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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resolute Integrity DES | Active Comparator | Resolute Integrity zotarolimus eluting stent |
|
| Xience Xpedition DES | Active Comparator | Xience Xpedition everolimus eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resolute Integrity Zotarolimus eluting stent | Device | PCI with Resolute stent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 year |
| In-Stent: Degree of Vascular Straightening Post-percutaneous Coronary Intervention (PCI) (In-Stent Mechanistic Endpoint) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Habib Samady, MD | Georgia Heart Institute, Northeast Georgia Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30605 | United States | ||
| Nanjing Medical University, Nanjing Heart Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41285658 | Derived | 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. 2025 Nov 15:S1553-8389(25)00569-X. doi: 10.1016/j.carrev.2025.11.001. Online ahead of print. |
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Participants were recruited from 12 SITES. Participant enrollment began in May 2014 and all follow up was complete by December 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Resolute Integrity DES | Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 4, 2020 |
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| Xience Xpedition everolimus eluting stent |
| Device |
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. |
|
post PCI angulation by Angio: In-Stent: Degree of vascular straightening post-percutaneous coronary intervention (PCI) (In-Stent mechanistic endpoint) |
| 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) | 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) | 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 | 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 | 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). | Immediately after stent implantation |
| Nanjing |
| 310006 |
| China |
| Kobe University Graduate School of Medicine | Hyōgo | 650-0017 | Japan |
| Wakayama Medical University Department of Cardiovascular Medicine | Wakayama | 641-8509 | Japan |
| Latvian Society of Cardiology Pauls Stradins Clinical University Hospital | Riga | 1002 | Latvia |
| University Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Seoul National University College of Medicine | Seoul | 03080 | South Korea |
| Samsung Medical Center, Sungkyunkwan University School of Medicine Division of Cardiology | Seoul | 06351 | South Korea |
| Ulsan University Hospital University of Ulsan College of Medicine | Ulsan | 44033 | South Korea |
| Hospital Clinico San Carlos, Universidad Complutense de Madrid | Madrid | 28040 | Spain |
| FG001 | Xience Xpedition DES | Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent 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. 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Resolute Integrity DES | Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent 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. 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. |
| BG001 | Xience Xpedition DES | Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The numbers for each different endpoint are dependent on the data quality and availability for each endpoint. | Posted | Mean | Standard Deviation | mm^2 | 1 year |
|
|
| ||||||||||||||||||||||||||||
| Secondary | 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) | Posted | Mean | Standard Deviation | mm^2 | 1 year |
| |||||||||||||||||||||||||||||||
| Secondary | 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) | Posted | Mean | Standard Deviation | Degree | Immediately after stent implantation |
| |||||||||||||||||||||||||||||||
| Secondary | 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) | Posted | Mean | Standard Deviation | mm^2 | Immediately after stent implantation |
| |||||||||||||||||||||||||||||||
| Secondary | 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) | This outcome required that patients received computational fluid dynamics analysis, unfortunately, this was not possible in all patients. | Posted | Mean | Standard Deviation | percentage of area | Immediately after stent implantation |
| ||||||||||||||||||||||||||||||
| Secondary | 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 | The number of participants with images that are of adequate quality for analysis. The number reported corresponds to the actual change in plaque area between baseline and 1 year follow-up | Posted | Mean | Standard Deviation | mm^2 | 1 year |
| ||||||||||||||||||||||||||||||
| Secondary | 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 | This outcome only requires baseline angiograms hence more patients meet this criteria. | Posted | Mean | Standard Deviation | Degrees | Immediately after stent implantation |
| ||||||||||||||||||||||||||||||
| Secondary | 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). | This outcome required that patients received computational fluid dynamics analysis, unfortunately, this was not possible in all patients. | Posted | Mean | Standard Deviation | percentage of area | Immediately after stent implantation |
|
All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resolute Integrity DES | Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent 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. 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. | 0 | 45 | 2 | 45 | 0 | 45 |
| EG001 | Xience Xpedition DES | Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent 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. 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. | 0 | 41 | 2 | 41 | 2 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrent Chest Pain | Cardiac disorders | Systematic Assessment |
| ||
| Appendectomy | Gastrointestinal disorders | Systematic Assessment |
| ||
| Balloon Fracture | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unstable Angina | Cardiac disorders | Systematic Assessment |
| ||
| Target vessel revascularization | Surgical and medical procedures | Systematic Assessment |
| ||
| Chest pain | Cardiac disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Habib Samady | Northeast Georgia Health System | 770-297-3549 | Habib.Samady@nghs.com |
| Jun 6, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 10, 2015 | Jun 6, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| D018084 | Ultrasonography, Interventional |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
| D014463 | Ultrasonography |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Latvia |
|
| United States |
|
| China |
|
| Japan |
|
| Serbia |
|
| Spain |
|
Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent 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. 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. |
|
|
Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent 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. 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. |
|
|
Xience Xpedition everolimus eluting stent
Xience Xpedition everolimus eluting stent: PCI with Xience stent
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.
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.
|
|
| OG001 | Xience Xpedition DES | Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent 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. 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. |
|
|
| OG001 | Xience Xpedition DES | Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent 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. 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. |
|
|
| OG001 | Xience Xpedition DES | Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent 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. 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. |
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| OG001 | Xience Xpedition DES | Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent 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. 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. |
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