Phase
Condition
Coronary Artery Disease
Cardiac Disease
Hypercholesterolemia
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-segment depression>1mmin ≥6 leads plus ST-segment elevation in aVR, life-threatening arrhythmias, mechanicalcomplications of MI, resuscitated cardiac arrest, GRACE risk score>140.
- All target lesions must be planned for treatment only in vessels with RVD ≥2.5 mm and ≤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 months inthe patient presenting with an ACS, or at least 6 months in the patient presentingwith stable CAD, unless the patient is also taking chronic oral anticoagulation inwhich case a shorter duration of DAPT may be prescribed per local standard 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 are removed,or normal anatomy is altered. Note: Minor surgery is an operation on the superficialstructures of the body or a manipulative procedure that does not involve a seriousrisk. 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 active ona waiting list for any solid organ transplants with expected transplantation within 24months.
- The subject receives immunosuppressant therapy or has known immunosuppressive orsevere autoimmune disease that requires chronic immunosuppressive therapy (e.g., humanimmunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids arenot 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 cirrhosis orChild-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 six months.The subject has had a cerebrovascular accident or transient ischemic neurologicalattack (TIA) within the past six months, or any prior intracranial bleed, or anypermanent neurologic defect, or any known intracranial pathology (e.g., aneurysm,arteriovenous malformation, etc. The subject has a life expectancy <2 years for anynon-cardiac cause.
- Subject is currently participating in another investigational drug or device clinicalstudy.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 yearsfollowing index procedure. Female subjects of child-bearing potential must have anegative pregnancy test done within 7 days prior to the index procedure per sitestandard 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
BelgiumActive - Recruiting
OLV Hospital
Aalst, 9300
BelgiumActive - Recruiting
Hartcentrum ZNA Antwerp
Antwerp, 2000
BelgiumActive - Recruiting
Gentofte hospital
Gentofte, Hellerup 2900
DenmarkActive - Recruiting
Aarhus Universitetshospital
Aarhus, 8200
DenmarkActive - Recruiting
Rigshospitalet
Copenhagen, 2100
DenmarkActive - Recruiting
Medical Imaging Centre, Semmelweis University
Budapest, 1082
HungaryActive - Recruiting
Humanitas University
Milan, 20090
ItalyActive - Recruiting
Ospedale Galeazzi Sant'Ambrogio
Milan, 20149
ItalyActive - Recruiting
Centro Cardiologico Monzino S.P.A.
Milano,
ItalyActive - Recruiting
Ospedale Molinette
Turin, 10126
ItalySite 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
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
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
United KingdomSite Not Available
Guy's and St Thomas' NHS Foundation Trust
London,
United KingdomSite Not Available
Freeman Hospital
Newcastle, NE7 7DN
United KingdomSite Not Available
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