SPIRIT PRIME Clinical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00916370
First received: June 5, 2009
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due to a maximum of two de novo native coronary artery lesions, each in a different epicardial vessel.


Condition Intervention Phase
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Device: Core size Xience Prime
Device: Xience Prime Long Lesion (LL)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SPIRIT PRIME Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Target Lesion Failure (TLF) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    The composite rate of:

    Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.



Secondary Outcome Measures:
  • Procedure Time [ Time Frame: From insertion to withdrawal of guide catheter ] [ Designated as safety issue: Yes ]
    Procedure time is defined as time between insertion and withdrawal of guide catheter.

  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: In-hospital is less than or equal to 7 days post index procedure ] [ Designated as safety issue: Yes ]
  • Target Vessel-Myocardial Infarction (TV-MI)Per Protocol - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure. ] [ Designated as safety issue: Yes ]
    Per Protocol

  • Non-target Vessel MI (Q-wave, Non Q-wave) [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ] [ Designated as safety issue: Yes ]
    Per Protocol

  • Clinically Indicated-Target Lesion Revascularization [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ] [ Designated as safety issue: No ]
  • Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ] [ Designated as safety issue: No ]
  • All TLR (CI and Non-CI) [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ] [ Designated as safety issue: No ]
  • All TVR (CI and Non-CI) [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ] [ Designated as safety issue: No ]
  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ] [ Designated as safety issue: No ]
  • Cardiac Death/All MI [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ] [ Designated as safety issue: Yes ]
  • Cardiac Death/ All MI/CI-TLR [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]
  • All Death/All MI/All Coronary Revascularization [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ] [ Designated as safety issue: Yes ]
    Per Protocol Definition

  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Per Protocol

  • Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Per Protocol

  • Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Per Protocol

  • Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Device Success (Lesion Basis) [ Time Frame: From the start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).

  • Procedural Success (Subject Basis) [ Time Frame: From the start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA). Per Protocol.

  • Non-target Vessel MI (Q-wave, Non Q-wave) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Per Protocol

  • Non-target Vessel MI (Q-wave, Non Q-wave) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Per Protocol

  • Non-target Vessel MI (Q-wave, Non Q-wave) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Per Protocol

  • Non-target Vessel MI (Q-wave, Non Q-wave) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Non-target Vessel MI (Q-wave, Non Q-wave) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Non-target Vessel MI (Q-wave, Non Q-wave) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Non-target Vessel MI (Q-wave, Non Q-wave) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Clinically Indicated-Target Lesion Revascularization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Clinically Indicated-Target Lesion Revascularization [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Clinically Indicated-Target Lesion Revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Clinically Indicated-Target Lesion Revascularization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Clinically Indicated-Target Lesion Revascularization [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Clinically Indicated-Target Lesion Revascularization [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Clinically Indicated-Target Lesion Revascularization [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • All TLR (CI and Non-CI) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All TLR (CI and Non-CI) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • All TLR (CI and Non-CI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • All TLR (CI and Non-CI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • All TLR (CI and Non-CI) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • All TLR (CI and Non-CI) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • All TLR (CI and Non-CI) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • All TVR (CI and Non-CI) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All TVR (CI and Non-CI) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • All TVR (CI and Non-CI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • All TVR (CI and Non-CI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • All TVR (CI and Non-CI) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • All TVR (CI and Non-CI) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • All TVR (CI and Non-CI) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Cardiac Death/ All MI [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Per Protocol

  • Cardiac Death/All MI [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Per Protocol

  • Cardiac Death/All MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Per Protocol

  • Cardiac Death/All MI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/ All MI/CI-TLR [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Per Protocol Definition

  • Cardiac Death/ All MI/CI-TLR [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Per Protocol Definition

  • Cardiac Death/ All MI/CI-TLR [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Per Protocol Definition

  • Cardiac Death/ All MI/CI-TLR [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/ All MI/CI-TLR [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/ All MI/CI-TLR [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/ All MI/CI-TLR [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • All Death/ All MI/All Coronary Revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • All Death/ All MI/All Coronary Revascularization [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • All Death/ All MI/All Coronary Revascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • All Death/ All MI/All Coronary Revascularization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • All Death/ All MI/All Coronary Revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • All Death/ All MI/All Coronary Revascularization [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • All Death/ All MI/All Coronary Revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per Protocol and Per ARC) [ Time Frame: Acute (≤1 day) ] [ Designated as safety issue: Yes ]
    Definite and Probable

  • Stent Thrombosis (Per Protocol and Per ARC) [ Time Frame: Subacute (>1 - 30 days) ] [ Designated as safety issue: Yes ]
    Definite and Probable

  • Stent Thrombosis (Per Protocol and Per ARC) [ Time Frame: Acute/Subacute (0 - 30 days) ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per Protocol and Per ARC) [ Time Frame: Late (31 - 393 days) ] [ Designated as safety issue: Yes ]
    Definite and Probable

  • Stent Thrombosis (Per Protocol and Per ARC) [ Time Frame: Overall (0-393 days) ] [ Designated as safety issue: Yes ]
    Definite and Probable


Enrollment: 505
Study Start Date: June 2009
Study Completion Date: February 2014
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Core size registry
Core size indicates the range of diameters of the stents used.
Device: Core size Xience Prime
Core size includes a range of stent sizes.
Experimental: Long lesion registry
Use of long lesion stents.
Device: Xience Prime Long Lesion (LL)
Long lesion stent sizes include a range of sizes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must be at least 18 years of age.
  2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
  3. 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).
  4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  5. Subject must agree to undergo all protocol-required follow-up procedures.
  6. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

  1. One or two de novo target lesions each in a different epicardial vessel.
  2. If there are two target lesions, both lesions must satisfy the angiographic eligibility criteria for that registry.

    o Multiple focal de novo lesions in a target vessel that can be covered by a single stent are allowed.

