SPIRIT PRIME Clinical Trial

NCT00916370 | Completed Phase 3 Results DMC

• 1 other identifier: 06-373
• Study Type: interventional
• Target: 525
• Locations: 2 countries
• Sites: 62

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

Keywords

drug eluting stents; stents; Angioplasty; myocardial ischemia; coronary artery stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Long lesion

Outcome Measures

Primary Outcomes (3)

• Target Lesion Failure (TLF)

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

  1 year

• Target Lesion Failure (TLF)

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

  2 years

• Target Lesion Failure (TLF)

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

  3 years

Secondary Outcomes (82)

• Procedure Time

  From insertion to withdrawal of guide catheter

• Device Success (Lesion Basis)

  From the start of index procedure to end of index procedure

• Procedural Success (Subject Basis)

  From the start of index procedure to end of index procedure

• All Death (Cardiac, Vascular, Non-cardiovascular)

  In-hospital is less than or equal to 7 days post index procedure

• All Death (Cardiac, Vascular, Non-cardiovascular)

  30 days

Study Arms (2)

Core size registry (CSR)

EXPERIMENTAL

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

Device: Core size Xience Prime

Long lesion registry (LLR)

EXPERIMENTAL

Use of long lesion stents.

Device: Xience Prime Long Lesion (LL)

Interventions

Core size Xience Prime DEVICE

Core size includes a range of stent sizes.

Core size registry (CSR)

Xience Prime Long Lesion (LL) DEVICE

Long lesion stent sizes include a range of sizes.

Long lesion registry (LLR)

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 or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
• 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.
• One or two de novo target lesions each in a different epicardial vessel.
• 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.
• 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.
• 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
• 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

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 to within normal limits at the time of procedure.
• The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
• Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
• 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).
• Subject has received coronary brachytherapy in any epicardial vessel (target or non target).
• Subject has received any organ transplant or is on a waiting list for any organ transplant.
• Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
• Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.
• Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).
• Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
• Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.
• 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.
• Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel.
• 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).
• 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).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (62)

Thomas Hospital

Fairhope, Alabama, 36532, United States

Location

Scottsdale Healthcare

Scottsdale, Arizona, 85260, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Washington Hospital Center

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

Location

Morton Plant Hospital

Clearwater, Florida, 33765, United States

Location

St. Vincents Medical Center

Jacksonville, Florida, 32204, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Sacred Heart Hospital of Pensicola

Pensacola, Florida, 32504-8721, United States

Location

St. John's Hospital

Springfield, Illinois, 62701, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46260, United States

Location

Iowa Heart Center P.C.

West Des Moines, Iowa, 50314, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Willis Knighton Health System, Pierremont

Shreveport, Louisiana, 71105, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Peninsula Regional Medical Center

Salisbury, Maryland, 21801, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States

Location

Bay Regional Medical Center

Bay City, Michigan, 48706, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49048, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

St. Patrick Hospital

Missoula, Montana, 59802, United States

Location

Cooper Health System

Camden, New Jersey, 08103, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Gotham Cardiology

New York, New York, 10011, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Presbyterian Hospital - Charlotte

Charlotte, North Carolina, 28233, 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

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

EMH Regional Medical Center

Elyria, Ohio, 44035, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Hillcrest Medical Center

Tulsa, Oklahoma, 74104, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Pinnacle Health @ Harrisburg Hospital

Harrisburg, Pennsylvania, 17043, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

AnMed Health

Anderson, South Carolina, 29621, United States

Location

Sanford USD Medical Center

Sioux Falls, South Dakota, 57104, United States

Location

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Northwest Texas Healthcare System

Amarillo, Texas, 79106, United States

Location

Heart Hospital of Austin

Austin, Texas, 78756, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Pearland, Texas, 77581, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Overlake Hospital Medical Center

Bellevue, Washington, 98004, United States

Location

St. Joseph Hospital

Bellingham, Washington, 98225, United States

Location

Heart Clinics Northwest/ Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Wesley Hospital

Auchenflower, Queensland, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, 4061, Australia

Location

Monash Heart

Clayton, Victoria, 3168, Australia

Location

St. Vincent's Hospital

Melbourne, Victoria, 3065, Australia

Location

Epworth Hospital

Richmond, Victoria, 3121, Australia

Location

Royal Perth Hospital

Perth, Western Australia, Australia

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Robert Smith Jr, Ph.D., Sr Clinical Research Scientist
• Organization: Abbott Vascular

robert.smithjr@av.abbott.com

408-845-8265

Study Officials

• Marco Costa, MD, PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 9, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: February 1, 2014
• Last Updated: June 8, 2015
• Results First Posted: June 1, 2012

Record last verified: 2015-05

Locations

AU (6); US (56)