Relation Among Shear Stress Distribution, Stent Design, and Subsequent Vessel Healing After Drug-eluting Stent Implantation (SHEAR DES)
Impact of Stent Platform on Shear Stress Distribution and Subsequent Vessel Healing After Drug-eluting Stent Implantation (SHEAR DES)
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to evaluate the differences of wall shear stress distribution among different types of drug-eluting stents and its impact on vessel healing evaluated by intravascular optical coherence tomography evaluation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 7, 2013
CompletedFirst Posted
Study publicly available on registry
September 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedSeptember 13, 2013
September 1, 2013
2 years
September 7, 2013
September 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of uncovered struts
8 months
Secondary Outcomes (6)
Neointimal thickness
8 months
The percentage of malapposed struts
8 months
Area of low wall shear stress
Baseline
Area of high oscillatory shear index
Baseline
Area of low wall shear stress
8 months
- +1 more secondary outcomes
Study Arms (3)
Promus element
EXPERIMENTALPromus element is a thin struts, 2-link design, evelolimus-eluting stents.
Xience Prime
ACTIVE COMPARATORXience Prime is a thin struts, 3-link design, evelolimus-eluting stents.
Nobori
ACTIVE COMPARATORNobori is a thick struts, 2-link design, biolimus-eluting stents.
Interventions
Eligibility Criteria
You may qualify if:
- Older than 20 years old.
- Indication of PCI with Xience prime, Nobori, or Promus element.
- Clinical diagnosis of stable angina, unstable angina or silent ischemia with reference vessel diameters ranging from 2.5-3.5mm.
- Underwent CT angiography before PCI.
- To agree to review and record all the clinical course in this research protocol.
You may not qualify if:
- Previous history of pancytopenia, liver function, renal dysfunction, hypersensitive history of the drug.
- Low ejection fraction (LVEF\<=30%), an impaired liver function, and renal dysfunction (eGFR\<=40)
- Severe calcification
- Stent restenosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kobe Universitylead
- Marquette Universitycollaborator
Study Sites (1)
Kobe University Graduate School of Medicine
Kobe, Hyōgo, 650-0017, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hiromasa Otake, MD, PhD
Kobe University Graduate School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 7, 2013
First Posted
September 13, 2013
Study Start
February 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
September 13, 2013
Record last verified: 2013-09