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)

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Device: Promus element, Xience prime, and Nobori

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hiromasa Otake, MD, PhD; Phone Number: +81.78.382.5846; Email: hotake@med.kobe-u.ac.jp

Study Locations

• Japan
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0017
      • Recruiting
      • Kobe University Graduate School of Medicine
      • Contact: Hiromasa Otake, MD, PhD; Phone Number: +81.78.382.5846; Email: hotake@med.kobe-u.ac.jp
      • Sub-Investigator: Toshiro Shinke, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Promus element; Promus element is a thin struts, 2-link design, evelolimus-eluting stents.	Device: Promus element, Xience prime, and Nobori
Active Comparator: Xience Prime; Xience Prime is a thin struts, 3-link design, evelolimus-eluting stents.	Device: Promus element, Xience prime, and Nobori
Active Comparator: Nobori; Nobori is a thick struts, 2-link design, biolimus-eluting stents.	Device: Promus element, Xience prime, and Nobori

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of uncovered struts	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neointimal thickness		8 months
The percentage of malapposed struts		8 months
Area of low wall shear stress	Baseline area of low wall shear stress will be calculated within 1 month after obtaining post stent OCT and CTA images.	Baseline
Area of high oscillatory shear index	Baseline area of high oscillatory shear index will be calculated within 1 month after obtaining post stent OCT and CTA images.	Baseline
Area of low wall shear stress		8 months
Area of high oscillatory shear index		8 months

Collaborators and Investigators

• Sponsor: Kobe University
• Collaborators: Marquette University
• Investigators: Principal Investigator: Hiromasa Otake, MD, PhD, Kobe University Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: September 7, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Estimate): September 13, 2013
• Last Update Submitted That Met QC Criteria: September 10, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Shear stress; Drug-eluting stents
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: HOtake1