days

  50. Protocol Defined Stent Thrombosis Rate

    ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

    • Clinical presentation of acute coronary syndrome with angiographic evidence of ST
    • In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

    Measured: 0-30 days

  51. Protocol Defined Stent Thrombosis Rate

    ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

    • Clinical presentation of acute coronary syndrome with angiographic evidence of ST
    • In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

    Measured: 31-393 days

  52. Protocol Defined Stent Thrombosis Rate

    ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

    • Clinical presentation of acute coronary syndrome with angiographic evidence of ST
    • In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

    Measured: 0-393 days

  53. Protocol Defined Stent Thrombosis Rate

    ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

    • Clinical presentation of acute coronary syndrome with angiographic evidence of ST
    • In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

    Measured: 0-758 days

  54. Protocol Defined Stent Thrombosis Rate

    ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

    • Clinical presentation of acute coronary syndrome with angiographic evidence of ST
    • In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

    Measured: 0-1123 days

  55. Cardiac Death or Target Vessel MI Rate

    Measured: 30 days

  56. Cardiac Death or Target Vessel MI Rate

    Measured: 180 days

  57. Cardiac Death or Target Vessel MI Rate

    Measured: 270 days

  58. Cardiac Death or Target Vessel MI Rate

    Measured: 1 year

  59. Cardiac Death or Target Vessel MI Rate

    Measured: 2 years

  60. Cardiac Death or Target Vessel MI Rate

    Measured: 3 years

  61. Ischemia Driven Target Lesion Failure (TLF)

    Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

    Measured: 30 days

  62. Ischemia Driven Target Lesion Failure (TLF)

    Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

    Measured: 180 days

  63. Ischemia Driven Target Lesion Failure (TLF)

    Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

    Measured: 270 days

  64. Ischemia Driven Target Lesion Failure (TLF)

    Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

    Measured: 2 years

  65. Ischemia Driven Target Lesion Failure (TLF)

    Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionAug 2009
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
3,687 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00307047
Sponsor's protocol ID
05-368
Status last verified
Oct 2012
First submitted
23 Mar 2006
Last updated
7 Nov 2012
Data monitoring committee
Yes

Publications

  • Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.

    PubMed 25940520

  • Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.

    PubMed 24746650

  • Pervaiz MH, Sood P, Sudhir K, Hermiller JB, Hou L, Hattori K, Su X, Cao S, Wang J, Applegate RJ, Kereiakes DJ, Yaqub M, Stone GW, Cutlip DE. Periprocedural myocardial infarction in a randomized trial of everolimus-eluting and Paclitaxel-eluting coronary stents: frequency and impact on mortality according to historic versus universal definitions. Circ Cardiovasc Interv. 2012 Apr;5(2):150-6. doi: 10.1161/CIRCINTERVENTIONS.111.965566. Epub 2012 Mar 20.

    PubMed 22438430

  • Claessen BE, Smits PC, Kereiakes DJ, Parise H, Fahy M, Kedhi E, Serruys PW, Lansky AJ, Cristea E, Sudhir K, Sood P, Simonton CA, Stone GW. Impact of lesion length and vessel size on clinical outcomes after percutaneous coronary intervention with everolimus- versus paclitaxel-eluting stents pooled analysis from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials. JACC Cardiovasc Interv. 2011 Nov;4(11):1209-15. doi: 10.1016/j.jcin.2011.07.016.

    PubMed 22115661

  • Planer D, Smits PC, Kereiakes DJ, Kedhi E, Fahy M, Xu K, Serruys PW, Stone GW. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials. JACC Cardiovasc Interv. 2011 Oct;4(10):1104-15. doi: 10.1016/j.jcin.2011.06.018.

    PubMed 22017936

  • Kereiakes DJ, Sudhir K, Hermiller JB, Gordon PC, Ferguson J, Yaqub M, Sood P, Su X, Yakubov S, Lansky AJ, Stone GW. Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients undergoing multilesion and multivessel intervention: the SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials. JACC Cardiovasc Interv. 2010 Dec;3(12):1229-39. doi: 10.1016/j.jcin.2010.09.014.

    PubMed 21232716

  • Kereiakes DJ, Cutlip DE, Applegate RJ, Wang J, Yaqub M, Sood P, Su X, Su G, Farhat N, Rizvi A, Simonton CA, Sudhir K, Stone GW. Outcomes in diabetic and nondiabetic patients treated with everolimus- or paclitaxel-eluting stents: results from the SPIRIT IV clinical trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System). J Am Coll Cardiol. 2010 Dec 14;56(25):2084-9. doi: 10.1016/j.jacc.2010.10.006.

    PubMed 21144968

  • Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010 May 6;362(18):1663-74. doi: 10.1056/NEJMoa0910496.

    PubMed 20445180

  • Nikolsky E, Lansky AJ, Sudhir K, Doostzadeh J, Cutlip DE, Piana R, Su X, White R, Simonton CA, Stone GW. SPIRIT IV trial design: a large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease. Am Heart J. 2009 Oct;158(4):520-526.e2. doi: 10.1016/j.ahj.2009.07.025. Epub 2009 Aug 26.

    PubMed 19781409

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XIENCE V® Everolimus Eluting Coronary Stent and TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent in people with Coronary Artery Disease, run by Abbott Medical Devices at 65 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ischemia Driven Target Lesion Failure (TLF) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00307047, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2012.

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