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Coronary Artery DiseaseNCT03507777

ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)

A study testing Coronary PCI guided by OCT and Coronary PCI guided by Angiography in people with Coronary Artery Disease and Coronary Stenosis, run by Abbott Medical Devices at 90 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Coronary PCI guided by OCT and Coronary PCI guided by Angiography
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,487 participants
Where
90 sitesin 20 countries
Study dates
17 May 2018to 28 Feb 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be at least 18 years of age.
  • 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 undergoing planned XIENCE stent implantation during a clinically indicated PCI procedure meeting one or more of the following criteria:
  • High clinical-risk, defined as;
  • Medication-treated diabetes mellitus, AND/OR
  • 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;
Show all 25Show fewer
  • 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
  • long or multiple lesions (defined as intended total stent length in any single target vessel ≥28 mm),
  • Note: For a long target lesion, this would permit treatment by a single long stent or overlapping stents.
  • Note: For up to two target lesions located in a single target vessel and treated with non-overlapping stents, they may be located in a continuous vessel or split up between a main vessel and a side branch.
  • 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.
  • angiographic severe calcification (defined as angiographically visible calcification on both sides of the vessel wall in the absence of cardiac motion),
  • chronic total occlusion (CTO) (enrolment and randomization in this case performed only after successful antegrade wire escalation crossing and pre-dilatation)
  • 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
  • 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.
  • Note: For purposes of study eligibility, a minimum troponin of 1 ng/dL at the time of screening will be considered biomarker positive.
  • 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.
  • 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.
  • Note: A lesion is defined as any segment(s) of the coronary tree, no matter how long, which is planned to be covered with one contiguous length of stent, whether single or overlapped. A bifurcation counts as a single lesion even if the side branch is planned to be treated.
  • Note: All lesions in a randomized target vessel that are intended to be treated by PCI are designated as target lesions, and at least one target lesion in each randomized target vessel must meet angiographic high-risk inclusion criteria summarized above in 3B). The only exception is for patients who qualify for the trial on the basis of medication-treated diabetes, in which case no target lesion is required to meet angiographic high-risk inclusion criteria.
  • All target lesions intended to be treated by PCI in the target vessel are amenable to OCT-guided PCI.
  • 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.
  • Subject must provide written Informed Consent prior to any study related procedure.

Who cannot join

  • Clinical exclusion criteria:
  • STEMI ≤24 hours from the onset of ischemic symptoms
  • 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.
  • Hypotension, shock or need for mechanical support or intravenous vasopressors at the time the patient would be undergoing the index procedure.
  • CHF (Killip class ≥2 or NYHA class ≥3)
  • 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.
Show all 44Show fewer
  • Unstable ventricular arrhythmias
  • 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
  • Note: Prior PCI within the target vessel within 12 months is allowed for in-stent restenosis (target lesion is the prior PCI site) if no more than one layer of previously implanted stent is present.
  • Note: In-stent restenosis involving two or more layers of stent implanted at any time prior to index procedure (i.e. an earlier episode of in-stent restenosis previously treated with a second stent) is excluded.
  • 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.
  • Note: Planned staged interventions must be noted at the time of randomization, and the decision to stage may be modified within 24 hours of completion of the index PCI.
  • Note: PCI in non-target vessels is permitted >48 hours after the index procedure.
  • Any prior PCI in a non-target vessel within 24 hours before the study procedure, or within previous 30 days if unsuccessful or complicated.
  • Note: Patients requiring non-target vessel PCI may be enrolled and the non-target vessel(s) may be treated in the same index procedure as the randomized lesions (in all cases prior to randomization), as long as treatment of the lesion(s) in the non-target vessel is successful and uncomplicated.
  • Successful and uncomplicated definition for non-target vessel treatment during the index procedure: Angiographic diameter stenosis <10% for all treated non-target lesions, with TIMI III flow in this vessel, without final dissection ≥ NHLBI type B, perforation anytime during the procedure, prolonged chest pain (>5 minutes) or prolonged ST-segment elevation or depression (>5 minutes), or cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation).
  • 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.
  • 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.
  • 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.). Note: corticosteroids are not included as immunosuppressant therapy.
  • 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/mm^3 or >700,000 cells/mm^3.
  • Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  • 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.
  • 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.).
  • Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.
  • Subject has life expectancy <2 years for any non-cardiac cause.
  • Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint.
  • 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.
  • Angiographic exclusion criteria
  • Syntax score ≥33, unless a formal meeting of the Heart Team, including a cardiac surgeon, concludes that PCI is appropriate.
  • Planned use of any stent <2.5 mm in a target vessel based on visual estimation (note: a smaller stent may be used in a bail-out scenario - e.g. to treat a distal dissection - but its use cannot be planned prior to enrolment)
  • Planned use of a stent or post-dilatation balloon ≥3.75 mm for the target lesion
  • Severe vessel tortuosity or calcification in a target vessel such that it is unlikely that the OCT catheter can be delivered (note: severe vessel calcification is allowed if it is expected that the OCT catheter can be delivered at baseline or after vessel preparation with balloon pre-dilatation or atherectomy)
  • The target vessel has a lesion with DS ≥ 50% that is not planned for treatment at the time of index procedure.
  • The target lesion is in the left main coronary artery
  • The target lesion is in a bypass graft conduit. Note: A native coronary artery may be randomized if a prior bypass graft conduit to the vessel is totally occluded, but not if it is patent.
  • The target lesion is an ostial RCA stenosis
  • The target lesion is a stent thrombosis
  • Planned use of any stent other than Xience in a target lesion

Trial locations and contacts

90 sites in 20 countries.

90 sites in 20 countries

United States42 sites

  • Mission Health & Hospitals

    Asheville, North Carolina, 28801

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Austin Heart

    Austin, Texas, 78756

  • St. Charles Medical Center

    Bend, Oregon, 97701

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

    Birmingham, Alabama, 35233

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Buffalo General Hospital

    Buffalo, New York, 14203

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • John Muir Medical Center

    Concord, California, 94520

  • Providence Everett Medical Center

    Everett, Washington, 98201

  • The Cardiac & Vascular Institute Research Foundation, LLC

    Gainesville, Florida, 32605

  • Eastern Cardiology

    Greenville, North Carolina, 27833

  • Greenville Health System

    Greenville, South Carolina, 29401

  • Memorial Hermann Hospital

    Houston, Texas, 77030

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • Scripps Health

    La Jolla, California, 92037

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • St. Patrick Hospital

    Missoula, Montana, 59802

  • Centennial Heart Cardiovascular Consultants

    Nashville, Tennessee, 37203

  • New York Presbyterian Hospital/Columbia University

    New York, New York, 10032

  • McKay-Dee Heart Services

    Ogden, Utah, 84403

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97220

  • St. Francis Hospital

    Roslyn, New York, 11576

  • University of California - Davis Medical Center

    Sacramento, California, 95817

  • University of California at San Diego (UCSD) Medical Center

    San Diego, California, 92103

  • Scottsdale Healthcare Shea

    Scottsdale, Arizona, 85260

  • Swedish Medical Center

    Seattle, Washington, 98107

  • Stanford University Medical Center

    Stanford, California, 94305

  • Montefiore Medical Center - Moses Division

    The Bronx, New York, 10467

  • Lexington Medical Center

    West Columbia, South Carolina, 29169

  • Via Christi Regional Medical Center - St. Francis Campus

    Wichita, Kansas, 67214-3882

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226

  • University of Massachusetts Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Canada6 sites

  • QE II Health Sciences

    Halifax, Nova Scotia

  • Hamilton Health Science Centre

    Hamilton, Ontario

  • CHUM

    Montreal, Quebec

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec

  • Ottawa Heart Institute

    Ottawa, Ontario

  • Royal Jubilee Hospital

    Victoria, British Columbia

Other trials in Canada

Germany5 sites

  • Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

    Berlin, 12203

  • Kliniken der Friedrich-Alexander-Universitat

    Erlangen, Bavaria, 91054

  • Klinikum der Justus-Liebig-Universität

    Giessen, Hesse, 35392

  • UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

    Mainz, Rhinela, 55131

  • Deutsches Herzzentrum München des Freistaates Bayern

    Munich, Bavaria, 80636

Other trials in Germany

India4 sites

  • Postgraduate Institute of Medical Education & Research

    Chandigarh

  • Apollo Hospital

    Chennai, Tamil Nadu

  • The Madras Medical Mission

    Chennai, Tamil Nadu

  • Max Super Specialty Hospital

    New Delhi

Other trials in India

Italy4 sites

  • Ospedale Papa Giovanni XXIII

    Bergamo, Lombard, 20162

  • Centro Cardiologico Monzino

    Milan, Lombard

  • Policlinico Universitario A. Gemelli

    Rome, Lazio, 00168

  • Az. Osp. S. Giovanni Addolorata

    Rome, Lazio

Other trials in Italy

Australia3 sites

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Eastern Heart Clinic - Prince of Wales Hospital

