CTRI/2020/09/027513
Active, not recruiting
Phase 4
OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI ILUMIEN IV- OPTIMAL PCI - ILUMIEN IV- OPTIMAL PCI
Abbott India Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: I708- Atherosclerosis of other arteriesHealth Condition 2: I214- Non-ST elevation (NSTEMI) myocardial infarctionHealth Condition 3: I212- ST elevation (STEMI) myocardial infarction of other sites
- Sponsor
- Abbott India Pvt Ltd
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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, 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;
- •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), and \>1 mm ST segment deviation and/or dynamic T wave changes at rest within 7 days, 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),
Exclusion Criteria
- •Clinical 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)5 and not on dialysis. Note: chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance.
- •3\. Hypotension, shock or need for mechanical support or intravenous vasopressors
- •4\. CHF (Killip class \>\=2 or NYHA class \>\=3\)
- •5\. LVEF \<\=30% by the most recent imaging test within 30 days prior to procedure (echo, MRI, contrast left ventriculography or other)
- •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 cardiac or non\-cardiac surgery within 24 months after the index procedure
- •9\. Prior PCI within the target vessel within 12 months (unless the target lesion is the prior PCI site \- i.e. in\-stent restenosis)
Outcomes
Primary Outcomes
Not specified
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