Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets
NCT01670318 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800
Last updated 2012-08-22
Summary
Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left main trunk disease, and small vessel diseases is still unknown.
Conditions
Interventions
- DEVICE
-
platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)
Sponsors & Collaborators
-
The PCI Guideline Research Society
lead NETWORK
Principal Investigators
-
Yuji Oikawa, MD, PhD · The Cardiovascular Institute
-
Kenya Nasu, MD, FACC · Toyohashi Heart Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-08-31
- Primary Completion
- 2013-12-31
- Completion
- 2015-12-31
Countries
- Japan
Study Locations
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