Comparison of Titanium-Nitride-Oxide Coated Bio-Active-Stent (Optimax™) to the Drug (Everolimus) -Eluting Stent (Synergy™) in Acute Coronary Syndrome
NCT02049229 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1800
Last updated 2015-06-02
Summary
The purpose of the prospective, randomized and a multicenter trial is to compare clinical outcome in patients presenting with ACS, treated with PCI using Optimax-BAS versus Synergy-EES.
Second objective is to explore whether the Optimax-BAS use is superior compared with Synergy-EES use with respect of hard end points (cardiac death, MI and major bleeding).
Conditions
- Myocardial Infarction
- Percutaneous Coronary Intervention
- Atherosclerosis
Interventions
- DEVICE
-
percutaneous coronary intervention
Optimax-stent implantation
- DEVICE
-
percutaneous coronary intervention
Synergy stent implantation
Sponsors & Collaborators
-
The Hospital District of Satakunta
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2015-10-31
- Completion
- 2019-10-31
Countries
- Finland
Study Locations
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