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

NACompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2020

Conditions
Coronary Artery Disease
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.

Trial Locations (10)

1002

Latvian Society of Cardiology Pauls Stradins Clinical University Hospital, Riga

11000

University Clinical Center of Serbia, Belgrade

28040

Hospital Clinico San Carlos, Universidad Complutense de Madrid, Madrid

30605

Emory University, Atlanta

44033

Ulsan University Hospital University of Ulsan College of Medicine, Ulsan

310006

Nanjing Medical University, Nanjing Heart Center, Nanjing

650-0017

Kobe University Graduate School of Medicine, Hyōgo

641-8509

Wakayama Medical University Department of Cardiovascular Medicine, Wakayama

03080

Seoul National University College of Medicine, Seoul

06351

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medtronic

INDUSTRY

lead

Emory University

OTHER