OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI

Status: Completed
Location: See all (90) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this prospective, single-blind clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subject must be at least 18 years of age.

• Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for elective PCI.

• Patients undergoing planned XIENCE stent implantation during a clinically indicated PCI procedure meeting one or more of the following criteria:

• A) High clinical-risk, defined as;

• i. Medication-treated diabetes mellitus, AND/OR

• B) High angiographic-risk lesion(s), with at least one target lesion in each target vessel planned for randomization meeting at least one of the following criteria;

• i. Target lesion is the culprit lesion responsible for either:

⁃ NSTEMI, defined as a clinical syndrome consistent with an acute coronary syndrome and a minimum troponin of 1 ng/dL (may or may not have returned to normal), OR

⁃ STEMI \>24 hours from the onset of ischemic symptoms

• ii. long or multiple lesions (defined as intended total stent length in any single target vessel ≥28 mm),

• Note: For a long target lesion, this would permit treatment by a single long stent or overlapping stents.

• Note: For up to two target lesions located in a single target vessel and treated with non-overlapping stents, they may be located in a continuous vessel or split up between a main vessel and a side branch.

• iii. bifurcation intended to be treated with 2 planned stents (i.e. in both the main branch and side branch), and where the planned side branch stent is ≥ 2.5 mm in diameter by angiographic visual estimation.

• iv. angiographic severe calcification (defined as angiographically visible calcification on both sides of the vessel wall in the absence of cardiac motion),

• v. chronic total occlusion (CTO) (enrolment and randomization in this case performed only after successful antegrade wire escalation crossing and pre-dilatation)

• vi. in-stent restenosis of diffuse or multi-focal pattern. Lesion must be at or within the existing stent margin(s) and have angiographically visually-assessed DS ≥70% or DS ≥50% with non-invasive or invasive evidence of ischemia

• All target lesions (those lesions to be randomized) must have a visually estimated or quantitatively assessed %DS of either ≥70%, or ≥50% plus one or more of the following: an abnormal functional test (e.g. fractional flow reserve, stress test) signifying ischemia in the distribution of the target lesion(s) or biomarker positive ACS with plaque disruption or thrombus.

• Note: For purposes of study eligibility, a minimum troponin of 1 ng/dL at the time of screening will be considered biomarker positive.

• All target lesions must be planned for treatment with only ≥2.5 mm and ≤3.5 mm stents and post-dilatation balloons based on pre-PCI angiographic visual estimation.

• No more than 2 target lesions requiring PCI are present in any single vessel., and no more than 2 target vessels are allowed. Thus, up to 4 randomized target lesions per patient in a maximum of 2 target vessels are allowed, including branches. The intended target lesions will be declared just prior to randomization.

• Note: A lesion is defined as any segment(s) of the coronary tree, no matter how long, which is planned to be covered with one contiguous length of stent, whether single or overlapped. A bifurcation counts as a single lesion even if the side branch is planned to be treated.

• Note: All lesions in a randomized target vessel that are intended to be treated by PCI are designated as target lesions, and at least one target lesion in each randomized target vessel must meet angiographic high-risk inclusion criteria summarized above in 3B). The only exception is for patients who qualify for the trial on the basis of medication-treated diabetes, in which case no target lesion is required to meet angiographic high-risk inclusion criteria.

• All target lesions intended to be treated by PCI in the target vessel are amenable to OCT-guided PCI.

• Example: If a qualifying angiographic high-risk lesion is in the proximal LAD, and there is a second target lesion in the distal LAD which is a focal lesion not otherwise meeting high-risk criteria, both the proximal LAD and distal LAD lesions must be amenable to OCT (e.g. no excessive tortuosity or calcification precluding delivering the OCT catheter), and each lesion must undergo OCT-guided stenting. Otherwise the vessel should be excluded from randomization.

• Subject must provide written Informed Consent prior to any study related procedure.

