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

NCT00307047 | Completed Phase 3 Results DMC

• 1 other identifier: 05-368
• Study Type: interventional
• Target: 3,687
• Locations: 1 country
• Sites: 65

Brief 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 (TAXUS®), commercially available from Boston Scientific. TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

Conditions

Coronary Artery Disease

Keywords

Stents; Angioplasty; Total coronary occlusion; coronary restenosis; stent thrombosis

Outcome Measures

Primary Outcomes (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).

  1 year

Secondary Outcomes (65)

• Ischemia Driven Target Vessel Failure (TVF)

  30 days

• Ischemia Driven Target Vessel Failure (TVF)

  180 days

• Ischemia Driven Target Vessel Failure (TVF)

  270 days

• Ischemia Driven Target Vessel Failure (TVF)

  1 year

• Ischemia Driven Target Vessel Failure (TVF)

  2 years

Study Arms (2)

XIENCE V®

EXPERIMENTAL

Device: XIENCE V® Everolimus Eluting Coronary Stent

TAXUS™ EXPRESS2™

ACTIVE COMPARATOR

Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

Interventions

XIENCE V® Everolimus Eluting Coronary Stent DEVICE

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

Also known as: XIENCE V® Everolimus Eluting Coronary Stent System

XIENCE V®

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent DEVICE

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

Also known as: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System

TAXUS™ EXPRESS2™

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (65)

Scottsdale Healthcare

Scottsdale, Arizona, 85260, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Inova Fairfax Hospital

Fairfax, California, 22031, United States

Location

San Diego Cardiovascular Associates

La Jolla, California, 92037, United States

Location

Scripps Memorial Hospital

La Jolla, California, 92037, United States

Location

Good Samaritan Hospital - LA

Los Angeles, California, 90017, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Sutter Medical Center of Santa Rosa

Santa Rosa, California, 95404-1797, United States

Location

The Medical Center of Aurora

Aurora, Colorado, 80012, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80528, United States

Location

Washington Hospital Center

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

Location

Sacred Heart Hospital

Pensacola, Florida, 32504-8721, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

St. Francis Hospital and Health Centers

Indianapolis, Indiana, 46237, United States

Location

The Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

Location

Iowa Heart Center P.C.

Des Moines, Iowa, 50266, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

St. Joseph Medical Center

Towson, Maryland, 21204, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Saint Vincent Hospital

Worcester, Massachusetts, 01608, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Bay Regional Medical Center

Bay City, Michigan, 48706, United States

Location

Oakwood Hospital and Medical Center

Dearborn, Michigan, 48124, United States

Location

Spectrum Health Hospital

Grand Rapids, Michigan, 49503, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49048, United States

Location

Ingham Regional Medical Center

Lansing, Michigan, 48910, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

St. Patrick Hospital

Missoula, Montana, 59802, United States

Location

Nebraska Heart Hospital

Lincoln, Nebraska, 68526, United States

Location

Dartmouth Hitchock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Millard Fillmore Hospital

Buffalo, New York, 14209, United States

Location

New York Presbyterian Hospital-Cornell

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

The Valley Hospital

Pomona, New York, 10970, United States

Location

Stony Brook Hospital and Medical Center

Stony Brook, New York, 11794, United States

Location

St. Joseph's Hospital Health Center

Syracuse, New York, 13203, United States

Location

Presbyterian Hospital - Charlotte

Charlotte, North Carolina, 28233, United States

Location

Pitt County Memorial Hospital

Greenville, North Carolina, 27834, United States

Location

Wake Medical Center

Raleigh, North Carolina, 27610, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

EMH Regional Medical Center

Elyria, Ohio, 44035, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Sisters of Charity Providence Hospitals

Columbia, South Carolina, 29204, United States

Location

St. Francis Health System

Greenville, South Carolina, 29605, United States

Location

Vanderbilt Vniversity Medical Center

Nashville, Tennessee, 37205, United States

Location

Plaza Medical Center of Fort Worth

Fort Worth, Texas, 76104, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Sentara Norfolk General

Norfolk, Virginia, 23507, United States

Location

St. Luke's Medical Center - Milwaukee

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (9)

• 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.

  PMID: 25940520 DERIVED

• 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.

  PMID: 24746650 DERIVED

• 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.

  PMID: 22438430 DERIVED

• 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.

  PMID: 22115661 DERIVED

• 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.

  PMID: 22017936 DERIVED

• 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.

  PMID: 21232716 DERIVED

• 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.

  PMID: 21144968 DERIVED

• 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.

  PMID: 20445180 DERIVED

• 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.

  PMID: 19781409 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Stenosis

Results Point of Contact

• Title: Ellen Travis
• Organization: Abbott Vascular

ellen.travis@av.abbott.com

408-845-1512

Study Officials

• Gregg W Stone

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2006
• First Posted: March 27, 2006
• Study Start: August 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: May 1, 2012
• Last Updated: November 7, 2012
• Results First Posted: October 21, 2010

Record last verified: 2012-10

Locations

US (65)