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Wall Shear Stress and Neointimal Healing Following PCI in Angulated Coronary Vessels

NCT02098876 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2022-09-09

Study results available
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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.

Conditions

Interventions

DEVICE

Resolute Integrity Zotarolimus eluting stent

PCI with Resolute 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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Habib Samady, MD · Georgia Heart Institute, Northeast Georgia Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States
  • China
  • Japan
  • Latvia
  • Serbia
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02098876 on ClinicalTrials.gov