Clinical trial NCT00783796: SPIRIT Small Vessel Registry
Official title: Spirit Small Vessel Registry (SPIRIT SV)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Atherosclerosis
Myocardial Ischemia
Keywords: Coronary artery disease
Atherosclerosis
Myocardial ischemia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and effectiveness of the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions in small vessels, each in a different epicardial vessel.


Eligibility criteria: General 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.
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 not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

1. One target or two (two target or one target and one non-target) de novo lesion(s), each in a different epicardial vessel.
2. If there are two target lesions or one target and one non-target lesion, both lesions must satisfy the angiographic eligibility criteria.
3. The target lesion(s) or non-target lesion 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. The target lesion(s) or non-target lesion must be located in a native coronary artery with a reference vessel diameter by visual estimation of: Target Lesion: ≥ 2.25 mm to \< 2.5 mm for treatment by the 2.25 mm XIENCE V® EECS.

   Non-target Lesion: ≥2.5 mm to ≤4.25 mm for treatment by the commercial XIENCE V® EECS.
5. The target lesion(s) or non-target lesion must be located in a native coronary artery with a lesion length by visual estimation of ≤28 mm.

General Exclusion Criteria

1. Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB (creatine kinase myocardial-band isoenzyme) ≥2 times the upper limit of normal) and CK and CK-MB levels 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.
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 radiation therapy to the chest or 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. Subjects who 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 fluoropolymers 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 WBC (white blood cell) of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
15. Subject has known renal insufficiency (eg, 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

1. Target lesion(s) or non-target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and \> 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
2. Target lesion(s) or non-target lesion involving a bifurcation with a side branch ≥2 mm in diameter and/or ostial lesion \> 40% stenosed by visual estimation or side branch requiring protection guide wire, or side branch requiring dilatation.
3. Total occlusion (TIMI flow 0), prior to crossing with the wire.
4. Another lesion requiring revascularization is located in the same epicardial vessel of either the target or non-target lesion.
5. Restenotic lesion.
6. Aorto-ostial lesion (within 3 mm of the aorta junction).
7. Left main location.
8. Lesion located within 2 mm of the origin of the LAD (left anterior descending) or LCX (left coronary artery)
9. Extreme angulation (≥90°) or excessive tortuosity (≥ two 45° angles) proximal to or within the target or non-target lesion.
10. Heavy calcification proximal to or within the target or non-target lesion(s).
11. Target or non-target vessel contains thrombus as indicated in the angiographic images.
12. Target lesion(s) or non-target lesion have a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treating the target and non-target vessel(s) (e.g. atherectomy, cutting balloon).
13. Target or non-target vessel(s) have previously been treated with percutaneous intervention (e.g. balloon angioplasty, stent, cutting balloon, atherectomy) \< 9 months prior to index procedure.
14. A vessel not intended to be treated with a 2.25 mm XIENCE V® EECS or commercial sizes of XIENCE V® EECS that was previously treated with any type of PCI (percutaneous coronary intervention) \< 90 days prior to the index procedure.
15. Additional clinically significant lesion(s) (e.g., %DS (diameter stenosis) ≥ 50%) is present in any vessel or side branch for which PCI may be required \< 90 days after the index procedure.

