Status:
RECRUITING
Precise Procedural and PCI Plan (P4)
Lead Sponsor:
CoreAalst BV
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Computed tomography (CT) has become an established tool in the diagnostic workup of patients with suspected coronary artery disease (CAD). The availability of coronary CT angiography (CCTA) before the...
Eligibility Criteria
Inclusion
- 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, silent ischemia (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 stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression\>1mm in ≥6 leads plus ST-segment elevation in aVR, life-threatening arrhythmias, mechanical complications 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 lesion even if the side branch is planned to be treated.
- Subject must provide written Informed Consent before any study-related procedure.
Exclusion
- 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 in the patient presenting with an ACS, or at least 6 months in the patient presenting with stable CAD, unless the patient is also taking chronic oral anticoagulation in which 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 index procedure Note: Major surgery is any invasive operative procedure in which an extensive 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 superficial structures of the body or a manipulative procedure that does not involve a 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 be adequately pre-medicated.
- The subject has received a solid organ transplant that is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
- The subject receives immunosuppressant therapy or has known immunosuppressive or severe 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 a coronary 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 or Child-Pugh ≥ Class B.
- The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, 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 device clinical study.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Unable to provide written informed consent (IC).
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05253677
Start Date
April 1 2022
End Date
October 1 2026
Last Update
December 28 2023
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
UZ Brussels
Jette, Brussels Capital, Belgium, 1090
2
OLV Hospital
Aalst, Belgium, 9300
3
Hartcentrum ZNA Antwerp
Antwerp, Belgium, 2000
4
Gentofte hospital
Gentofte Municipality, Hellerup, Denmark, 2900