Clinical trial NCT00916370: SPIRIT PRIME Clinical Trial
Official title: SPIRIT PRIME Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-06-09
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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.

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 1 year
measure: Target Lesion Failure (TLF)
timeFrame: 2 years
measure: Target Lesion Failure (TLF)
timeFrame: 3 years
Secondary outcomes:
measure: Procedure Time
timeFrame: From insertion to withdrawal of guide catheter
measure: Device Success (Lesion Basis)
timeFrame: From the start of index procedure to end of index procedure
measure: Procedural Success (Subject Basis)
timeFrame: From the start of index procedure to end of index procedure
measure: All Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: In-hospital is less than or equal to 7 days post index procedure
measure: All Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 30 days
measure: All Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 180 days
measure: All Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 1 year
measure: All Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 2 years
measure: All Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 3 years
measure: Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
timeFrame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.
measure: Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
timeFrame: 30 days
measure: Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
timeFrame: 180 days
measure: Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
timeFrame: 1 year
measure: Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
timeFrame: 2 years
measure: Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
timeFrame: 3 years
measure: Non-target Vessel MI (Q-wave, Non Q-wave)
timeFrame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
measure: Non-target Vessel MI (Q-wave, Non Q-wave)
timeFrame: 30 days
measure: Non-target Vessel MI (Q-wave, Non Q-wave)
timeFrame: 180 days
measure: Non-target Vessel MI (Q-wave, Non Q-wave)
timeFrame: 1 year
measure: Non-target Vessel MI (Q-wave, Non Q-wave)
timeFrame: 2 years
measure: Non-target Vessel MI (Q-wave, Non Q-wave)
timeFrame: 3 years
measure: Clinically Indicated-Target Lesion Revascularization
timeFrame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
measure: Clinically Indicated-Target Lesion Revascularization
timeFrame: 30 days
measure: Clinically Indicated-Target Lesion Revascularization
timeFrame: 180 days
measure: Clinically Indicated-Target Lesion Revascularization
timeFrame: 1 year
measure: Clinically Indicated-Target Lesion Revascularization
timeFrame: 2 years
measure: Clinically Indicated-Target Lesion Revascularization
timeFrame: 3 years
measure: Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
timeFrame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
measure: Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
timeFrame: 30 days
measure: Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
timeFrame: 180 days
measure: Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
timeFrame: 1 year
measure: Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
timeFrame: 2 years
measure: Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
timeFrame: 3 years
measure: All TLR (CI and Non-CI)
timeFrame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
measure: All TLR (CI and Non-CI)
timeFrame: 30 days
measure: All TLR (CI and Non-CI)
timeFrame: 180 days
measure: All TLR (CI and Non-CI)
timeFrame: 1 year
measure: All TLR (CI and Non-CI)
timeFrame: 2 years
measure: All TLR (CI and Non-CI)
timeFrame: 3 years
measure: All TVR (CI and Non-CI)
timeFrame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
measure: All TVR (CI and Non-CI)
timeFrame: 30 days
measure: All TVR (CI and Non-CI)
timeFrame: 180 days
measure: All TVR (CI and Non-CI)
timeFrame: 1 year
measure: All TVR (CI and Non-CI)
timeFrame: 2 years
measure: All TVR (CI and Non-CI)
timeFrame: 3 years
measure: All Coronary Revascularization (TVR and Non-TVR)
timeFrame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
measure: All Coronary Revascularization (TVR and Non-TVR)
timeFrame: 30 days
measure: All Coronary Revascularization (TVR and Non-TVR)
timeFrame: 180 days
measure: All Coronary Revascularization (TVR and Non-TVR)
timeFrame: 1 year
measure: All Coronary Revascularization (TVR and Non-TVR)
timeFrame: 2 years
measure: All Coronary Revascularization (TVR and Non-TVR)
timeFrame: 3 years
measure: Cardiac Death/All MI
timeFrame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
measure: Cardiac Death/ All MI
timeFrame: 30 days
measure: Cardiac Death/All MI
timeFrame: 180 days
measure: Cardiac Death/All MI
timeFrame: 1 year
measure: Cardiac Death/All MI
timeFrame: 2 years
measure: Cardiac Death/All MI
timeFrame: 3 years
measure: Cardiac Death/ All MI/CI-TLR
timeFrame: in-hospital
measure: Cardiac Death/ All MI/CI-TLR
timeFrame: 30 days
measure: Cardiac Death/ All MI/CI-TLR
timeFrame: 180 days
measure: Cardiac Death/ All MI/CI-TLR
timeFrame: 1 year
measure: Cardiac Death/ All MI/CI-TLR
timeFrame: 2 years
measure: Cardiac Death/ All MI/CI-TLR
timeFrame: 3 years
measure: All Death/All MI/All Coronary Revascularization
timeFrame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
measure: All Death/All MI/All Coronary Revascularization
timeFrame: 30 days
measure: All Death/All MI/All Coronary Revascularization
timeFrame: 180 days
measure: All Death/All MI/All Coronary Revascularization
timeFrame: 1 year
measure: All Death/All MI/All Coronary Revascularization
timeFrame: 2 years
measure: All Death/All MI/All Coronary Revascularization
timeFrame: 3 years
measure: Stent Thrombosis
timeFrame: Acute (≤1 day)
measure: Stent Thrombosis
timeFrame: Subacute (>1 - 30 days)
measure: Stent Thrombosis
timeFrame: Acute/Subacute (0 - 30 days)
measure: Stent Thrombosis
timeFrame: Late (31 - 393 days)
measure: Stent Thrombosis
timeFrame: Late (31 - 758 days)
measure: Stent Thrombosis
timeFrame: Very Late (394 - 758 days)
measure: Stent Thrombosis
timeFrame: Late (31 - 1123 days)
measure: Stent Thrombosis
timeFrame: Very Late (394 - 1123 days)
measure: Stent Thrombosis
timeFrame: Overall (0-393 days)
measure: Stent Thrombosis
timeFrame: Overall (0-758 days)
measure: Stent Thrombosis
timeFrame: Overall (0-758 days)
measure: Stent Thrombosis
timeFrame: Overall (0 - 1123 days)
measure: Stent Thrombosis
timeFrame: Overall (0 - 1123 days)
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Thomas Hospital
state: Alabama
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Jacksonville
country: United States
facility: St. Vincents Medical Center
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital of Pensicola
state: Florida
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center P.C.
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Shreveport
country: United States
facility: Willis Knighton Health System, Pierremont
state: Louisiana
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Regional Medical Center
state: Maryland
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Hyannis
country: United States
facility: Cape Cod Hospital
state: Massachusetts
city: Bay City
country: United States
facility: Bay Regional Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: St. Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Missoula
country: United States
facility: St. Patrick Hospital
state: Montana
city: Camden
country: United States
facility: Cooper Health System
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Gotham Cardiology
state: New York
city: NY
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital - Charlotte
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Elyria
country: United States
facility: EMH Regional Medical Center
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Mercy Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Hillcrest Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health @ Harrisburg Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Northwest Texas Healthcare System
state: Texas
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Pearland
country: United States
facility: The Methodist Hospital
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
city: Bellingham
country: United States
facility: St. Joseph Hospital
state: Washington
city: Spokane
country: United States
facility: Heart Clinics Northwest/ Sacred Heart Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Auchenflower
country: Australia
facility: Wesley Hospital
state: Queensland
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Clayton
country: Australia
facility: Monash Heart
state: Victoria
city: Melbourne
country: Australia
facility: St. Vincent's Hospital
state: Victoria
city: Richmond
country: Australia
facility: Epworth Hospital
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Marco Costa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: