The TRIMAXX Coronary Stent Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00596661
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : October 15, 2008
Information provided by:
Abbott Vascular

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: TriMaxx Coronary Stent placement Phase 1

Detailed 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Non-Randomized, Single-Arm Trial to Evaluate the Safety and Feasibility of the TriMaxx Coronary Stent in de Novo Coronary Artery Lesions.
Study Start Date : May 2004
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Arm Intervention/treatment
Experimental: TRIMAXX
TRIMAXX Coronary Stent
Device: TriMaxx Coronary Stent placement
Angioplasty with coronary artery stent placement
Other Name: TriMaxx™ Coronary Stent

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Clinical Outcome: MACE [ Time Frame: 6 months ]
  2. Clinical Outcome: Ischemia driven TVR [ Time Frame: 6 months ]
  3. Clinical Outcome: Ischemia driven Target LesionRevascularization(TLR) [ Time Frame: 6 months ]
  4. Clinical Outcome: Target Vessel Failure(TVF) [ Time Frame: 6 months ]
  5. 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 ]
  6. Angiographic Outcome: Lesion Success defined as attainment of a >30% residual in-stent stenosis (by QCA) using any percutaneous method [ Time Frame: procedural ]
  7. 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 ]
  8. Angiographic Outcome: Angiographic in-stent and in-segment binary restenosis rate(>/= 50% diameter stenosis) [ Time Frame: at 6 months ]
  9. Angiographic Outcome: In-stent, in-segment, proximal, and distal minimum lumen diameter(MLD)) [ Time Frame: at 6 months ]
  10. Angiographic Outcome: Angiographic in-stent late loss, defined as the difference between the post-procedural MLD and the follow-up MLD [ Time Frame: at 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00596661

Instituto Dante Pazzanese de Cardiologia
Sao Paulo,, Brazil
Instituto Do Coracao do Triangolo Mineiro
Uberlandia, Brazil
Johannes Gutenberg Universitat
Mainz, Germany
Sponsors and Collaborators
Abbott Vascular
Principal Investigator: Alexandre Abizaid, MD Instituto Dante Pazzanese de Cardioloigia, Sao Paulo, Brazil
Principal Investigator: Jeffery J Popma, MD Brigham and Women's Hospital. Boston, Massachusetts, USA

Publications of Results:
Responsible Party: Matt Kiely, Manager Medical Information, Abbott Vascular Identifier: NCT00596661     History of Changes
Other Study ID Numbers: AVD 640-0051-01
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: October 15, 2008
Last Verified: October 2008

Keywords provided by Abbott Vascular:
coronary stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases