ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)

NCT03507777 | Completed Results DMC FDA Device

• 2 other identifiers: ABT-CIP-10233SJM-CIP-10218
• Study Type: interventional
• Target: 2,487
• Locations: 20 countries
• Sites: 90

Brief 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.

Conditions

Coronary Artery Disease; Coronary Stenosis; Atherosclerosis; STEMI; STEMI - ST Elevation Myocardial Infarction; NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)

Keywords

ABT-CIP-10233; ILUMIEN OPTIS OCT Imaging System; Dragonfly; Optical Coherence Tomography (OCT); Coronary Stent IMplantation; Angiography

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

  At 2 years

Secondary Outcomes (3)

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

  At 2 years

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

  2 years

• The Number of Participants With Stent Thrombosis

  2 years

Study Arms (2)

Coronary PCI guided by OCT

ACTIVE COMPARATOR

Intervention = 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.

Device: Coronary PCI guided by OCT

Coronary PCI guided by Angiography

ACTIVE COMPARATOR

Intervention = 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.

Device: Coronary PCI guided by Angiography

Interventions

Coronary PCI guided by OCT DEVICE

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

Also known as: Optical Coherence Tomography

Coronary PCI guided by OCT

Coronary PCI guided by Angiography DEVICE

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

Coronary PCI guided by Angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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),
• 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.
• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Abbott: collaborator

Study Sites (90)

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

Birmingham, Alabama, 35233, United States

Location

Scottsdale Healthcare Shea

Scottsdale, Arizona, 85260, United States

Location

Mills-Peninsula Medical Center

Burlingame, California, 94010, United States

Location

John Muir Medical Center

Concord, California, 94520, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California - Davis Medical Center

Sacramento, California, 95817, United States

Location

University of California at San Diego (UCSD) Medical Center

San Diego, California, 92103, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

The Cardiac & Vascular Institute Research Foundation, LLC

Gainesville, Florida, 32605, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, 67214-3882, United States

Location

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Medical Center

Worcester, Massachusetts, 01655, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

St. Patrick Hospital

Missoula, Montana, 59802, United States

Location

Buffalo General Hospital

Buffalo, New York, 14203, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

New York Presbyterian Hospital/Columbia University

New York, New York, 10032, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Montefiore Medical Center - Moses Division

The Bronx, New York, 10467, United States

Location

Mission Health & Hospitals

Asheville, North Carolina, 28801, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Eastern Cardiology

Greenville, North Carolina, 27833, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

St. Charles Medical Center

Bend, Oregon, 97701, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97220, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Greenville Health System

Greenville, South Carolina, 29401, United States

Location

Lexington Medical Center

West Columbia, South Carolina, 29169, United States

Location

Centennial Heart Cardiovascular Consultants

Nashville, Tennessee, 37203, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

McKay-Dee Heart Services

Ogden, Utah, 84403, United States

Location

Providence Everett Medical Center

Everett, Washington, 98201, United States

Location

Swedish Medical Center

Seattle, Washington, 98107, United States

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Eastern Heart Clinic - Prince of Wales Hospital

Randwick, 2031, Australia

Location

Onze-Lieve-Vrouwziekenhuis Campus Aalst

Aalst, Eflndrs, Belgium

Location

UZ Gasthuisberg

Leuven, Flemish Brabant, 3000, Belgium

Location

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Location

QE II Health Sciences

Halifax, Nova Scotia, Canada

Location

Hamilton Health Science Centre

Hamilton, Ontario, Canada

Location

Ottawa Heart Institute

Ottawa, Ontario, Canada

Location

CHUM

Montreal, Quebec, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

Location

Skejby University Hospital

Aarhus, 8200, Denmark

Location

Hopital Cardiovasculaire et Pneumologique Louis Pradel

Lyon, Auvergne-Rhône-Alpes, 69394, France

Location

CHU Gabriel Montpied

Clermont-Ferrand, Auvergn, 63000, France

Location

CHU de Besancon - Jean Minjoz

Besançon, Franche-Comte, 25030, France

Location

Kliniken der Friedrich-Alexander-Universitat

Erlangen, Bavaria, 91054, Germany

Location

Deutsches Herzzentrum München des Freistaates Bayern

Munich, Bavaria, 80636, Germany

Location

Klinikum der Justus-Liebig-Universität

Giessen, Hesse, 35392, Germany

Location

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, Rhinela, 55131, Germany

Location

Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, 12203, Germany

Location

Prince of Wales Hospital

Hong Kong, HK SAR, Hong Kong

Location

Queen Elizabeth Hospital

Hong Kong, HK SAR, Hong Kong

Location

Queen Mary Hospital

Hong Kong, HK SAR, Hong Kong

Location

Apollo Hospital

Chennai, Tamil Nadu, India

Location

The Madras Medical Mission

Chennai, Tamil Nadu, India

Location

Postgraduate Institute of Medical Education & Research

Chandigarh, India

Location

Max Super Specialty Hospital

New Delhi, India

Location

Policlinico Universitario A. Gemelli

Rome, Lazio, 00168, Italy

Location

Az. Osp. S. Giovanni Addolorata

Rome, Lazio, Italy

Location

Ospedale Papa Giovanni XXIII

Bergamo, Lombard, 20162, Italy

Location

Centro Cardiologico Monzino

Milan, Lombard, Italy

Location

Wakayama Medical University

Wakayama, Japan

Location

Albert Schweitzer Ziekenhuis

Dordrecht, South Holland, 3318 AT, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, South Holland, 3079 DZ, Netherlands

Location

Christchurch Hospital

Christchurch, Canterbury, 8001, New Zealand

Location

Wellington Hospital

Wellington, 6021, New Zealand

Location

Hospital Santa Marta

Lisbon, Lisbon District, 1169-024, Portugal

Location

National University Hospital

Singapore, Central, Singapore

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario de la Princesa

Madrid, Spain

Location

Sahlgrenska University Hospital - Gothenburg

Gothenburg, Vastra, Sweden

Location

Center Inselspital Bern

Bern, Switzerland

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

National Taiwan University Hospital

Taipei, Ntaiwan, Taiwan

Location

Taipei Veterans General Hospital (VGH)

Taipei, Ntaiwan, Taiwan

Location

Bristol Royal Infirmary

Bristol, West Midland, BS2 8HW, United Kingdom

Location

Papworth Hospital NHS Foundation Trust

Cambridge, CB2 0AY, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 40406943 DERIVED

• 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.

  PMID: 40401609 DERIVED

• 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.

  PMID: 38759907 DERIVED

• 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.

  PMID: 37634188 DERIVED

• 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.

  PMID: 32863246 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis; Atherosclerosis; ST Elevation Myocardial Infarction

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Results Point of Contact

• Title: Jana Buccola, Director Clinical Programs
• Organization: Abbott Vascular

jana.buccola@abbott.com

+1-408-845-1049

Study Officials

• Gregg W Stone, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

• Ulf Landmesser, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Ziad A Ali, MD, DPhil

  St Francis Hospital and Heart Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 25, 2018
• Study Start: May 17, 2018
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-07

Locations

NL (2); CH (2); IN (4); HK (3); JP (1); ES (2); SG (1); GB (3); NZ (2); BE (2); DK (1); US (42); AU (3); CA (6); IT (4); SE (1); TW (2); PT (1); FR (3); DE (5)