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The TRIMAXX Coronary Stent Trial

This study has been completed.
Sponsor:
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00596661
First received: January 9, 2008
Last updated: October 10, 2008
Last verified: October 2008
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
 Device: TriMaxx Coronary Stent placement
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical Outcome: MACE [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Clinical Outcome: Ischemia driven TVR [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Clinical Outcome: Ischemia driven Target LesionRevascularization(TLR) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Clinical Outcome: Target Vessel Failure(TVF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Angiographic Outcome: Lesion Success defined as attainment of a >30% residual in-stent stenosis (by QCA) using any percutaneous method [ Time Frame: procedural ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Angiographic Outcome: Angiographic in-stent and in-segment binary restenosis rate(>/= 50% diameter stenosis) [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
  • Angiographic Outcome: In-stent, in-segment, proximal, and distal minimum lumen diameter(MLD)) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: May 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRIMAXX
TRIMAXX Coronary Stent
 Device: TriMaxx Coronary Stent placement
Angioplasty with coronary artery stent placement
Other Name: TriMaxx™ Coronary Stent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596661

Locations
Brazil
Instituto Dante Pazzanese de Cardiologia
Sao Paulo,, Brazil
Instituto Do Coracao do Triangolo Mineiro
Uberlandia, Brazil
Germany
Johannes Gutenberg Universitat
Mainz, Germany
Sponsors and Collaborators
Abbott Vascular
Investigators
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
  More Information

Publications:

Responsible Party: Matt Kiely, Manager Medical Information, Abbott Vascular
ClinicalTrials.gov Identifier: NCT00596661     History of Changes
Other Study ID Numbers: AVD 640-0051-01
Study First Received: January 9, 2008
Last Updated: October 10, 2008
Health Authority: Brazil: National Committee of Ethics in Research
Germany: Ethics Commission

Keywords provided by Abbott Vascular:
coronary stent

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

ClinicalTrials.gov processed this record on May 19, 2013