Clinical trial NCT01942044: Relation Among Shear Stress Distribution, Stent Design, and Subsequent Vessel Healing After Drug-eluting Stent Implantation (SHEAR DES)
Official title: Impact of Stent Platform on Shear Stress Distribution and Subsequent Vessel Healing After Drug-eluting Stent Implantation (SHEAR DES)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Heart Disease
Keywords: Shear stress
Optical coherence tomography
Drug-eluting stents
Lead sponsor: Kobe University
Sponsor class: INDUSTRY
Collaborators: name: Marquette University
First posted: 2013-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Background: Distribution of wall shear stress (WSS) may be different according to stent designs. The impact of WSS after stent implantation may impact future vessel healing after current generation drug-eluting stents implantation. Although previous studies used IVUS (intravascular ultrasound) and angiography to determine WSS from computational fluid dynamics (CFD) simulations, new methods using higher resolution OCT (optical coherence tomography) are warranted to further evaluate the impact of stent design on WSS with current generation drug-eluting stents.

Methods: For these purpose, we will enroll a total of 30 patients with stable angina who are scheduled for percutaneous coronary intervention. Those patients were randomized to thin-strut (81μm) 2-link Promus element (PE: n=10), thin-strut (81μm) 3-link Xience Prime (XP: n=10), or thick-strut (145μm) 2-link Nobori stents (NO: n=10) and underwent OCT and coronary CT angiography (CTA) after stenting. Post stent WSS was calculated using CFD simulations based on patient-specific reconstructed 3D arteries created by the fusion of OCT and CTA data, normalized using WSS in the proximal unstented region. Also, follow-up angiography and OCT are performed for the assessment of vessel healing as well as WSS distribution 8months after stent implantation.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of uncovered struts
timeFrame: 8 months
Secondary outcomes:
measure: Neointimal thickness
timeFrame: 8 months
measure: The percentage of malapposed struts
timeFrame: 8 months
measure: Area of low wall shear stress
timeFrame: Baseline
measure: Area of high oscillatory shear index
timeFrame: Baseline
measure: Area of low wall shear stress
timeFrame: 8 months
measure: Area of high oscillatory shear index
timeFrame: 8 months
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe University Graduate School of Medicine
state: Hyogo
Study officials:
affiliation: Kobe University Graduate School of Medicine
name: Hiromasa Otake, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: