The TRIMAXX Coronary Stent Trial

NCT ID: NCT00596661

Last Updated: 2008-10-15

Basic Information

• 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

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

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

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TRIMAXX

TRIMAXX Coronary Stent

Group Type: EXPERIMENTAL

TriMaxx Coronary Stent placement

Intervention Type: DEVICE

Angioplasty with coronary artery stent placement

Interventions

TriMaxx Coronary Stent placement

Angioplasty with coronary artery stent placement

Intervention Type: DEVICE

Other Intervention Names

TriMaxx™ Coronary Stent

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott Vascular

Principal Investigators

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

Instituto Dante Pazzanese de Cardiologia

São Paulo, , Brazil

Instituto Do Coracao do Triangolo Mineiro

Uberlândia, , Brazil

Johannes Gutenberg Universitat

Mainz, , Germany

Countries

Brazil; Germany

References

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

AVD 640-0051-01

Identifier Type: -

Identifier Source: org_study_id