Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Abbott Vascular |
---|---|
Information provided by: | Abbott Vascular |
ClinicalTrials.gov Identifier: | NCT00596661 |
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.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Device: TriMaxx Coronary Stent placement |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study |
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. |
Enrollment: | 100 |
Study Start Date: | May 2004 |
Study Completion Date: | September 2005 |
Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
TRIMAXX: Experimental
TRIMAXX Coronary Stent
|
Device: TriMaxx Coronary Stent placement
Angioplasty with coronary artery stent placement
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
Instituto Dante Pazzanese de Cardiologia | |
Sao Paulo,, Brazil | |
Instituto Do Coracao do Triangolo Mineiro | |
Uberlandia, Brazil | |
Germany | |
Johannes Gutenberg Universitat | |
Mainz, Germany |
Principal Investigator: | Alexandre Abizaid, MD | Instituto Dante Pazzanese de Cardioloigia, Sao Paulo, Brazil |
Principal Investigator: | Jeffery J Popma, MD | Brigham and Women's Hospital. Boston, Massachusetts, USA |
Responsible Party: | Abbott Vascular ( Matt Kiely, Manager Medical Information ) |
Study ID Numbers: | AVD 640-0051-01 |
Study First Received: | January 9, 2008 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00596661 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research; Germany: Ethics Commission |
coronary stent |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |