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The TRIMAXX Coronary Stent Trial

2014-08-27 03:33:40 | BioPortfolio

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.

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.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Coronary Artery Disease

Intervention

TriMaxx Coronary Stent placement

Location

Instituto Dante Pazzanese de Cardiologia
Sao Paulo,
Brazil

Status

Completed

Source

Abbott Vascular

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:33:40-0400

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