Loading clinical trials...

ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI) | Clinical Trials | Clareo Health

COMPLETEDNA

ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)

OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI

NCT03507777•Abbott Medical Devices

View on ClinicalTrials.gov

Summary

The objective of this prospective, single-blind clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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),
+14 more criteria

Exclusion Criteria

•1. STEMI ≤24 hours from the onset of ischemic symptoms
•2. Creatinine clearance ≤30 ml/min/1.73 m\^2 (as calculated by MDRD formula for estimated GFR) 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 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.
•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.
+32 more criteria

Locations (90)

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

Scottsdale Healthcare Shea

Scottsdale, Arizona, United States

Mills-Peninsula Medical Center

Burlingame, California, United States

John Muir Medical Center

Concord, California, United States

Scripps Health

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California - Davis Medical Center

Sacramento, California, United States

University of California at San Diego (UCSD) Medical Center

San Diego, California, United States

Stanford University Medical Center

Stanford, California, United States

The Cardiac & Vascular Institute Research Foundation, LLC

Gainesville, Florida, United States

Key Dates

Start Date

May 17, 2018

Primary Completion Date

February 28, 2023

Completion Date

February 28, 2023

Last Updated

August 1, 2024

Enrollment

2,487

ACTUAL participants

Conditions

Coronary Artery DiseaseCoronary StenosisAtherosclerosisSTEMISTEMI - ST Elevation Myocardial InfarctionNSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)

Interventions

Coronary PCI guided by OCT

DEVICE

Coronary PCI guided by Angiography

DEVICE

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

Metabolic DiseaseObesity+4 more

View study

RECRUITINGPHASE3

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

NCT07241390

Atherosclerosis Cardiovascular DiseaseChronic Kidney Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)

Inclusion Criteria

Exclusion Criteria

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

A Study of Implantation of CRENEOUS ENTERPRISE 2 Intracranial Stent in Participants With Severe Symptomatic Intracranial Atherosclerotic Stenosis

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

Machine Learning for Handheld Vascular Studies

"Erectile Function After PCI in MI and Non-MI Patients"