Phase
Condition
Vascular Diseases
Chest Pain
Coronary Artery Disease
Treatment
IVUS-guided PCI
CT-guided PCI
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The subject must be at least 18 years of age and younger than 80 years old.
Subject must have evidence of myocardial ischemia (e.g., stable angina, silentischemia (ischemia in the absence of chest pain or other anginal equivalents),unstable angina, or acute myocardial infarction) suitable for elective PCI.
Patients with a clinical indication for revascularization presenting with stablecoronary artery disease or stabilized acute coronary syndrome defined as followsunstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMIwithout high-risk features such as recurrence of chest pain, ST-segmentdepression>1mm in ≥6 leads plus ST-segment elevation in aVR, life-threateningarrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE riskscore>140.
All target lesions must be planned for treatment only in vessels with RVD ≥2.5 mmand ≤4.0 mm.
No more than 2 target vessels are allowed. A bifurcation counts as a single lesioneven if the side branch is planned to be treated.
Subject must provide written Informed Consent before any study-related procedure.
Exclusion
Exclusion Criteria:
Age <18 years or ≥80 years old
STEMI as clinical presentation.
Uncontrolled or recurrent ventricular tachycardia.
Hemodynamic instability.
Severe renal dysfunction, defined as an eGFR ≤30 mL/min/1.73 m2.
Atrial fibrillation, flutter, or arrhythmias.
Previous PCI or CABG.
The target lesion is in the left main coronary artery
BMI ≥35 kg/m2.
Insufficient CT quality assessed by the Core lab.
Comorbidity with life expectancy ≤ 2 years.
Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 monthsin the patient presenting with an ACS, or at least 6 months in the patientpresenting with stable CAD, unless the patient is also taking chronic oralanticoagulation in which case a shorter duration of DAPT may be prescribed per localstandard of care.
Planned major cardiac or non-cardiac surgery within 24 months after the indexprocedure Note: Major surgery is any invasive operative procedure in which anextensive resection is performed, e.g., a body cavity is entered, organs areremoved, or normal anatomy is altered. Note: Minor surgery is an operation on thesuperficial structures of the body or a manipulative procedure that does not involvea serious risk. Planned minor surgery is not excluded.
Prior PCI within the target vessel within 12 months.
Subject has known hypersensitivity or contraindication to any of the study drugs (including all P2Y12 inhibitors, one or more components of the study devices,including everolimus, zotarolimus, biolimus, sirolimus, cobalt, chromium, nickel,platinum, tungsten, acrylic, and fluoropolymers, or radiocontrast dye that cannot beadequately pre-medicated.
The subject has received a solid organ transplant that is functioning or is activeon a waiting list for any solid organ transplants with expected transplantationwithin 24 months.
The subject receives immunosuppressant therapy or has known immunosuppressive orsevere autoimmune disease that requires chronic immunosuppressive therapy (e.g.,human immunodeficiency virus, systemic lupus erythematosus, etc.). Note:corticosteroids are not included as immunosuppressant therapy.
The subject has previously received or is scheduled to receive radiotherapy to acoronary artery (vascular brachytherapy) or the chest/mediastinum.
Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
The subject has a documented or suspected hepatic disorder as defined as cirrhosisor Child-Pugh ≥ Class B.
The subject has a history of bleeding diathesis or coagulopathy or has had asignificant gastro-intestinal or significant urinary bleed within the past sixmonths. The subject has had a cerebrovascular accident or transient ischemicneurological attack (TIA) within the past six months, or any prior intracranialbleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy <2 years for any non-cardiac cause.
Subject is currently participating in another investigational drug or deviceclinical study.
Pregnant or nursing subjects and those who plan pregnancy in the period up to 2years following index procedure. Female subjects of child-bearing potential musthave a negative pregnancy test done within 7 days prior to the index procedure persite standard test.
Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation results.
Unable to provide written informed consent (IC).
Study Design
Connect with a study center
UZ Brussels
Jette, Brussels 1090
BelgiumSite Not Available
UZ Brussels
Jette 2794914, Brussels Capital 2800867 1090
BelgiumSite Not Available
OLV Hospital
Aalst, 9300
BelgiumSite Not Available
OLV Hospital
Aalst 2803448, 9300
BelgiumSite Not Available
Hartcentrum ZNA Antwerp
Antwerp, 2000
BelgiumSite Not Available
Hartcentrum ZNA Antwerp
Antwerp 2803138, 2000
BelgiumSite Not Available
Gentofte hospital
Gentofte, Hellerup 2900
DenmarkSite Not Available
Gentofte hospital
Gentofte Municipality 2621515, Hellerup 2900
DenmarkSite Not Available
Aarhus Universitetshospital
Aarhus, 8200
DenmarkSite Not Available
Aarhus Universitetshospital
Aarhus 2624652, 8200
DenmarkSite Not Available
Rigshospitalet
Copenhagen, 2100
DenmarkSite Not Available
Rigshospitalet
Copenhagen 2618425, 2100
DenmarkSite Not Available
Centre Hospitalier Universitaire de Lille
Lille 2998324, 59037
FranceSite Not Available
Medical Imaging Centre, Semmelweis University
Budapest, 1082
HungarySite Not Available
Medical Imaging Centre, Semmelweis University
Budapest 3054643, 1082
HungarySite Not Available
Azienda Ospedaliero Universitaria di Ferrara
Cona 8379290, 44124
ItalySite Not Available
Humanitas University
Milan, 20090
ItalySite Not Available
Ospedale Galeazzi Sant'Ambrogio
Milan, 20149
ItalyActive - Recruiting
Humanitas University
Milan 3173435, 20090
ItalySite Not Available
Ospedale Galeazzi Sant'Ambrogio
Milan 3173435, 20149
ItalySite Not Available
Centro Cardiologico Monzino S.P.A.
Milan 6951411,
ItalySite Not Available
Centro Cardiologico Monzino S.P.A.
Milano,
ItalySite Not Available
Ospedale Molinette
Turin, 10126
ItalySite Not Available
Aichi Medical University
Aichi 11192139,
JapanSite Not Available
Royal Bournemouth Hospital
Bournemouth, Dorset BH7 7DW
United KingdomSite Not Available
University Hospitals Dorset NHS Foundation Trust, Poole Hospital
Poole, Dorset BH15 2JB
United KingdomSite Not Available
University Hospitals Dorset NHS Foundation Trust, Poole Hospital
Poole 2640101, Dorset BH15 2JB
United KingdomSite Not Available
Oxford University Hospital NHS Foundation Trust
Headington, Oxford OX3 9DU
United KingdomSite Not Available
Golden Jubilee National Hospital
Clydebank, G81 4DY,
United KingdomSite Not Available
Golden Jubilee National Hospital
Clydebank 2652730, G81 4DY,
United KingdomSite Not Available
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
United KingdomSite Not Available
Liverpool Heart and Chest Hospital
Liverpool 2644210, L14 3PE
United KingdomSite Not Available
Guy's and St Thomas' NHS Foundation Trust
London,
United KingdomSite Not Available
Barts Health NHS Trust
London 2643743, E1 1FR
United KingdomSite Not Available
Guy's and St Thomas' NHS Foundation Trust
London 2643743,
United KingdomSite Not Available
St George's University Hospitals NHS Foundation Trust
London 2643743, ,SW17 0QT
United KingdomSite Not Available
Freeman Hospital
Newcastle, NE7 7DN
United KingdomSite Not Available
Freeman Hospital
Newcastle 6695976, NE7 7DN
United KingdomSite Not Available
Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
United StatesSite Not Available
Minneapolis Heart Institute Foundation
Minneapolis 5037649, Minnesota 5037779 55407
United StatesSite Not Available
St. Francis Hospital & Heart Center
Roslyn 5134415, New York 5128638 11576
United StatesSite Not Available

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