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Wall Shear Stress and Neointimal Healing Following PCI in Angulated Coronary Vessels (SHEAR-STENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02098876
Recruitment Status : Completed
First Posted : March 28, 2014
Results First Posted : September 9, 2022
Last Update Posted : September 9, 2022
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Habib Samady, Emory University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Resolute Integrity Zotarolimus eluting stent Device: Xience Xpedition everolimus eluting stent Device: Optical Coherence Tomography (OCT) Device: Intravascular Ultrasound (IVUS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2014
Actual Primary Completion Date : December 2020
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arm Intervention/treatment
Active Comparator: Resolute Integrity DES
Resolute Integrity zotarolimus eluting stent
Device: Resolute Integrity Zotarolimus eluting stent
PCI with Resolute stent

Device: 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: 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.

Active Comparator: Xience Xpedition DES
Xience Xpedition everolimus eluting stent
Device: Xience Xpedition everolimus eluting stent
PCI with Xience stent

Device: 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: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. In Stent: Mean Thickness of Strut Coverage at Follow up [ Time Frame: 1 year ]
    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)

  2. In-Stent: Degree of Vascular Straightening Post-percutaneous Coronary Intervention (PCI) (In-Stent Mechanistic Endpoint) [ Time Frame: Immediately after stent implantation ]
    post PCI angulation by Angio: In-Stent: Degree of vascular straightening post-percutaneous coronary intervention (PCI) (In-Stent mechanistic endpoint)

  3. In Stent: Plaque Prolapse Post-PCI (In-Stent Mechanistic Endpoint) [ Time Frame: Immediately after stent implantation ]
    Plaque will be identified by Optical Coherence Tomography (OCT)- In-Stent: Plaque prolapse post-PCI (In-Stent mechanistic endpoint)

  4. In-Stent: Percent Area of Low Wall Shear Stress (WSS)-(In-Stent Mechanistic Endpoint) [ Time Frame: Immediately after stent implantation ]
    The % area of low wall shear stress immediately after stent implantation will be measured by Optical Coherence Tomography (OCT)

  5. Stent Edge -Change in Plaque Area (Efficacy Endpoint) at 5 mm Proximal and Distal to Stent. [ Time Frame: 1 year ]
    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

  6. 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 ]
    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

  7. Stent Edge: Percent Area With Low Wall Shear Stress (WSS) at Stent Edges Post-PCI (Mechanistic Endpoint) [ Time Frame: Immediately after stent implantation ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must be 30 to 80 years old
  2. Severe coronary lesion in a vessel with ≥ 30-degree angulation requiring percutaneous coronary intervention (PCI)
  3. Lesion treatable by a single Resolute Integrity or Onyx Abbott Xience Xpedition or Sierra coronary drug-eluting stent.
  4. Patients with stable ischemic heart disease or acute coronary syndrome undergoing clinically PCI.

Exclusion Criteria:

  1. Inability to provide informed consent prior to randomization
  2. Anatomy requiring coronary artery bypass surgery (CABG)
  3. History of prior CABG in the territory of the vessel being considered for PCI
  4. Heavily calcified lesion requiring rotablation or other debulking or scoring device for successful stent deployment
  5. Large thrombus burden on recent angiography
  6. Previously stented vessels
  7. 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)
  8. Lesions at bifurcations and those that occlude side branches >2.5mm
  9. Recent (<72 hours) ST-elevation myocardial infarction (STEMI).
  10. Planned surgical procedures in the subsequent 12 months
  11. History of hypersensitivity or contraindication to device materials and their degradants, everolimus, zotarolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoropolymers
  12. History of any solid organ transplantation or subject is on a waiting list for any solid organ transplant
  13. Left ventricular ejection fraction < 30%
  14. Known allergies to clinically utilized anti-thrombotic or anti-platelet agents
  15. Unable to tolerate long term dual antiplatelet therapy
  16. Pregnancy or lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098876


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30605
China
Nanjing Medical University, Nanjing Heart Center
Nanjing, China, 310006
Japan
Kobe University Graduate School of Medicine
Hyōgo, Japan, 650-0017
Wakayama Medical University Department of Cardiovascular Medicine
Wakayama, Japan, 641-8509
Korea, Republic of
Seoul National University College of Medicine
Seoul, Korea, Republic of, 03080
Samsung Medical Center, Sungkyunkwan University School of Medicine Division of Cardiology
Seoul, Korea, Republic of, 06351
Ulsan University Hospital University of Ulsan College of Medicine
Ulsan, Korea, Republic of, 44033
Latvia
Latvian Society of Cardiology Pauls Stradins Clinical University Hospital
Riga, Latvia, 1002
Serbia
University Clinical Center of Serbia
Belgrade, Serbia, 11000
Spain
Hospital Clinico San Carlos, Universidad Complutense de Madrid
Madrid, Spain, 28040
Sponsors and Collaborators
Emory University
Medtronic
Investigators
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Principal Investigator: Habib Samady, MD Georgia Heart Institute, Northeast Georgia Medical Center
  Study Documents (Full-Text)

Documents provided by Habib Samady, Emory University:
Informed Consent Form  [PDF] December 10, 2015

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Responsible Party: Habib Samady, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02098876    
Other Study ID Numbers: IRB00066353
First Posted: March 28, 2014    Key Record Dates
Results First Posted: September 9, 2022
Last Update Posted: September 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Habib Samady, Emory University:
neointimal tissue area
angulated coronary vessels
wall shear stress
zotarolimus eluting stent
everolimus eluting stent
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs