The TRIMAXX Coronary Stent Trial
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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