The TRIMAXX Coronary Stent Trial

Coronary Artery Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596661
• Other study ID #: AVD 640-0051-01
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2008
• Last updated: October 10, 2008
• Start date: May 2004
• Est. completion date: September 2005

Study information

• Verified date: October 2008
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• TriMaxx Coronary Stent placement
Angioplasty with coronary artery stent placement

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paulo,
Brazil	Instituto Do Coracao do Triangolo Mineiro	Uberlandia
Germany	Johannes Gutenberg Universitat	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

Brazil,  Germany, 

References & 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 phosphorylchol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events(MACE). MACE defined as Cardiac Death, MI(Q-wave and Non Q-wave) and Rarget Vessel Revascularization (TVR)		30 Days	Yes
Secondary	Clinical Outcome: MACE		6 months	Yes
Secondary	Clinical Outcome: Ischemia driven TVR		6 months	Yes
Secondary	Clinical Outcome: Ischemia driven Target LesionRevascularization(TLR)		6 months	Yes
Secondary	Clinical Outcome: Target Vessel Failure(TVF)		6 months	Yes
Secondary	Angiographic Outcome: Device Success defined as achievment of a final residual in-stent stenosis > 30%(by QCA) using the assigned device only		procedural	No
Secondary	Angiographic Outcome: Lesion Success defined as attainment of a >30% residual in-stent stenosis (by QCA) using any percutaneous method		procedural	No
Secondary	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	Yes
Secondary	Angiographic Outcome: Angiographic in-stent and in-segment binary restenosis rate(>/= 50% diameter stenosis)		at 6 months	Yes
Secondary	Angiographic Outcome: In-stent, in-segment, proximal, and distal minimum lumen diameter(MLD))		at 6 months	No
Secondary	Angiographic Outcome: Angiographic in-stent late loss, defined as the difference between the post-procedural MLD and the follow-up MLD		at 6 months	No