The TRIMAXX Coronary Stent Trial

Phase 1

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: TriMaxx Coronary Stent placement

• Registration Number: NCT00596661
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-17
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-10
• Last Update Posted: 2008-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRIMAXX	TriMaxx Coronary Stent placement	TRIMAXX Coronary Stent

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Angiographic Outcome: Lesion Success defined as attainment of a >30% residual in-stent stenosis (by QCA) using any percutaneous method	procedural
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.	hospital stay
Angiographic Outcome: Angiographic in-stent and in-segment binary restenosis rate(>/= 50% diameter stenosis)	at 6 months
Angiographic Outcome: In-stent, in-segment, proximal, and distal minimum lumen diameter(MLD))	at 6 months
Angiographic Outcome: Angiographic in-stent late loss, defined as the difference between the post-procedural MLD and the follow-up MLD	at 6 months

Trial Locations

Locations (3)

Instituto Do Coracao do Triangolo Mineiro; 🇧🇷 Uberlandia, Brazil

Johannes Gutenberg Universitat; 🇩🇪 Mainz, Germany

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 Sao Paulo,, Brazil