  3. The target lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.
  4. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of:

    • ≥ 2.25 mm and ≤ 4.25 mm for treatment by the core size XIENCE PRIME EECS
    • ≥ 2.5 mm and ≤ 4.25 mm for treatment by the XIENCE PRIME LL EECS
  5. Target lesion(s) must be located in a native coronary artery with length by visual estimation of:

    • ≤ 22 mm for treatment by the core size XIENCE PRIME EECS
    • > 22 mm and ≤ 32 mm for treatment by the XIENCE PRIME LL EECS

Exclusion Criteria:

  1. 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 to within normal limits at the time of procedure.
  2. The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
  3. Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
  4. Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
  5. Subject has received coronary brachytherapy in any epicardial vessel (target or non target).
  6. Subject has received any organ transplant or is on a waiting list for any organ transplant.
  7. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
  8. Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.
  9. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).
  10. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
  11. Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.
  12. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  13. Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel.
  14. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
  15. Subject has known renal insufficiency (examples being but not limited to estimated glomerular filtration rate (eGFR) < 60 ml/kg/m2, serum creatinine level ≥ 2.5 mg/dL, or on dialysis).
  16. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  17. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
  18. Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.
  19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
  20. 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 limited life expectancy (i.e., less than one year).
  21. Subject is currently participating in another clinical study that has not yet completed its primary endpoint.
  22. 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 per site standard test.

Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.

  1. Target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or saphenous vein graft.
  2. Target lesion involving a bifurcation with a side branch ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guide wire, or side branch requiring dilatation.
  3. Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.
  4. Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion.
  5. Restenotic target lesion.
  6. Aorto-ostial target lesion (within 3 mm of the aorta junction).
  7. Target lesion is in a left main location.
  8. Target lesion located within 2 mm of the origin of the LAD or LCX.
  9. Extreme angulation (≥ 90 °) or excessive tortuosity (≥ two 45° angles) proximal to or within the lesion.
  10. Heavy calcification proximal to or within the target lesion.
  11. Target vessel contains thrombus as indicated in the angiographic images.
  12. Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon).
  13. Target vessel is previously treated with any type of PCI (e.g. balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure.
  14. Non-target vessel is previously treated with any type of PCI < 90 days prior to the index procedure.
  15. Additional clinically significant lesion(s) (e.g. %DS ≥ 50%) in a target vessel or side branch for which PCI may be required < 90 days after the index procedure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916370

  Hide Study Locations
Locations
United States, Alabama
Thomas Hospital
Fairhope, Alabama, United States, 36532
United States, Arizona
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85260
United States, California
Mercy General Hospital
Sacramento, California, United States, 95819
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Morton Plant Hospital
Clearwater, Florida, United States, 33765
St. Vincents Medical Center
Jacksonville, Florida, United States, 32204
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
Sacred Heart Hospital of Pensicola
Pensacola, Florida, United States, 32504-8721
United States, Illinois
St. John's Hospital
Springfield, Illinois, United States, 62701
United States, Indiana
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States, 46260
United States, Iowa
Iowa Heart Center P.C.
West Des Moines, Iowa, United States, 50314
United States, Kansas
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
United States, Louisiana
Willis Knighton Health System, Pierremont
Shreveport, Louisiana, United States, 71105
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
United States, Massachusetts
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
United States, Michigan
Bay Regional Medical Center
Bay City, Michigan, United States, 48706
Borgess Medical Center
Kalamazoo, Michigan, United States, 49048
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, Montana
St. Patrick Hospital
Missoula, Montana, United States, 59802
United States, New Jersey
Cooper Health System
Camden, New Jersey, United States, 08103
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
United States, New York
Gotham Cardiology
New York, New York, United States, 10011
Mount Sinai Medical Center
NY, New York, United States, 10029
United States, North Carolina
Presbyterian Hospital - Charlotte
Charlotte, North Carolina, United States, 28233
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
EMH Regional Medical Center
Elyria, Ohio, United States, 44035
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
United States, Oklahoma
Hillcrest Medical Center
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Pinnacle Health @ Harrisburg Hospital
Harrisburg, Pennsylvania, United States, 17043
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
AnMed Health
Anderson, South Carolina, United States, 29621
United States, South Dakota
Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37660
United States, Texas
Northwest Texas Healthcare System
Amarillo, Texas, United States, 79106
Heart Hospital of Austin
Austin, Texas, United States, 78756
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
The Methodist Hospital
Pearland, Texas, United States, 77581
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, Washington
Overlake Hospital Medical Center
Bellevue, Washington, United States, 98004
St. Joseph Hospital
Bellingham, Washington, United States, 98225
Heart Clinics Northwest/ Sacred Heart Medical Center
Spokane, Washington, United States, 99204
United States, Wisconsin
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Australia, Queensland
Wesley Hospital
Auchenflower, Queensland, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia, 4061
Australia, Victoria
Monash Heart
Clayton, Victoria, Australia, 3168
St. Vincent's Hospital
Melbourne, Victoria, Australia, 3065
Epworth Hospital
Richmond, Victoria, Australia, 3121
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Marco Costa, MD, PhD University Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00916370     History of Changes
Other Study ID Numbers: 06-373
Study First Received: June 5, 2009
Results First Received: May 1, 2012
Last Updated: April 24, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Abbott Vascular:
drug eluting stents
stents
Angioplasty
myocardial ischemia
coronary artery stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Long lesion

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Coronary Stenosis
Coronary Restenosis
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014