ILUMIEN IV: OPTIMAL PCI

Not Applicable

• Conditions: Coronary Artery Disease

• Registration Number: JPRN-jRCT1032200080
• Lead Sponsor: Coe Jessie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3656

Inclusion Criteria

1. Subject must be at least 18 years of age.
2. 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.
3. 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),
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
4. 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.
5. 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.
6. 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.
7. All target lesions intended to be treated by PCI in the target vessel are amenable to OCT-guided PCI (i.e. no lesion-specific angiographic exclusion criteria are present).
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.
8. Subject must provide written Informed Consent prior to any study related procedure.

Exclusion Criteria

1. STEMI <=24 hours from the onset of ischemic symptoms
2. Creatinine clearance <=30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis.
3. Hypotension, shock or need for mechanical support or intravenous vasopressors at the time the patient would be undergoing the index procedure.
4. CHF (Killip class >=2 or NYHA class >=3)
5. LVEF <=30% by the most recent imaging test within 3 months prior to procedure. If no LVEF test result within 3 months is available, it must be assessed by echocardiography, multiple gated acquisition (MUGA), magnetic resonance imaging (MRI), ventriculography (LV gram) or other method.
6. Unstable ventricular arrhythmias
7. 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.
8. Planned major cardiac or non-cardiac surgery within 24 months after the index procedure
9. Prior PCI within the target vessel within 12 months
10. Any planned PCI within the target vessel(s) within 24 months after the study procedure, other than a planned staged intervention in a second randomized target vessel.
11. Any prior PCI in a non-target vessel within 24 hours before the study procedure, or within previous 30 days if unsuccessful or complicated.
12. 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, cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoropolymers, or radiocontrast dye that cannot be adequately pre-medicated.)
13. Subject has received a solid organ transplant which is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
14. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.).
15. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
16. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
17. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh >= Class B.
18. 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.
19. 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.).
20. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
21. Subject has life expectancy <2 years for any non-cardiac cause.
22. Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint .
23. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Minimal stent area (MSA) : Post-PCI MSA assessed by OCT in each randomized arm, measured at an independent OCT core laboratory blinded to imaging modality assignment.<br>- Target vessel failure (TVF): Composite time-to-first event rate of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR)