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Completed

NCT Number: NCT00596661

The TRIMAXX Coronary Stent Trial

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TriMaxx Coronary Stent placement

Device

Angioplasty with coronary artery stent placement

Other names: TriMaxx™ Coronary Stent

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)

    Time frame: 30 Days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 17, 2008
Registry last updated
Oct 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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