SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)

SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions

The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions in patients (Diabetic sub-study).

The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic sub-study and the Registry.

The SPIRIT V Diabetic sub-study is a prospective, randomized, active-controlled, single blind, parallel two-arm multi-center study comparing the XIENCE V® EECSS to the TAXUS® Liberté™ in the treatment of diabetic patients with coronary artery lesions who will fulfill the eligibility criteria. Approximately 300 patients will be randomized (2:1) against the TAXUS® Liberté™ coronary stent system. These patients will be recruited in up to 40 selected sites.

The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.

The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.

Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Diabetic study after 1 year.

Inclusion Criteria:

• at least 18 years
• able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
• diagnosed with diabetes, as documented by medical history.
• evidence of myocardial ischemia
• acceptable candidate for coronary artery bypass grafting (CABG) surgery
• agree to undergo all clinical investigation plan (CIP)-required follow-up examinations
• artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents
• maximum of one, de novo, target lesion per native major epicardial vessel or side branch
• target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
• target lesion ≤ 28 mm in length by visual estimate
• target lesion must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% and a TIMI flow > 1

Exclusion Criteria:

• known diagnosis of acute myocardial infarction within 72 hours preceding the index procedure
• current unstable arrhythmias
• Left ventricular ejection fraction < 30%
• received a heart or any other organ transplant or is on a waiting list for any organ transplant
• receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
• receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease
• known hypersensitivity or contraindication to specific agents
• elective surgery is planned within the first 9 months after the procedure that will require discontinuing either aspirin or clopidogrel
• platelet count limits, white blood cell limits or documented or suspected liver disease
• renal insufficiency
• history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Cerebrovascular accident or transient ischemic attack within the past 6 months
• significant GI or urinary bleed within the past 6 months
• history of other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse that may cause non-compliance with the CIP, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)

Target lesion meets any of the following criteria:

• In-stent restenotic
• aorto-ostial location (within 3 mm)
• left main location
• located within 2 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX)
• located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation)
• lesion involving a side branch ≥ 2.5 mm in diameter
• lesion involving a side branch with > 50% stenosis by visual estimation Lesion involving a side branch requiring predilatation
• located in a major epicardial vessel that has been previously treated with brachytherapy
• located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy), < 9 months prior to the index procedure
• total occlusion (TIMI flow 0), prior to wire crossing
• excessive tortuosity proximal to or within the lesion
• extreme angulation (≥ 90%) proximal to or within the lesion
• heavy calcification

The target vessel contains visible thrombus

Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. brachytherapy)

Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required