Primary outcomes:
measure: Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).
timeFrame: 1 year
measure: Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).
timeFrame: 2 years
measure: Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).
timeFrame: 3 years
Secondary outcomes:
measure: Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)
timeFrame: From start of index procedure to end of index procedure
measure: Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)
timeFrame: From the start of index procedure to end of index procedure
measure: In-Stent Late Loss
timeFrame: 240 days
measure: In-segment Late Loss (LL)
timeFrame: 240 Days
measure: Proximal Late Loss
timeFrame: 240 days
measure: Distal Late Loss
timeFrame: 240 days
measure: In-stent % Diameter Stenosis
timeFrame: 240 days
measure: In-segment % Diameter Stenosis
timeFrame: 240 days
measure: Proximal % Diameter Stenosis
timeFrame: 240 days
measure: Distal % Diameter Stenosis
timeFrame: 240 days
measure: In-stent Angiographic Binary Restenosis (ABR) Rate
timeFrame: 240 days
measure: In-segment Angiographic Binary Restenosis (ABR) Rate
timeFrame: 240 days
measure: Proximal Angiographic Binary Restenosis (ABR) Rate
timeFrame: 240 days
measure: Distal Angiographic Binary Restenosis (ABR) Rate
timeFrame: 240 days
measure: All Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 30 days
measure: All Death (Cardiac, Vascular, Non-cardiovascular)
timeFrame: 240 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 MI - Q-wave and Non Q-wave (Per Protocol)
timeFrame: 30 days
measure: Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
timeFrame: 240 days
measure: Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
timeFrame: 1 year
measure: Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
timeFrame: 2 years
measure: Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
timeFrame: 3 years
measure: Stent Thrombosis (ARC Defined)
timeFrame: 0 to 1 day (Acute)
measure: Stent Thrombosis (ARC Defined)
timeFrame: greater than 1 day to 30 days (Subacute)
measure: Stent Thrombosis (ARC Defined)
timeFrame: 31 days - 393 days (Late)
measure: Stent Thrombosis (ARC Defined)
timeFrame: >1 year (Very late)
measure: Stent Thrombosis (ARC Defined)
timeFrame: 394 - 758 days (Very Late)
measure: Stent Thrombosis (ARC Defined)
timeFrame: 394 - 1123 days (Very Late)
measure: Stent Thrombosis (ARC Defined)
timeFrame: Overall (0 - 393 days)
measure: Stent Thrombosis (ARC Defined)
timeFrame: Overall (0 - 758 days)
measure: Stent Thrombosis (ARC Defined)
timeFrame: Overall (0 - 1123 days)
measure: Stent Thrombosis (Protocol Defined)
timeFrame: 0 to 1 day (Acute)
measure: Stent Thrombosis (Protocol Defined)
timeFrame: > 1 day to 30 days (Subacute)
measure: Stent Thrombosis (Protocol Defined)
timeFrame: 31 days to 393 days (Late)
measure: Stent Thrombosis (Protocol Defined)
timeFrame: 31 - 758 days (Late)
measure: Stent Thrombosis (Protocol Defined)
timeFrame: 31 - 1123 days (Late)
measure: Stent Thrombosis (Protocol Defined)
timeFrame: Overall (0 - 393 days)
measure: Stent Thrombosis (Protocol Defined)
timeFrame: Overall (0 - 758 days)
measure: Stent Thrombosis (Protocol Defined)
timeFrame: Overall (0 - 1123 days)
measure: All Death/ All MI/All Coronary Revascularization
timeFrame: 30 days
measure: All Death/ All MI/All Coronary Revascularization
timeFrame: 240 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: Cardiac Death/ All MI /CI-TLR
timeFrame: 30 days
measure: Cardiac Death/ All MI /CI-TLR
timeFrame: 240 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: Cardiac Death/MI
timeFrame: 30 days
measure: Cardiac Death/MI
timeFrame: 240 days
measure: Cardiac Death/MI
timeFrame: 1 year
measure: Cardiac Death/MI
timeFrame: 2 years
measure: Cardiac Death/MI
timeFrame: 3 years
measure: All Coronary Revascularization (TVR and Non-TVR)
timeFrame: 30 days
measure: All Coronary Revascularization (TVR and Non-TVR)
timeFrame: 240 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: All TVR (CI and Non-CI)
timeFrame: 30 days
measure: All TVR (CI and Non-CI)
timeFrame: 240 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 TLR (CI and Non-CI)
timeFrame: 30 days
measure: All TLR (CI and Non-CI)
timeFrame: 240 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: Clinically Indicated Target Vessel Revascularization (TVR)
timeFrame: 30 days
measure: Clinically Indicated Target Vessel Revascularization
timeFrame: 240 days
measure: Clinically Indicated Target Vessel Revascularization
timeFrame: 1 year
measure: Clinically Indicated Target Vessel Revascularization
timeFrame: 2 years
measure: Clinically Indicated Target Vessel Revascularization
timeFrame: 3 years
measure: Clinically Indicated Target Lesion Revascularization (CI-TLR)
timeFrame: 30 days
measure: Clinically Indicated Target Lesion Revascularization (CI-TLR)
timeFrame: 240 days
measure: Clinically Indicated Target Lesion Revascularization (CI-TLR)
timeFrame: 1 year
measure: Clinically Indicated Target Lesion Revascularization (CI-TLR)
timeFrame: 2 years
measure: Clinically Indicated Target Lesion Revascularization (CI-TLR)
timeFrame: 3 years
measure: Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
timeFrame: 30 days
measure: Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
timeFrame: 240 days
measure: Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
timeFrame: 1 year
measure: Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
timeFrame: 2 years
measure: Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
timeFrame: 3 years
measure: Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
timeFrame: 30 days
measure: Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
timeFrame: 240 days
measure: Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
timeFrame: 1 year
measure: Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
timeFrame: 2 years
measure: Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
timeFrame: 3 years
measure: Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
timeFrame: 30 days
measure: Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
timeFrame: 240 days
measure: Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
timeFrame: 1 year
measure: Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
timeFrame: 2 years
measure: Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
timeFrame: 3 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
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: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Rockford
country: United States
facility: St. Anthony Hospital
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital / Prairie Education & Research Cooperative
state: Illinois
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Towson
country: United States
facility: St. Joseph Medical Center
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Saint Cloud
country: United States
facility: St. Cloud Hospital
state: Minnesota
city: Missoula
country: United States
facility: St. Patrick Hospital
state: Montana
city: Camden
country: United States
facility: Cooper Health System
state: New Jersey
city: New York
country: United States
facility: Gotham Cardiovascular Reasearch, PC. (St. Vincent's Medical Center-closing, pts moved)
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
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: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Knoxville
country: United States
facility: Baptist West Hospital
state: Tennessee
city: Amarillo
country: United States
facility: Northwest Texas Healthcare System
state: Texas
city: Tyler
country: United States
facility: Mother Frances Hospital
state: Texas
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
city: Bellingham
country: United States
facility: St. Joseph Hospital
state: Washington
Study officials:
affiliation: Case Western University Hospital, Cleveland, OH
name: Marco A. Costa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: