Coronary Artery DiseaseSHEAR-STENTNCT02098876
Wall Shear Stress and Neointimal Healing Following PCI in Angulated Coronary Vessels
A study testing Resolute Integrity Zotarolimus eluting stent, Xience Xpedition everolimus eluting stent and Optical Coherence Tomography (OCT) in people with Coronary Artery Disease, run by Emory University at 10 sites in 7 countries.
Trial summary
Stents are metallic tubular supports placed inside a blood vessel to relieve an obstruction and restore blood flow to the heart muscle. Stents could also be coated with a drug (drug-eluting stents - DES) that improves local healing and inhibits growth of scar tissue within the vessel that otherwise could lead to… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Resolute Integrity Zotarolimus eluting stent, Xience Xpedition everolimus eluting stent and Optical Coherence Tomography (OCT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 10 sitesin 7 countries
- Study dates
- May 2014to Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be 30 to 80 years old
- Severe coronary lesion in a vessel with ≥ 30-degree angulation requiring percutaneous coronary intervention (PCI)
- Lesion treatable by a single Resolute Integrity or Onyx Abbott Xience Xpedition or Sierra coronary drug-eluting stent.
- Patients with stable ischemic heart disease or acute coronary syndrome undergoing clinically PCI.
Who cannot join
- Inability to provide informed consent prior to randomization
- Anatomy requiring coronary artery bypass surgery (CABG)
- History of prior CABG in the territory of the vessel being considered for PCI
- Heavily calcified lesion requiring rotablation or other debulking or scoring device for successful stent deployment
- Large thrombus burden on recent angiography
- Previously stented vessels
Show all 16Show fewer
- Ostial lesions: lesion located within 5mm of the origin of the left anterior descending artery (LAD), left circumflex artery (LCx), or Right coronary artery (RCA)
- Lesions at bifurcations and those that occlude side branches >2.5mm
- Recent (<72 hours) ST-elevation myocardial infarction (STEMI).
- Planned surgical procedures in the subsequent 12 months
- History of hypersensitivity or contraindication to device materials and their degradants, everolimus, zotarolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoropolymers
- History of any solid organ transplantation or subject is on a waiting list for any solid organ transplant
- Left ventricular ejection fraction < 30%
- Known allergies to clinically utilized anti-thrombotic or anti-platelet agents
- Unable to tolerate long term dual antiplatelet therapy
- Pregnancy or lactation
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
South Korea3 sites
Seoul National University College of Medicine
Seoul, 03080
Samsung Medical Center, Sungkyunkwan University School of Medicine Division of Cardiology
Seoul, 06351
Ulsan University Hospital University of Ulsan College of Medicine
Ulsan, 44033
Japan2 sites
Kobe University Graduate School of Medicine
Hyōgo, 650-0017
Wakayama Medical University Department of Cardiovascular Medicine
Wakayama, 641-8509
Latvia1 site
Latvian Society of Cardiology Pauls Stradins Clinical University Hospital
Riga, 1002
Spain1 site
Hospital Clinico San Carlos, Universidad Complutense de Madrid
Madrid, 28040
About this study
Official title: Evaluation of WSS and Neointimal Healing Following Percutaneous Coronary Intervention of Angulated Vessels With Resolute® Integrity Zotarolimus Eluting Coronary Stent Compared to XIENCE Xpedition® Everolimus Eluting Coronary Stent
Stents are metallic tubular supports placed inside a blood vessel to relieve an obstruction and restore blood flow to the heart muscle. Stents could also be coated with a drug (drug-eluting stents - DES) that improves local healing and inhibits growth of scar tissue within the vessel that otherwise could lead to re-narrowing. This study will evaluate the effects of 2 FDA-approved metallic stents with different designs that may have important effects on regional plaque response and blood flow dynamics immediately after stent deployment and stent healing at 12 months follow up.
Read the detailed description
The past two decades have registered major advances in cardiovascular medicine that have improved patients' survival and quality of life. One area of major research and innovation is the field of percutaneous coronary interventions (PCI), a non-surgical procedure used to treat a narrowed heart artery with stents. Stents are metallic tubular supports placed inside a blood vessel to relieve an obstruction and restore blood flow to the heart muscle. Stents could also be coated with a drug (drug-eluting stents - DES) that improves local healing and inhibits growth of scar tissue (smooth muscle and fibrous cells) within the vessel that otherwise could lead to re-narrowing.
The investigators study will evaluate two FDA-approved DES, currently in use, with respect to coronary vessel healing and long term patency. These include the XIENCE Xpedition Everolimus drug-eluting stent (X-EES) from Abbott Vascular and Resolute Integrity® Zotarolimus drug-eluting stent (R-ZES) from Medtronic, Inc, both of which have been shown in large clinical trials to be safe and effective. This study will evaluate the effects of apparently subtle differences in stent design between these two platforms that may have important effects on regional plaque response and blood flow dynamics immediately after stent deployment and stent healing and scar formation at 12 months follow up.
Several aspect of the R-ZES compared to the X-EES design may result in more favorable regional plaque response and blood flow dynamics immediately after stent deployment. These include a more compliant stent design made of a single sinusoidal wire with no connector between struts that is likely to be more comformable to a curved or angulated coronary vessels. In heart vessels which are not angulated, these features may not make a major difference in outcomes as studies already suggest. Whereas, in narrowed arteries which are curved or angulated, the use of X-EES could result in more straightening of the vessel's natural curvature and more disturbance in flow patterns. In contrast, the use of R-ZES in angulated arteries could cause less hemodynamic disturbances. There is a great deal of data suggesting that disturbances in local blood flow patterns and creation of eddy currents ('turbulent' blood flow) could adversely affect stent healing and exacerbate neointimal tissue growth.
Using two intravascular imaging technologies, the optical coherence tomography (OCT) and intravascular ultrasound (IVUS), this study aims to investigate differences in scar tissue coverage within the stented region and the degree of narrowing at the edges of the stent in patients undergoing clinically-indicated PCI (with R-ZES and X-EES) at 12-month follow-up.
- Conditions
- Coronary Artery Disease
- Being tested
- Resolute Integrity Zotarolimus eluting stent, Xience Xpedition everolimus eluting stent, Optical Coherence Tomography (OCT), Intravascular Ultrasound (IVUS)
- Keywords
- neointimal tissue area, angulated coronary vessels, wall shear stress, zotarolimus eluting stent, everolimus eluting stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resolute Integrity Zotarolimus eluting stentDevice
PCI with Resolute stent
Xience Xpedition everolimus eluting stentDevice
PCI with Xience stent
Optical Coherence Tomography (OCT)Device
Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations.
Intravascular Ultrasound (IVUS)Device
Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.
| Study group | Role | What they receive |
|---|---|---|
| Resolute Integrity DES | Active comparator | Resolute Integrity zotarolimus eluting stent Receives: Device: Resolute Integrity Zotarolimus eluting stent; Device: Optical Coherence Tomography (OCT); Device: Intravascular Ultrasound (IVUS) |
| Xience Xpedition DES | Active comparator | Xience Xpedition everolimus eluting stent Receives: Device: Xience Xpedition everolimus eluting stent; Device: Optical Coherence Tomography (OCT); Device: Intravascular Ultrasound (IVUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
In Stent Mean Cross-sectional Area of Neo-intimal Tissue Coverage
Cross-sectional area in neointimal hyperplasia by Optical Coherence Tomography (OCT) at 1 year following stent placement
Measured: 1 year
Secondary outcomes (7)
In Stent: Mean Thickness of Strut Coverage at Follow up
Mean thickness of strut coverage at follow up (In-Stent safety endpoint). Struts have been considered as covered when tissue overlying the struts is >0 μm by optical coherence tomography (OCT)
Measured: 1 year
In-Stent: Degree of Vascular Straightening Post-percutaneous Coronary Intervention (PCI) (In-Stent Mechanistic Endpoint)
post PCI angulation by Angio: In-Stent: Degree of vascular straightening post-percutaneous coronary intervention (PCI) (In-Stent mechanistic endpoint)
Measured: Immediately after stent implantation
In Stent: Plaque Prolapse Post-PCI (In-Stent Mechanistic Endpoint)
Plaque will be identified by Optical Coherence Tomography (OCT)- In-Stent: Plaque prolapse post-PCI (In-Stent mechanistic endpoint)
Measured: Immediately after stent implantation
In-Stent: Percent Area of Low Wall Shear Stress (WSS)-(In-Stent Mechanistic Endpoint)
The % area of low wall shear stress immediately after stent implantation will be measured by Optical Coherence Tomography (OCT)
Measured: Immediately after stent implantation
Stent Edge -Change in Plaque Area (Efficacy Endpoint) at 5 mm Proximal and Distal to Stent.
Change in plaque area at the stent edges will be calculated from the change in plaque area in the 5 mm proximal and distal segments by intravascular ultrasound (IVUS); calculated as follow-up values minus baseline values
Measured: 1 year
Stent Edge: Degree of Vascular Straightening Post-percutaneous Coronary Intervention (PCI) at the Stent Edges (Stent Edge Mechanistic Endpoint)
Degree of vascular straightening post-percutaneous coronary intervention (PCI) at the stent edges (Stent Edge mechanistic endpoint) will be measured post PCI angulation by Angio
Measured: Immediately after stent implantation
Stent Edge: Percent Area With Low Wall Shear Stress (WSS) at Stent Edges Post-PCI (Mechanistic Endpoint)
The % area of low wall shear stress in the 5 mm proximal and distal segments immediately after stent implantation will be measured by intravascular ultrasound (IVUS).
Measured: Immediately after stent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Habib Samady, Emory University
- Investigators
- Habib Samady, MD, Principal investigator, Georgia Heart Institute, Northeast Georgia Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098876
- Sponsor's protocol ID
- IRB00066353
- Acronym
- SHEAR-STENT
- Status last verified
- Aug 2022
- First submitted
- 10 Jan 2014
- Last updated
- 9 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Molony DS, Hung O, Corban M, Gogas B, Lefieux A, Shah I, Komilian K, Adams A, Sykalo C, Dodoo S, Kumar A, Kumar S, Azarnoosh J, Piccinelli M, McDaniel MC, King SB, Maynard C, Chatzizisis YS, Chen SL, Shin ES, Stankovic G, Milasinovic D, Erglis A, Otake H, Akasaka T, Escaned J, Kwon-Koo B, Wook-Nam C, Won KB, Murasato Y, Lee WY, Lee SH, Hahn JY, Lee JM, Giddens DP, Veneziani A, Samady H. A randomized prospective study investigating the relationship between post-PCI wall shear stress and 12-month neointimal healing: The SHEAR-STENT study. Cardiovasc Revasc Med. 2026 Jul;88:57-65. doi: 10.1016/j.carrev.2025.11.001. Epub 2025 Nov 15.
PubMed 41285658
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of WSS and Neointimal Healing Following Percutaneous Coronary Intervention of Angulated Vessels With Resolute® Integrity Zotarolimus Eluting Coronary Stent Compared to XIENCE Xpedition® Everolimus Eluting Coronary Stent
- ClinicalTrials.gov ID
- NCT02098876
- Acronym / sponsor ID
- SHEAR-STENT / IRB00066353
- Conditions
- Coronary Artery Disease
- Keywords
- neointimal tissue area, angulated coronary vessels, wall shear stress, zotarolimus eluting stent, everolimus eluting stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Posted 9 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stents are metallic tubular supports placed inside a blood vessel to relieve an obstruction and restore blood flow to the heart muscle. Stents could also be coated with a drug (drug-eluting stents - DES) that improves local healing and inhibits growth of scar tissue within the vessel that otherwise could lead to re-narrowing. This study will evaluate the effects of 2 FDA-approved metallic stents with different designs that may have important effects on regional plaque response and blood flow dynamics immediately after stent deployment and stent healing at 12 months follow up.
Detailed description
The past two decades have registered major advances in cardiovascular medicine that have improved patients' survival and quality of life. One area of major research and innovation is the field of percutaneous coronary interventions (PCI), a non-surgical procedure used to treat a narrowed heart artery with stents. Stents are metallic tubular supports placed inside a blood vessel to relieve an obstruction and restore blood flow to the heart muscle. Stents could also be coated with a drug (drug-eluting stents - DES) that improves local healing and inhibits growth of scar tissue (smooth muscle and fibrous cells) within the vessel that otherwise could lead to re-narrowing.
The investigators study will evaluate two FDA-approved DES, currently in use, with respect to coronary vessel healing and long term patency. These include the XIENCE Xpedition Everolimus drug-eluting stent (X-EES) from Abbott Vascular and Resolute Integrity® Zotarolimus drug-eluting stent (R-ZES) from Medtronic, Inc, both of which have been shown in large clinical trials to be safe and effective. This study will evaluate the effects of apparently subtle differences in stent design between these two platforms that may have important effects on regional plaque response and blood flow dynamics immediately after stent deployment and stent healing and scar formation at 12 months follow up.
Several aspect of the R-ZES compared to the X-EES design may result in more favorable regional plaque response and blood flow dynamics immediately after stent deployment. These include a more compliant stent design made of a single sinusoidal wire with no connector between struts that is likely to be more comformable to a curved or angulated coronary vessels. In heart vessels which are not angulated, these features may not make a major difference in outcomes as studies already suggest. Whereas, in narrowed arteries which are curved or angulated, the use of X-EES could result in more straightening of the vessel's natural curvature and more disturbance in flow patterns. In contrast, the use of R-ZES in angulated arteries could cause less hemodynamic disturbances. There is a great deal of data suggesting that disturbances in local blood flow patterns and creation of eddy currents ('turbulent' blood flow) could adversely affect stent healing and exacerbate neointimal tissue growth.
Using two intravascular imaging technologies, the optical coherence tomography (OCT) and intravascular ultrasound (IVUS), this study aims to investigate differences in scar tissue coverage within the stented region and the degree of narrowing at the edges of the stent in patients undergoing clinically-indicated PCI (with R-ZES and X-EES) at 12-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resolute Integrity DES | Active comparator | Device: Resolute Integrity Zotarolimus eluting stent, Device: Optical Coherence Tomography (OCT), Device: Intravascular Ultrasound (IVUS)Resolute Integrity zotarolimus eluting stent |
| Xience Xpedition DES | Active comparator | Device: Xience Xpedition everolimus eluting stent, Device: Optical Coherence Tomography (OCT), Device: Intravascular Ultrasound (IVUS)Xience Xpedition everolimus eluting stent |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must be 30 to 80 years old
- Severe coronary lesion in a vessel with ≥ 30-degree angulation requiring percutaneous coronary intervention (PCI)
- Lesion treatable by a single Resolute Integrity or Onyx Abbott Xience Xpedition or Sierra coronary drug-eluting stent.
- Patients with stable ischemic heart disease or acute coronary syndrome undergoing clinically PCI.
Key exclusion criteria (16 listed)
- Inability to provide informed consent prior to randomization
- Anatomy requiring coronary artery bypass surgery (CABG)
- History of prior CABG in the territory of the vessel being considered for PCI
- Heavily calcified lesion requiring rotablation or other debulking or scoring device for successful stent deployment
- Large thrombus burden on recent angiography
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 |
|---|---|---|
| Resolute Integrity Zotarolimus eluting stentPCI with Resolute stent | Device | Resolute Integrity DES |
| Xience Xpedition everolimus eluting stentPCI with Xience stent | Device | Xience Xpedition DES |
| Optical Coherence Tomography (OCT)Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. | Device | Resolute Integrity DES, Xience Xpedition DES |
| Intravascular Ultrasound (IVUS)Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations. | Device | Resolute Integrity DES, Xience Xpedition DES |
Primary outcome
In Stent Mean Cross-sectional Area of Neo-intimal Tissue Coverage
Time frame: 1 year
Cross-sectional area in neointimal hyperplasia by Optical Coherence Tomography (OCT) at 1 year following stent placement
7 secondary outcomes
In Stent: Mean Thickness of Strut Coverage at Follow up
Time frame: 1 year
In-Stent: Degree of Vascular Straightening Post-percutaneous Coronary Intervention (PCI) (In-Stent Mechanistic Endpoint)
Time frame: Immediately after stent implantation
In Stent: Plaque Prolapse Post-PCI (In-Stent Mechanistic Endpoint)
Time frame: Immediately after stent implantation
In-Stent: Percent Area of Low Wall Shear Stress (WSS)-(In-Stent Mechanistic Endpoint)
Time frame: Immediately after stent implantation
Stent Edge -Change in Plaque Area (Efficacy Endpoint) at 5 mm Proximal and Distal to Stent.
Time frame: 1 year
Stent Edge: Degree of Vascular Straightening Post-percutaneous Coronary Intervention (PCI) at the Stent Edges (Stent Edge Mechanistic Endpoint)
Time frame: Immediately after stent implantation
Stent Edge: Percent Area With Low Wall Shear Stress (WSS) at Stent Edges Post-PCI (Mechanistic Endpoint)
Time frame: Immediately after stent implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41285658Molony DS, Hung O, Corban M, Gogas B, Lefieux A, Shah I, Komilian K, Adams A, Sykalo C, Dodoo S, Kumar A, Kumar S, Azarnoosh J, Piccinelli M, McDaniel MC, King SB, Maynard C, Chatzizisis YS, Chen SL, Shin ES, Stankovic G, Milasinovic D, Erglis A, Otake H, Akasaka T, Escaned J, Kwon-Koo B, Wook-Nam C, Won KB, Murasato Y, Lee WY, Lee SH, Hahn JY, Lee JM, Giddens DP, Veneziani A, Samady H. A randomized prospective study investigating the relationship between post-PCI wall shear stress and 12-month neointimal healing: The SHEAR-STENT study. Cardiovasc Revasc Med. 2026 Jul;88:57-65. doi: 10.1016/j.carrev.2025.11.001. Epub 2025 Nov 15.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Habib Samady, MD principal investigator
Georgia Heart Institute, Northeast Georgia Medical Center
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resolute Integrity Zotarolimus eluting stent, Xience Xpedition everolimus eluting stent and Optical Coherence Tomography (OCT) in people with Coronary Artery Disease, run by Emory University at 10 sites in 7 countries.
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 4 inclusion and 16 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: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea, Japan, United States, China, Latvia and 2 more countries. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In Stent Mean Cross-sectional Area of Neo-intimal Tissue Coverage (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02098876, which also lists 1 linked publication.
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 9 Sep 2022.