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The TRIMAXX Coronary Stent Trial

NCT ID: NCT00596661

Last Updated: 2008-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Keywords

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coronary stent

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TRIMAXX

TRIMAXX Coronary Stent

Group Type EXPERIMENTAL

TriMaxx Coronary Stent placement

Intervention Type DEVICE

Angioplasty with coronary artery stent placement

Interventions

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TriMaxx Coronary Stent placement

Angioplasty with coronary artery stent placement

Intervention Type DEVICE

Other Intervention Names

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TriMaxx™ Coronary Stent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott Vascular

Principal Investigators

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Alexandre Abizaid, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dante Pazzanese de Cardioloigia, Sao Paulo, Brazil

Jeffery J Popma, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital. Boston, Massachusetts, USA

Locations

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Instituto Dante Pazzanese de Cardiologia

São Paulo, , Brazil

Site Status

Instituto Do Coracao do Triangolo Mineiro

Uberlândia, , Brazil

Site Status

Johannes Gutenberg Universitat

Mainz, , Germany

Site Status

Countries

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Brazil Germany

References

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Abizaid A, Popma JJ, Tanajura LF, Hattori K, Solberg B, Larracas C, Feres F, Costa Jde R Jr, Schwartz LB. Clinical and angiographic results of percutaneous coronary revascularization using a trilayer stainless steel-tantalum-stainless steel phosphorylcholine-coated stent: the TriMaxx trial. Catheter Cardiovasc Interv. 2007 Dec 1;70(7):914-9. doi: 10.1002/ccd.21279.

Reference Type RESULT
PMID: 18044791 (View on PubMed)

Other Identifiers

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AVD 640-0051-01

Identifier Type: -

Identifier Source: org_study_id