The TRIMAXX Coronary Stent Trial

Abbott Medical Devices100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Coronary Artery Disease

Interventions

TriMaxx Coronary Stent placementDEVICE

Angioplasty with coronary artery stent placement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Instituto Do Coracao do Triangolo Mineiro

Uberlândia, Brazil

Johannes Gutenberg Universitat

Mainz, Germany

Outcomes

Primary Outcomes

Major Adverse Cardiac Events(MACE). MACE defined as Cardiac Death, MI(Q-wave and Non Q-wave) and Rarget Vessel Revascularization (TVR)

Time frame: 30 Days

Secondary Outcomes

Clinical Outcome: MACE

Time frame: 6 months

Clinical Outcome: Ischemia driven TVR

Time frame: 6 months

Clinical Outcome: Ischemia driven Target LesionRevascularization(TLR)

Time frame: 6 months

Clinical Outcome: Target Vessel Failure(TVF)

Time frame: 6 months

Angiographic Outcome: Device Success defined as achievment of a final residual in-stent stenosis > 30%(by QCA) using the assigned device only

Time frame: procedural

Angiographic Outcome: Lesion Success defined as attainment of a >30% residual in-stent stenosis (by QCA) using any percutaneous method

Time frame: 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.

Time frame: hospital stay

Angiographic Outcome: Angiographic in-stent and in-segment binary restenosis rate(>/= 50% diameter stenosis)

Time frame: at 6 months

Angiographic Outcome: In-stent, in-segment, proximal, and distal minimum lumen diameter(MLD))

Data from ClinicalTrials.gov

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