Coronary Artery Disease
Conditions
Keywords
coronary stent
Brief summary
The primary objective of the trial is to demonstrate the safety and feasibility of treating coronary artery lesions which have not been previously treated with the TRIMAXX Coronary stent system as compared to the reported results for commercially available non-drug eluting coronary stent systems which are indicated for the same treatments.
Detailed description
The TriMaxx study is a prospective, multicenter, non-randomized, single-arm trial intended to demonstrate the safety and feasibility of the TriMaxx Cornary Stent System. The study will enroll 100 subjects with de novo native coronary artery lesions who meet the eligibility criteria and agree to participate in the study. Subjects will be enrolled in a sequential manner. The safety and feasibility of the TRIMAXX stent will be evaluated by comparing the MACE rate that is observed 30 days post-procedure to the MACE rate for commercially available non-drug eluting stents. Secoandry evaluations will include analysis of clinical and angiographic parameters at 6 months. All subjects will undergo assessments at 30 days and at 6 months. Additionally, all subjects will undergo a follow-up angiogram at 6 months.
Interventions
DEVICETriMaxx Coronary Stent placement
Angioplasty with coronary artery stent placement
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible for catheter based treatment * Single coronary lesion requiring treatment * Lesion is accessible with stent device * Completes informed consent for participation * Stable condition (no symptoms of heart attack within 72 hours prior to treatment)
Exclusion criteria
* Normal lab values * Previous treatment in the affected artery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac Events(MACE). MACE defined as Cardiac Death, MI(Q-wave and Non Q-wave) and Rarget Vessel Revascularization (TVR) | 30 Days |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Outcome: MACE | 6 months |
| Clinical Outcome: Ischemia driven TVR | 6 months |
| Clinical Outcome: Ischemia driven Target LesionRevascularization(TLR) | 6 months |
| Clinical Outcome: Target Vessel Failure(TVF) | 6 months |
| Angiographic Outcome: Device Success defined as achievment of a final residual in-stent stenosis > 30%(by QCA) using the assigned device only | procedural |
| Angiographic Outcome: Procedural Success without the occurrence of cardiac death, Q-wave or Non Q-wave MI or repeat revascularization of the target lesion during the hospital stay. | hospital stay |
| Angiographic Outcome: Angiographic in-stent and in-segment binary restenosis rate(>/= 50% diameter stenosis) | at 6 months |
| Angiographic Outcome: In-stent, in-segment, proximal, and distal minimum lumen diameter(MLD)) | at 6 months |
| Angiographic Outcome: Angiographic in-stent late loss, defined as the difference between the post-procedural MLD and the follow-up MLD | at 6 months |
| Angiographic Outcome: Lesion Success defined as attainment of a >30% residual in-stent stenosis (by QCA) using any percutaneous method | procedural |
Countries
Brazil, Germany
Outcome results
None listed