    Randwick, 2031

Other trials in Australia

France3 sites

  • CHU de Besancon - Jean Minjoz

    Besançon, Franche-Comte, 25030

  • CHU Gabriel Montpied

    Clermont-Ferrand, Auvergn, 63000

  • Hopital Cardiovasculaire et Pneumologique Louis Pradel

    Lyon, Auvergne-Rhône-Alpes, 69394

Other trials in France

Hong Kong3 sites

  • Prince of Wales Hospital

    Hong Kong, HK SAR

  • Queen Elizabeth Hospital

    Hong Kong, HK SAR

  • Queen Mary Hospital

    Hong Kong, HK SAR

Other trials in Hong Kong

United Kingdom3 sites

  • Bristol Royal Infirmary

    Bristol, West Midland, BS2 8HW

  • Papworth Hospital NHS Foundation Trust

    Cambridge, CB2 0AY

  • Kings College Hospital

    London, SE5 9RS

Other trials in United Kingdom

Belgium2 sites

  • Onze-Lieve-Vrouwziekenhuis Campus Aalst

    Aalst, Eflndrs

  • UZ Gasthuisberg

    Leuven, Flemish Brabant, 3000

Other trials in Belgium

Netherlands2 sites

  • Albert Schweitzer Ziekenhuis

    Dordrecht, South Holland, 3318 AT

  • Maasstad Ziekenhuis

    Rotterdam, South Holland, 3079 DZ

Other trials in Netherlands

New Zealand2 sites

  • Christchurch Hospital

    Christchurch, Canterbury, 8001

  • Wellington Hospital

    Wellington, 6021

Other trials in New Zealand

Spain2 sites

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario de la Princesa

    Madrid

Other trials in Spain

Switzerland2 sites

  • Center Inselspital Bern

    Bern

  • Luzerner Kantonsspital

    Lucerne

Other trials in Switzerland

Taiwan2 sites

  • National Taiwan University Hospital

    Taipei, Ntaiwan

  • Taipei Veterans General Hospital (VGH)

    Taipei, Ntaiwan

Other trials in Taiwan

Denmark1 site

  • Skejby University Hospital

    Aarhus, 8200

Other trials in Denmark

Japan1 site

  • Wakayama Medical University

    Wakayama

Other trials in Japan

Portugal1 site

  • Hospital Santa Marta

    Lisbon, Lisbon District, 1169-024

Other trials in Portugal

Singapore1 site

  • National University Hospital

    Singapore, Central

Other trials in Singapore

Sweden1 site

  • Sahlgrenska University Hospital - Gothenburg

    Gothenburg, Vastra

Other trials in Sweden

About this study

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

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.

Being tested
Coronary PCI guided by OCT, Coronary PCI guided by Angiography
Keywords
ABT-CIP-10233, ILUMIEN OPTIS OCT Imaging System, Dragonfly, Optical Coherence Tomography (OCT), Coronary Stent IMplantation, Angiography
Medical subject headings
Coronary Artery Disease, Coronary Stenosis, Atherosclerosis, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary PCI guided by OCTDevice

    Also called Optical Coherence Tomography

    Stent implantation in high-risk or complex lesions in patients with coronary artery disease using OCT guidance

  • Coronary PCI guided by AngiographyDevice

    Stent implantation in high-risk or complex lesions in patients with coronary artery disease using angiography guidance

Study groups in NCT03507777
Study groupRoleWhat they receive
Coronary PCI guided by OCTActive comparatorIntervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed.
Receives: Device: Coronary PCI guided by OCT
Coronary PCI guided by AngiographyActive comparatorIntervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.
Receives: Device: Coronary PCI guided by Angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Imaging Outcome (Powered): Minimal Stent Area (MSA)

    Minimal Stent Area (per target lesion basis) assessed by OCT in each randomized arm, measured at an independent OCT core laboratory blinded to imaging modality assignment.

    Measured: Final Post-PCI Measurement (average of 24 hours).

  2. Number of Participants With Target Vessel Failure (TVF)

    Time-to-first event rate of the composite outcome of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR), will be assessed.

    Measured: At 2 years

Secondary outcomes (3)

  1. Number of Participants With Target Vessel Failure (TVF) Excluding Periprocedural MI (Powered)

    Time-to-first event rate of composite outcome of cardiac death, target vessel-related spontaneous myocardial infarction, or ischemia-driven target vessel revascularization (ID-TVR) will be assessed.

    Measured: At 2 years

  2. The Results of Adjudicated Clinical Outcomes to 2 Years in the Randomized Population

    The results of adjudicated clinical outcomes to 2 years in the randomized population by Kaplan-Meier assessment.

