Trials / Completed
CompletedNCT02280720
Vascular Healing After Deployment of Titanium-nitride-oxide-coated OPTIMAX™ Stent and PROMUS-ELEMENT™ Everolimus-Eluting Stent
A Randomized Prospective Multicenter Trial to Compare Vascular Healing and Vasodilation at 2 Months After Deployment of TItanium-nitride-oxide-coated OPTIMAX™ Stent and PROMUS-ELEMENT™ Drug-Eluting Stent in Patients With Acute Coronary Syndromes by Means of Optical Coherence Tomography and Coronary Flow Reserve
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- The Hospital District of Satakunta · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare vascular healing of the stented segment after deployment of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent stent and Promus-Element™ everolimus-eluting stent in patients with acute coronary syndromes requiring percutaneous coronary intervention. 1. Comparison of OCT and CFR findings of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent and Promus-Element™ everolimus-eluting stent at two months after the index procedure. 2. Comparison of intravascular coronary flow reserve measurement to non-invasive transthoracic echocardiography-derived coronary flow reserve measurement. 3. Comparison of epicardial vasodilation to coronary microcirculatory vasodilation
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Stenting using Optimax™ | |
| PROCEDURE | Stenting using PROMUS Element™ Plus |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2013-12-01
- Completion
- 2014-01-01
- First posted
- 2014-10-31
- Last updated
- 2014-10-31
Locations
4 sites across 1 country: Finland
Source: ClinicalTrials.gov record NCT02280720. Inclusion in this directory is not an endorsement.