Relation Among Shear Stress Distribution, Stent Design, and Subsequent Vessel Healing After Drug-eluting Stent Implantation (SHEAR DES)

Coronary Heart Disease Clinical Trial

Official title:

Impact of Stent Platform on Shear Stress Distribution and Subsequent Vessel Healing After Drug-eluting Stent Implantation (SHEAR DES)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01942044
• Other study ID #: HOtake1
• Status: Recruiting
• Phase: Phase 4
• First received: September 7, 2013
• Last updated: September 10, 2013
• Start date: February 2013
• Est. completion date: February 2015

Study information

• Verified date: September 2013
• Source: Kobe University
• Contact: Hiromasa Otake, MD, PhD
• Phone: +81.78.382.5846
• Email: hotake[@]med.kobe-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Promus element, Xience prime, and Nobori

Locations

Country	Name	City	State
Japan	Kobe University Graduate School of Medicine	Kobe	Hyogo

Sponsors (2)

Lead Sponsor	Collaborator
Kobe University	Marquette University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of uncovered struts		8 months	Yes
Secondary	Neointimal thickness		8 months	No
Secondary	The percentage of malapposed struts		8 months	Yes
Secondary	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	No
Secondary	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	No
Secondary	Area of low wall shear stress		8 months	No
Secondary	Area of high oscillatory shear index		8 months	No