Clinical trial NCT00596661: The TRIMAXX Coronary Stent 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Artery Disease
Keywords: coronary stent
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Major Adverse Cardiac Events(MACE). MACE defined as Cardiac Death, MI(Q-wave and Non Q-wave) and Rarget Vessel Revascularization (TVR)
timeFrame: 30 Days
Secondary outcomes:
measure: Clinical Outcome: MACE
timeFrame: 6 months
measure: Clinical Outcome: Ischemia driven TVR
timeFrame: 6 months
measure: Clinical Outcome: Ischemia driven Target LesionRevascularization(TLR)
timeFrame: 6 months
measure: Clinical Outcome: Target Vessel Failure(TVF)
timeFrame: 6 months
measure: Angiographic Outcome: Device Success defined as achievment of a final residual in-stent stenosis > 30%(by QCA) using the assigned device only
timeFrame: procedural
measure: Angiographic Outcome: Lesion Success defined as attainment of a >30% residual in-stent stenosis (by QCA) using any percutaneous method
timeFrame: procedural
measure: 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.
timeFrame: hospital stay
measure: Angiographic Outcome: Angiographic in-stent and in-segment binary restenosis rate(>/= 50% diameter stenosis)
timeFrame: at 6 months
measure: Angiographic Outcome: In-stent, in-segment, proximal, and distal minimum lumen diameter(MLD))
timeFrame: at 6 months
measure: Angiographic Outcome: Angiographic in-stent late loss, defined as the difference between the post-procedural MLD and the follow-up MLD
timeFrame: at 6 months
Other outcomes:
Locations:
city: Sao Paulo,
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
city: Uberlandia
country: Brazil
facility: Instituto Do Coracao do Triangolo Mineiro
city: Mainz
country: Germany
facility: Johannes Gutenberg Universitat
Study officials:
affiliation: Instituto Dante Pazzanese de Cardioloigia, Sao Paulo, Brazil
name: Alexandre Abizaid, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital. Boston, Massachusetts, USA
name: Jeffery J Popma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.