Status:
TERMINATED
SPIRIT Small Vessel Registry
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Artery Disease
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 dise...
Eligibility Criteria
Inclusion
- General Inclusion Criteria
- 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.
- Angiographic Inclusion Criteria
- 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.
- General Exclusion Criteria
- 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).
- Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
- Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.
- Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
- 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).
- Subject is currently participating in another clinical study that has not yet completed its primary endpoint.
- 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
- 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.
- 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.
- Total occlusion (TIMI flow 0), prior to crossing with the wire.
- Another lesion requiring revascularization is located in the same epicardial vessel of either the target or non-target lesion.
- Restenotic lesion.
- Aorto-ostial lesion (within 3 mm of the aorta junction).
- Left main location.
- Lesion located within 2 mm of the origin of the LAD (left anterior descending) or LCX (left coronary artery)
- Extreme angulation (≥90°) or excessive tortuosity (≥ two 45° angles) proximal to or within the target or non-target lesion.
- Heavy calcification proximal to or within the target or non-target lesion(s).
- Target or non-target vessel contains thrombus as indicated in the angiographic images.
- 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).
- 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.
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00783796
Start Date
October 1 2008
End Date
December 1 2013
Last Update
May 8 2019
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85260
2
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
3
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
4
Morton Plant Hospital
Clearwater, Florida, United States, 33756