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TriMaxx Coronary Stent placement

Phase 1

Coronary Artery Disease | Unknown | Cardiovascular |Abbott Laboratories|Last Updated: Oct 15, 2008

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

TriMaxx Coronary Stent placement · 1 trial · 1 indication

Phase 1 1
NCT00596661The TRIMAXX Coronary Stent TrialCoronary Artery Disease
COMPLETED100 Analytics
PHASE1COMPLETED
The TRIMAXX Coronary Stent Trial
Coronary Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Clinical Outcome: MACE
6 months
Clinical Outcome: Ischemia driven TVR
6 months
Clinical Outcome: Ischemia driven Target LesionRevascularization(TLR)
6 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TRIMAXXEXPERIMENTALTRIMAXX Coronary Stent

Interventions

NameTypeDescription
TriMaxx Coronary Stent placementDEVICEAngioplasty with coronary artery stent placement
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

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: ...

Countries:BrazilGermany
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Frequently asked questions about TriMaxx Coronary Stent placement

What is TriMaxx Coronary Stent placement used for?

TriMaxx Coronary Stent placement is used for treating Coronary Artery Disease. It is an investigational device being studied in a clinical trial to assess its safety and performance in patients with this condition. The stent is placed in coronary arteries to help keep them open and restore blood flow.

Who makes TriMaxx Coronary Stent placement?

TriMaxx Coronary Stent placement is developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. Abbott is conducting clinical research to evaluate this investigational coronary stent for the treatment of Coronary Artery Disease.

What phase is TriMaxx Coronary Stent placement in?

TriMaxx Coronary Stent placement is in Phase 1 clinical development. It is an investigational device and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the device is still in the early stages of clinical evaluation for Coronary Artery Disease.

What clinical trials is TriMaxx Coronary Stent placement in?

TriMaxx Coronary Stent placement has one completed clinical trial, identified as NCT00596661, titled "The TRIMAXX Coronary Stent Trial." This Phase 1 study enrolled 100 participants with Coronary Artery Disease at sites in Brazil and Germany. The trial was uncontrolled and not randomized or double-blinded.

Is TriMaxx Coronary Stent placement FDA approved?

TriMaxx Coronary Stent placement is not FDA approved. It is an investigational device currently in Phase 1 clinical development. The completed Phase 1 trial, NCT00596661, evaluated the stent in 100 patients with Coronary Artery Disease, but the device has not yet received marketing authorization.