BIOFLOW-III Israel Satellite Registry
|ClinicalTrials.gov Identifier: NCT01895712|
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : September 28, 2017
|Condition or disease|
|Coronary Artery Disease Myocardial Ischemia Diabetes Mellitus Type 1 or 2|
For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30%-50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures. The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.
An interesting group of analysis resulted to be diabetic patients. It has been concluded that the incidence of both nonocclusive and occlusive restenosis is higher in diabetic subjects after stenting as judged from comparison with historical control subjects. Results implicate accelerated restenosis as both a consequence of diabetes and a cause for increased mortality after PCI in diabetic patient.
Therefore this observational registry has been designed for the clinical evaluation of the Orsiro LESS in diabetic subjects (Diabetic patients type 1 or 2) requiring coronary revascularization with Drug Eluting Stents (DES). Results will contribute to the collection of clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in daily clinical practice.
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|Official Title:||Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III Canada|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
- Target Vessel Failure (TVF) [ Time Frame: 12 months ]Composite of cardiac death, any target vessel myocardial Infarction, coronary artery bypass graft and clinically driven target vessel revascularization)
- Target Lesion Failure (TLF) [ Time Frame: 12 months ]Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)
- Total death [ Time Frame: 12 months ]Total death
- Cardiac death [ Time Frame: 12-month ]Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death I death of unknown cause and all procedurerelated deaths, including those related to concomitant treatment.
- Stent Thrombosis [ Time Frame: 12-month ]Definite/probable-ARC define
- Target vessel myocardial infarction [ Time Frame: 12-month ]
Myocardial infarction will be adjudicated according to the Joint ESC/ACCF/AHA/WHF Task Force universal definition of myocardial infarction12
• 14and on the basis of the 2010 ARC extended historical definition of myocardial infarction.
- Target lesion revascularization (TLR) [ Time Frame: 12 months ]Defined as any repeat revascularization of the target lesion
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895712
|Rambam medical Center|
|Haifa, Israel, 31096|
|Carmel medical Center|
|Haifa, Israel, 34362|
|Hadassah medical Center|
|Jerusalem, Israel, 91120|
|Meir medical Center|
|Kfar Saba, Israel, 44410|
|Rabin Medical Center|
|Petah Tikva, Israel, 49104|
|Sheba medical Center|
|Tel Hashomer, Israel, 52621|
|Principal Investigator:||Ran Kornowski, Prof||Rabin Medical Center|