SPIRIT PRIME Clinical Trial

NCT ID: NCT00916370

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 525 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2014-02-28

Brief Summary

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.

Conditions

Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Core size registry (CSR)

Core size indicates the range of diameters of the stents used.

Group Type: EXPERIMENTAL

Core size Xience Prime

Intervention Type: DEVICE

Core size includes a range of stent sizes.

Long lesion registry (LLR)

Use of long lesion stents.

Group Type: EXPERIMENTAL

Xience Prime Long Lesion (LL)

Intervention Type: DEVICE

Long lesion stent sizes include a range of sizes.

Interventions

Core size Xience Prime

Core size includes a range of stent sizes.

Intervention Type: DEVICE

Xience Prime Long Lesion (LL)

Long lesion stent sizes include a range of sizes.

Intervention Type: DEVICE

Eligibility 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.

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Costa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

Thomas Hospital

Fairhope, Alabama, United States

Scottsdale Healthcare

Scottsdale, Arizona, United States

Mercy General Hospital

Sacramento, California, United States

Washington Hospital Center

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

Morton Plant Hospital

Clearwater, Florida, United States

St. Vincents Medical Center

Jacksonville, Florida, United States

Orlando Regional Medical Center

Orlando, Florida, United States

Sacred Heart Hospital of Pensicola

Pensacola, Florida, United States

St. John's Hospital

Springfield, Illinois, United States

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, United States

Iowa Heart Center P.C.

West Des Moines, Iowa, United States

University of Kansas Hospital

Kansas City, Kansas, United States

Willis Knighton Health System, Pierremont

Shreveport, Louisiana, United States

Union Memorial Hospital

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Peninsula Regional Medical Center

Salisbury, Maryland, United States

Washington Adventist Hospital

Takoma Park, Maryland, United States

Cape Cod Hospital

Hyannis, Massachusetts, United States

Bay Regional Medical Center

Bay City, Michigan, United States

Borgess Medical Center

Kalamazoo, Michigan, United States

Northern Michigan Hospital

Petoskey, Michigan, United States

Beaumont Hospital

Royal Oak, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

St. Luke's Hospital

Kansas City, Missouri, United States

Barnes Jewish Hospital

St Louis, Missouri, United States

St. Patrick Hospital

Missoula, Montana, United States

Cooper Health System

Camden, New Jersey, United States

The Valley Hospital

Ridgewood, New Jersey, United States

Gotham Cardiology

New York, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Presbyterian Hospital - Charlotte

Charlotte, North Carolina, United States

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

University Hospitals of Cleveland

Cleveland, Ohio, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

EMH Regional Medical Center

Elyria, Ohio, United States

St. Vincent Mercy Medical Center

Toledo, Ohio, United States

Hillcrest Medical Center

Tulsa, Oklahoma, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Pinnacle Health @ Harrisburg Hospital

Harrisburg, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

AnMed Health

Anderson, South Carolina, United States

Sanford USD Medical Center

Sioux Falls, South Dakota, United States

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

Northwest Texas Healthcare System

Amarillo, Texas, United States

Heart Hospital of Austin

Austin, Texas, United States

St. Luke's Episcopal Hospital

Houston, Texas, United States

The Methodist Hospital

Pearland, Texas, United States

Fletcher Allen Health Care

Burlington, Vermont, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Overlake Hospital Medical Center

Bellevue, Washington, United States

St. Joseph Hospital

Bellingham, Washington, United States

Heart Clinics Northwest/ Sacred Heart Medical Center

Spokane, Washington, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Wesley Hospital

Auchenflower, Queensland, Australia

The Prince Charles Hospital

Chermside, Queensland, Australia

Monash Heart

Clayton, Victoria, Australia

St. Vincent's Hospital

Melbourne, Victoria, Australia

Epworth Hospital

Richmond, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Countries

United States; Australia

Other Identifiers

06-373

Identifier Type: -

Identifier Source: org_study_id