Locations
United States
Alabama
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham
Arizona
Scottsdale Healthcare Shea
Scottsdale
California
Mills-Peninsula Medical Center
Burlingame
John Muir Medical Center
Concord
Scripps Health
La Jolla
Cedars-Sinai Medical Center
Los Angeles
University of California - Davis Medical Center
Sacramento
University of California at San Diego (UCSD) Medical Center
San Diego
Stanford University Medical Center
Stanford
Florida
The Cardiac & Vascular Institute Research Foundation, LLC
Gainesville
Georgia
Emory University Hospital
Atlanta
Piedmont Heart Institute
Atlanta
Illinois
Loyola University Medical Center
Maywood
Kansas
Kansas University Medical Center
Kansas City
Cardiovascular Research Institute of Kansas
Wichita
Via Christi Regional Medical Center - St. Francis Campus
Wichita
Kentucky
Baptist Health Lexington
Lexington
Massachusetts
Brigham & Women's Hospital
Boston
University of Massachusetts Medical Center
Worcester
Minnesota
Minneapolis Heart Institute
Minneapolis
Montana
St. Patrick Hospital
Missoula
North Carolina
Mission Health & Hospitals
Asheville
University of North Carolina at Chapel Hill
Chapel Hill
Eastern Cardiology
Greenville
New York
Montefiore Medical Center - Moses Division
Bronx
Buffalo General Hospital
Buffalo
North Shore University Hospital
Manhasset
New York Presbyterian Hospital/Columbia University
New York
St. Francis Hospital
Roslyn
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Oregon
St. Charles Medical Center
Bend
Providence St. Vincent Medical Center
Portland
Pennsylvania
Albert Einstein Medical Center
Philadelphia
University of Pittsburgh Medical Center
Pittsburgh
South Carolina
Greenville Health System
Greenville
Lexington Medical Center
West Columbia
Tennessee
Centennial Heart Cardiovascular Consultants
Nashville
Texas
Austin Heart
Austin
Memorial Hermann Hospital
Houston
Utah
McKay-Dee Heart Services
Ogden
Washington
Providence Everett Medical Center
Everett
Swedish Medical Center
Seattle
Other Locations
Australia
Fiona Stanley Hospital
Murdoch
Royal Perth Hospital
Perth
Eastern Heart Clinic - Prince of Wales Hospital
Randwick
Belgium
Onze-Lieve-Vrouwziekenhuis Campus Aalst
Aalst
UZ Gasthuisberg
Leuven
Canada
QE II Health Sciences
Halifax
Hamilton Health Science Centre
Hamilton
CHUM
Montreal
Hopital du Sacre-Coeur de Montreal
Montréal
Ottawa Heart Institute
Ottawa
Royal Jubilee Hospital
Victoria
Denmark
Skejby University Hospital
Arhus
France
CHU de Besancon - Jean Minjoz
Besançon
CHU Gabriel Montpied
Clermont-ferrand
Hopital Cardiovasculaire et Pneumologique Louis Pradel
Lyon
Germany
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin
Kliniken der Friedrich-Alexander-Universitat
Erlangen
Klinikum der Justus-Liebig-Universität
Giessen
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz
Deutsches Herzzentrum München des Freistaates Bayern
Munich
Hong Kong Special Administrative Region
Prince of Wales Hospital
Hong Kong
Queen Elizabeth Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
India
Postgraduate Institute of Medical Education & Research
Chandigarh
Apollo Hospital
Chennai
The Madras Medical Mission
Chennai
Max Super Specialty Hospital
New Delhi
Italy
Ospedale Papa Giovanni XXIII
Bergamo
Centro Cardiologico Monzino
Milano
Az. Osp. S. Giovanni Addolorata
Roma
Policlinico Universitario A. Gemelli
Roma
Japan
Wakayama Medical University
Wakayama
Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht
Maasstad Ziekenhuis
Rotterdam
New Zealand
Christchurch Hospital
Christchurch
Wellington Hospital
Wellington
Portugal
Hospital Santa Marta
Lisboa
Singapore
National University Hospital
Singapore
Spain
Hospital Clinico San Carlos
Madrid
Hospital Universitario de la Princesa
Madrid
Sweden
Sahlgrenska University Hospital - Gothenburg
Gothenburg
Switzerland
Center Inselspital Bern
Bern
Luzerner Kantonsspital
Luzern
Taiwan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital (VGH)
Taipei
United Kingdom
Bristol Royal Infirmary
Bristol
Papworth Hospital NHS Foundation Trust
Cambridge
Kings College Hospital
London
Time Frame
Start Date: 2018-05-17
Completion Date: 2023-02-28
Participants
Target number of participants: 2487
Treatments
Active_comparator: Coronary PCI guided by OCT
Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation.~At the end of the procedure, a final OCT imaging run must be performed.
Active_comparator: Coronary PCI guided by Angiography
Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with angiography guidance according to local standard practice.~At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.
Sponsors
Leads: Abbott Medical Devices
Collaborators: Abbott

This content was sourced from clinicaltrials.gov