    Measured: 2 years

  3. The Number of Participants With Stent Thrombosis

    The results of adjudicated clinical outcomes to 2 years in the randomized population by Kaplan-Meier assessment.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2018
  2. Study start17 May 2018
  3. Primary completion28 Feb 2023
  4. Study completion28 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
2,487 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03507777
Sponsor's protocol ID
ABT-CIP-10233
Other IDs
SJM-CIP-10218
Status last verified
Jul 2024
First submitted
3 Apr 2018
Last updated
1 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Lopez JJ, Volleberg RHJA, Shin D, Janak E, Maehara A, Alfonso F, Mintz GS, Burzotta F, Gunasekaran S, McNutt R, Buccola J, Nie H, McGreevy R, Darki A, Landmesser U, Stone GW, Ali ZA; ILUMIEN IV Investigators. OCT-Defined Plaque Morphology and Clinical Outcomes After Percutaneous Coronary Intervention: An ILUMIEN IV Substudy. JACC Cardiovasc Imaging. 2026 Aug;19(8):970-980. doi: 10.1016/j.jcmg.2026.05.015.

    PubMed 42547197

  • Johnson TW, Bergmark BA, Croce K, Pellegrini D, Maehara A, Gori T, Pinilla-Echeverri N, Wollmuth J, Gonzalo N, Kao HL, Guagliumi G, Phalakornkule K, Ediebah D, McNutt J, Chiu WC, Op den Buijs J, Buccola J, Landmesser U, Ali Z, Stone GW, Jeremias A. Impact of Optical Coherence Tomography-Based Post-PCI Physiology Assessment to Predict Clinical Outcomes: An ILUMIEN-IV Substudy. J Am Coll Cardiol. 2025 Jul 15;86(2):93-102. doi: 10.1016/j.jacc.2025.05.019. Epub 2025 May 22.

    PubMed 40406943

  • Ali ZA, Landmesser U, Maehara A, Shin D, Sakai K, Matsumura M, Shlofmitz RA, Calligaris G, Maksoud A, Abdelwahed YS, Canova P, Gonzalo N, Alfonso F, Fall KN, Chehab B, McGreevy RJ, McNutt RW, Nie H, Wang J, Buccola J, Stone GW; ILUMIEN IV Investigators. Safety and Efficacy of Cobalt Chromium Everolimus-Eluting Stents for Treatment of In-Stent Restenosis: An ILUMIEN IV Substudy. J Am Heart Assoc. 2025 Jun 3;14(11):e039482. doi: 10.1161/JAHA.124.039482. Epub 2025 May 22.

    PubMed 40401609

  • Ali ZA, Landmesser U, Maehara A, Shin D, Sakai K, Matsumura M, Shlofmitz RA, Leistner D, Canova P, Alfonso F, Fabbiocchi F, Guagliumi G, Price MJ, Hill JM, Akasaka T, Prati F, Bezerra HG, Wijns W, McGreevy RJ, McNutt RW, Nie H, Phalakornkule K, Buccola J, Stone GW; ILUMIEN IV Investigators. OCT-Guided vs Angiography-Guided Coronary Stent Implantation in Complex Lesions: An ILUMIEN IV Substudy. J Am Coll Cardiol. 2024 Jul 23;84(4):368-378. doi: 10.1016/j.jacc.2024.04.037. Epub 2024 May 15.

    PubMed 38759907

  • Ali ZA, Landmesser U, Maehara A, Matsumura M, Shlofmitz RA, Guagliumi G, Price MJ, Hill JM, Akasaka T, Prati F, Bezerra HG, Wijns W, Leistner D, Canova P, Alfonso F, Fabbiocchi F, Dogan O, McGreevy RJ, McNutt RW, Nie H, Buccola J, West NEJ, Stone GW; ILUMIEN IV Investigators. Optical Coherence Tomography-Guided versus Angiography-Guided PCI. N Engl J Med. 2023 Oct 19;389(16):1466-1476. doi: 10.1056/NEJMoa2305861. Epub 2023 Aug 27.

    PubMed 37634188

  • Ali Z, Landmesser U, Karimi Galougahi K, Maehara A, Matsumura M, Shlofmitz RA, Guagliumi G, Price MJ, Hill JM, Akasaka T, Prati F, Bezerra HG, Wijns W, Mintz GS, Ben-Yehuda O, McGreevy RJ, Zhang Z, Rapoza RR, West NEJ, Stone GW. Optical coherence tomography-guided coronary stent implantation compared to angiography: a multicentre randomised trial in PCI - design and rationale of ILUMIEN IV: OPTIMAL PCI. EuroIntervention. 2021 Jan 20;16(13):1092-1099. doi: 10.4244/EIJ-D-20-00501.

    PubMed 32863246

Questions about this trial

What is this clinical trial studying?

A study testing Coronary PCI guided by OCT and Coronary PCI guided by Angiography in people with Coronary Artery Disease and Coronary Stenosis, run by Abbott Medical Devices at 90 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, Canada, Germany, India, Italy and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Imaging Outcome (Powered): Minimal Stent Area (MSA) (time frame: Final Post-PCI Measurement (average of 24 hours).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03507777, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.

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