Coronary Heart DiseasePhase 4NCT01942044
Relation Among Shear Stress Distribution, Stent Design, and Subsequent Vessel Healing After Drug-eluting Stent Implantation (SHEAR DES)
A Phase 4 study testing Promus element, Xience prime, and Nobori in people with Coronary Heart Disease, run by Kobe University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Promus element, Xience prime, and Nobori
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2013to Feb 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kobe University Graduate School of Medicine
Kobe, Hyōgo, 650-0017
Hiromasa Otake, MD, PhD, +81.78.382.5846, hotake@med.kobe-u.ac.jp
Toshiro Shinke, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Heart Disease
- Being tested
- Promus element, Xience prime, and Nobori
- Keywords
- Shear stress, Optical coherence tomography, Drug-eluting stents
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promus element, Xience prime, and NoboriDevice
| Study group | Role | What they receive |
|---|---|---|
| Promus element | Experimental | Promus element is a thin struts, 2-link design, evelolimus-eluting stents. Receives: Device: Promus element, Xience prime, and Nobori |
| Xience Prime | Active comparator | Xience Prime is a thin struts, 3-link design, evelolimus-eluting stents. Receives: Device: Promus element, Xience prime, and Nobori |
| Nobori | Active comparator | Nobori is a thick struts, 2-link design, biolimus-eluting stents. Receives: Device: Promus element, Xience prime, and Nobori |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of uncovered struts
Measured: 8 months
Secondary outcomes (6)
Neointimal thickness
Measured: 8 months
The percentage of malapposed struts
Measured: 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.
Measured: 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.
Measured: Baseline
Area of low wall shear stress
Measured: 8 months
Area of high oscillatory shear index
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kobe University
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Marquette University
- Responsible party
- Principal investigator, Hiromasa Otake, Kobe University
- Investigators
- Hiromasa Otake, MD, PhD, Principal investigator, Kobe University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942044
- Sponsor's protocol ID
- HOtake1
- Status last verified
- Sep 2013
- First submitted
- 7 Sep 2013
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Stent Platform on Shear Stress Distribution and Subsequent Vessel Healing After Drug-eluting Stent Implantation (SHEAR DES)
- ClinicalTrials.gov ID
- NCT01942044
- Acronym / sponsor ID
- HOtake1
- Conditions
- Coronary Heart Disease
- Keywords
- Shear stress, Optical coherence tomography, Drug-eluting stents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kobe UniversityIndustry (pharma, biotech, devices)
- Collaborators
- Marquette University
- Study start
- Feb 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Promus element | Experimental | Device: Promus element, Xience prime, and NoboriPromus element is a thin struts, 2-link design, evelolimus-eluting stents. |
| Xience Prime | Active comparator | Device: Promus element, Xience prime, and NoboriXience Prime is a thin struts, 3-link design, evelolimus-eluting stents. |
| Nobori | Active comparator | Device: Promus element, Xience prime, and NoboriNobori is a thick struts, 2-link design, biolimus-eluting stents. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promus element, Xience prime, and Nobori | Device | Nobori, Promus element, Xience Prime |
Primary outcome
Percentage of uncovered struts
Time frame: 8 months
6 secondary outcomes
Neointimal thickness
Time frame: 8 months
The percentage of malapposed struts
Time frame: 8 months
Area of low wall shear stress
Time frame: Baseline
Area of high oscillatory shear index
Time frame: Baseline
Area of low wall shear stress
Time frame: 8 months
Area of high oscillatory shear index
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiromasa Otake, MD, PhD principal investigator
Kobe University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Promus element, Xience prime, and Nobori in people with Coronary Heart Disease, run by Kobe University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hiromasa Otake, MD, PhD (+81.78.382.5846, hotake@med.kobe-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of uncovered struts (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2013.