SPIRIT Small Vessel Registry

NCT00783796 | Terminated Results DMC

• 1 other identifier: 08-383
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 34

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.

Conditions

Coronary Artery Disease; Atherosclerosis; Myocardial Ischemia

Keywords

Coronary artery disease; Atherosclerosis; Myocardial ischemia

Outcome Measures

Primary Outcomes (3)

• Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).

  This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.

  1 year

• Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).

  This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.

  2 years

• Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).

  This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.

  3 years

Secondary Outcomes (96)

• Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)

  From start of index procedure to end of index procedure

• Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)

  From the start of index procedure to end of index procedure

• In-Stent Late Loss

  240 days

• In-segment Late Loss (LL)

  240 Days

• Proximal Late Loss

  240 days

Study Arms (1)

2.25mm XIENCE V®

EXPERIMENTAL

Patients receiving the 2.25 mm XIENCE V® stent

Device: 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System

Interventions

2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System DEVICE

Treatment of a maximum of two de novo native coronary artery lesions in small vessels.

2.25mm XIENCE V®

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.
• 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 not to participate in any other clinical study for a period of one year following the index procedure.
• One target or two (two target or one target and one non-target) de novo lesion(s), each in a different epicardial vessel.
• If there are two target lesions or one target and one non-target lesion, both lesions must satisfy the angiographic eligibility criteria.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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 radiation therapy to the chest or 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).
• Subjects who 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 fluoropolymers 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 WBC (white blood cell) of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
• Subject has known renal insufficiency (eg, serum creatinine level ≥ 2.5 mg/dL, or on dialysis).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (34)

Scottsdale Healthcare

Scottsdale, Arizona, 85260, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Washington Hospital Center

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

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Sacred Heart Hospital

Pensacola, Florida, 32504-8721, United States

Location

St. Anthony Hospital

Rockford, Illinois, 61107, United States

Location

St. John's Hospital / Prairie Education & Research Cooperative

Springfield, Illinois, 62769, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

St. Joseph Medical Center

Towson, Maryland, 21204, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

St. Joseph Mercy Hospital

Ypsilanti, Michigan, 48197, United States

Location

St. Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

St. Patrick Hospital

Missoula, Montana, 59802, United States

Location

Cooper Health System

Camden, New Jersey, 08103, United States

Location

Gotham Cardiovascular Reasearch, PC. (St. Vincent's Medical Center-closing, pts moved)

New York, New York, 10011, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

WakeMed Hospital

Raleigh, North Carolina, 27610, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Case Medical Center

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

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Sanford USD Medical Center

Sioux Falls, South Dakota, 57104, United States

Location

Baptist West Hospital

Knoxville, Tennessee, 37934, United States

Location

Northwest Texas Healthcare System

Amarillo, Texas, 79106, United States

Location

Mother Frances Hospital

Tyler, Texas, 75701, United States

Location

Overlake Hospital Medical Center

Bellevue, Washington, 98004, United States

Location

St. Joseph Hospital

Bellingham, Washington, 98225, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Myocardial Ischemia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: David R Rutledge
• Organization: Abbott Vascular

david.rutledge@av.abbott.com

(408) 845-3820

Study Officials

• Marco A. Costa, MD, PhD

  Case Western University Hospital, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: November 3, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2013
• Last Updated: May 8, 2019
• Results First Posted: January 5, 2012

Record last verified: 2019-04

Locations

US (34)