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

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ClinicalTrials.gov Identifier: NCT02098876
Recruitment Status : Recruiting
First Posted : March 28, 2014
Last Update Posted : February 8, 2018
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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 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
Study Start Date : May 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. Coefficient of variance in neointimal hyperplasia [ Time Frame: 1 year ]
    Coefficient of variance in neointimal hyperplasia at 1 year following stent placement


Secondary Outcome Measures :
  1. Percent area of low wall shear stress [ Time Frame: Immediately after stent implantation ]
    The % area of low wall shear stress immediately after stent implantation

  2. N (%) uncovered and malopposed struts [ Time Frame: Immediately after stent implantation and at 1 year ]
    Number and percent of uncovered and malopposed struts



Information from the National Library of Medicine

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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 PCI
  3. Lesion treatable by a single Resolute Integrity or Abbott Xience Xpedition coronary drug eluting stent (length 15-38 mm).
  4. Evidence of myocardial ischemia (e.g., stable or unstable angina, post-infarct angina or silent ischemia) suitable for PCI.

Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective sign of ischemia as determined by echocardiogram, nuclear scan, ambulatory ECG or stress ECG. In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.

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. Recent (<3 days) ST-elevation myocardial infarction (STEMI)
  6. Systolic BP >160mmHg or diastolic BP>100 mmHg or hypotension (BP <90/60 mmHg)
  7. Planned surgical procedures in the subsequent 6 months
  8. History of hypersensitivity or contraindication to device materials and their degradants, everolimus, zotarolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers
  9. History of any solid organ transplantation or subject is on a waiting list for any solid organ transplant.
  10. Known allergies to clinically utilized anti-thrombotic or anti-platelet agents
  11. Unable to tolerate long term dual anti-platelet therapy
  12. Pregnancy or lactation
  13. Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min/1.73m2.

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


Contacts
Contact: Habib Samady, MD 404-712-7424 hsamady@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Habib Samady, MD    404-712-7424    hsamady@emory.edu   
Principal Investigator: Habib Samady, MD         
Sponsors and Collaborators
Emory University
Medtronic
Investigators
Principal Investigator: Habib Samady, MD Emory University

Responsible Party: Habib Samady, MD, FACC, FSCAI, Emory University
ClinicalTrials.gov Identifier: NCT02098876     History of Changes
Other Study ID Numbers: IRB00066353
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

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:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Glucuronyl glucosamine glycan sulfate
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents