NCT02098876

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
7 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 9, 2022

Completed
Last Updated

September 9, 2022

Status Verified

August 1, 2022

Enrollment Period

6.6 years

First QC Date

January 10, 2014

Results QC Date

June 30, 2022

Last Update Submit

August 16, 2022

Conditions

Coronary Artery Disease

Keywords

neointimal tissue areaangulated coronary vesselswall shear stresszotarolimus eluting stenteverolimus eluting stent

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • In Stent: Mean Thickness of Strut Coverage at Follow up

    1 year

  • 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)

    Immediately after stent implantation

  • In-Stent: Percent Area of Low Wall Shear Stress (WSS)-(In-Stent Mechanistic Endpoint)

    Immediately after stent implantation

  • Stent Edge -Change in Plaque Area (Efficacy Endpoint) at 5 mm Proximal and Distal to Stent.

    1 year

  • +2 more secondary outcomes

Study Arms (2)

Resolute Integrity DES

ACTIVE COMPARATOR

Resolute Integrity zotarolimus eluting stent

Device: Resolute Integrity Zotarolimus eluting stentDevice: Optical Coherence Tomography (OCT)Device: Intravascular Ultrasound (IVUS)

Xience Xpedition DES

ACTIVE COMPARATOR

Xience Xpedition everolimus eluting stent

Device: Xience Xpedition everolimus eluting stentDevice: Optical Coherence Tomography (OCT)Device: Intravascular Ultrasound (IVUS)

Interventions

Resolute Integrity Zotarolimus eluting stentDEVICE

PCI with Resolute stent

Resolute Integrity DES
Xience Xpedition everolimus eluting stentDEVICE

PCI with Xience stent

Xience Xpedition DES
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.

Resolute Integrity DESXience Xpedition DES
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.

Resolute Integrity DESXience Xpedition DES

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Emory University

Atlanta, Georgia, 30605, United States

Location

Nanjing Medical University, Nanjing Heart Center

Nanjing, 310006, China

Location

Kobe University Graduate School of Medicine

Hyōgo, 650-0017, Japan

Location

Wakayama Medical University Department of Cardiovascular Medicine

Wakayama, 641-8509, Japan

Location

Latvian Society of Cardiology Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

University Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Seoul National University College of Medicine

Seoul, 03080, South Korea

Location

Samsung Medical Center, Sungkyunkwan University School of Medicine Division of Cardiology

Seoul, 06351, South Korea

Location

Ulsan University Hospital University of Ulsan College of Medicine

Ulsan, 44033, South Korea

Location

Hospital Clinico San Carlos, Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

Related Publications (1)

  • 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.

    PMID: 41285658DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Tomography, Optical CoherenceUltrasonography, Interventional

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative TechniquesUltrasonographyMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Habib Samady
Organization
Northeast Georgia Health System
Habib.Samady@nghs.com
770-297-3549

Study Officials

  • Habib Samady, MD

    Georgia Heart Institute, Northeast Georgia Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 10, 2014

First Posted

March 28, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

September 9, 2022

Results First Posted

September 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(3)SE(1)ES(1)CN(1)JP(2)LA(1)US(1)