Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Ischemic Heart Disease, Stenotic Coronary Lesion
Conditions
Keywords
In-stent Late Lumen Loss (LLL), TARGET VESSEL FAILURE (TVF), MYOCARDIAL INFARCTION (MI), TARGET VESSEL REVASCULARIZATION (TVR), TARGET LESION REVASCULARIZATION (TLR), TARGET LESION FAILURE (TLF), STENT THROMBOSIS, RESTENOTIC LESION, PERCUTANEOUS CORONARY INTERVENTION (PCI), REAL-WORLD, THE RANDOMIZED CONTROLLED TRIAL
Brief summary
The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring stent implantation.
Detailed description
This study is a prospective, multicenter, randomized, two-arm, open-label study, designed to assess the non-inferiority of Resolute stent compared to Taxus Liberte stent in in-stent late lumen loss. The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring stent implantation. This trial will be conducted at approximately 20 sites and will enroll up to 400 subjects, randomized to the Resolute stent and Taxus Liberte stent in a 1:1 ratio. Subjects will be randomized using an interactive voice response system (IVRS). Due to the design characteristics of the devices, the study investigators and operators can not be blinded. However, the clinical event adjudication committee, consisting of cardiologists who are not participating in the study, will be blinded for the treatment arm of the subjects to avoid a potential bias in the adjudication process of events.
Interventions
DEVICETaxus Liberte Paclitaxel-Eluting Coronary Stent System
Taxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation
DEVICEResolute Zotarolimus-Eluting Coronary Stent System
Resolute Zotarolimus-Eluting Coronary Stent System Implantation
Sponsors
Medtronic Vascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient must meet all of the following criteria to be eligible for treatment in the trial: 1. Age ≥ 18 years or minimum age as required by local regulations 2. The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute stent and Taxus Liberte stent and the Declaration of Helsinki 3. The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form 4. Intention to electively implant at least one Resolute stent or Taxus Liberte stent 5. The patient is willing and able to cooperate with study procedures and required follow up visits
Exclusion criteria
Patients will be excluded from the trial if any of the following criteria are met: 1. Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, bivalirudin, cobalt, nickel, chromium, molybdenum, 316L stainless steel, polymer coatings (e.g. Biolinx), zotarolimus, paclitaxel, rapamycin, tacrolimus, everolimus, or any other analogue or derivative, or contrast media 2. Women with known pregnancy or who are lactating 3. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) 4. Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements 5. Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period 6. Previous enrollment in the Resolute China RCT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| in-stent late lumen loss (LLL) | 9 months | in-stent late lumen loss (LLL), defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent thrombosis | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr | As determined by Medtronic historic and ARC definitions. |
| Device success | at the end of the index procedure or during hospital stay | Definition 1: The attainment of \<50% residual stenosis of the target lesion using only the assigned device. Definition 2: The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis. |
| Death | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. |
| Myocardial infarction | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr | All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions. |
| MACE composite endpoint | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr | Death, myocardial infarction (MI) (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods. |
| Target vessel failure (TVF) | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr | A composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization(TVR. |
| All revascularizations | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr | Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR. |
| Target lesion failure (TLF) | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr | A composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods. |
| Lesion success | At the end of the index procedure or during hospital stay | Definition 1: The attainment of \<50% residual stenosis of the target lesion using any percutaneous method. Definition 2: The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis. |
| Procedure success | At the end of the index procedure or during hospital stay | Definition 1: The attainment of \<50% residual stenosis of the target lesion and no in-hospital MACE. Definition 2: The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis. |
| Composite endpoint of (all cause) mortality, Myocardial Infarction (Q-wave and non Q-wave) or (any) revascularization | 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr | Mortality, Myocardial Infarction (Q-wave and non Q wave) or (any) revascularization. |
Countries
China
Outcome results
None listed