Status:
COMPLETED
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)
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Disease
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
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 bl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT01171820
Start Date
November 1 2006
End Date
July 1 2010
Last Update
June 27 2016
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Salzburger Landeskliniken
Salzburg, Austria
2
C.H.U. - Hopital Michallon
Grenoble, France
3
CHU Lille - Hôpital Cardiologique
Lille, France
4
Herzzentrum
Bernau, Germany