The TRIMAXX Coronary Stent Trial
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.
1 other identifier
interventional
100
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 coronary-artery-disease
Started May 2004
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 9, 2008
CompletedFirst Posted
Study publicly available on registry
January 17, 2008
CompletedOctober 15, 2008
October 1, 2008
1.3 years
January 9, 2008
October 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Clinical Outcome: MACE
6 months
Clinical Outcome: Ischemia driven TVR
6 months
Clinical Outcome: Ischemia driven Target LesionRevascularization(TLR)
6 months
Clinical Outcome: Target Vessel Failure(TVF)
6 months
Angiographic Outcome: Device Success defined as achievment of a final residual in-stent stenosis > 30%(by QCA) using the assigned device only
procedural
- +5 more secondary outcomes
Study Arms (1)
TRIMAXX
EXPERIMENTALTRIMAXX Coronary Stent
Interventions
Angioplasty with coronary artery stent placement
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Normal lab values
- Previous treatment in the affected artery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Instituto Do Coracao do Triangolo Mineiro
Uberlândia, Brazil
Johannes Gutenberg Universitat
Mainz, Germany
Related Publications (1)
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.
PMID: 18044791RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 9, 2008
First Posted
January 17, 2008
Study Start
May 1, 2004
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
October 15, 2008
Record last verified: 2008-10