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OPTIMIZE PCI: Multicenter Randomized Trial of OCT Compared to IVUS and Angiography to Guide Coronary Stent Implantation (ILUMIEN III)

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ClinicalTrials.gov Identifier: NCT02471586
Recruitment Status : Completed
First Posted : June 15, 2015
Results First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
Cardiovascular Research Foundation, New York
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Coronary PCI guided by IVUS Procedure: Coronary PCI guided by OCT Procedure: Coronary PCI guided by Angiography Not Applicable

Detailed Description:

This is a prospective, post-market, international, multi-center, randomized clinical investigation in which the participants will be randomized in 1:1:1 ratio to undergo PCI with either OCT, IVUS, or Angiography guidance. The clinical investigation will be conducted at approximately 35 sites in the United States and outside the United States; approximately 25% of subjects will be enrolled in the United States.

Patients in the IVUS and OCT groups patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography group and IVUS groups will undergo a blinded post-PCI OCT run to allow comparison of OCT derived minimum stent area (MSA) in both groups.

After hospital discharge, all patients will have clinical follow-up at 30 days, and 1 year.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: For those subjects randomized to the IVUS or Angiography treatment arms, the operating investigator at the site was blinded to the final post-PCI OCT run for the subject.
Primary Purpose: Treatment
Official Title: ILUMIEN III: OPTIMIZE PCI: OPtical Coherence Tomography (OCT) Compared to Intravascular Ultrasound (IVUS) and Angiography to Guide Coronary Stent Implantation: a Multicenter RandomIZEd Trial in Percutaneous Coronary Intervention (PCI)
Actual Study Start Date : May 2015
Actual Primary Completion Date : April 5, 2016
Actual Study Completion Date : April 25, 2017

Arm Intervention/treatment
Active Comparator: Coronary PCI guided by IVUS

Intervention = Coronary stenting with planned drug eluting stent (DES).

Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation.

At the end of the procedure, a final IVUS imaging run must be performed.

After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results.

Procedure: Coronary PCI guided by IVUS
Imaging type
Other Name: Intravascular Ultrasound

Active Comparator: Coronary PCI guided by OCT

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.

Procedure: Coronary PCI guided by OCT
Imaging type
Other Name: Optical Coherence Tomography

Active Comparator: Coronary PCI guided by Angiography

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.

Procedure: Coronary PCI guided by Angiography
Imaging type




Primary Outcome Measures :
  1. Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA) [ Time Frame: Post-procedure within 1 hour ]

    Post-PCI MSA will be assessed by OCT in each randomized arm, measured at the independent OCT core laboratory blinded to imaging modality assignment. Hierarchal manner testing will be as follows:

    1. Non-inferiority: OCT vs. IVUS guided stenting

      Non-inferiority of OCT guided stenting to IVUS guided stenting will be analyzed for the mean difference between the post PCI MSA for the OCT and IVUS arms with non-inferiority margin of 1.0 mm^2.

    2. Superiority: OCT vs. Angiography guided stenting

      If the OCT guided stenting arm was found to be non-inferior to the IVUS guided stenting arm, the superiority of OCT to angiography will be tested for the mean difference between the post PCI MSA for the OCT and angiography arms.

    3. Superiority: OCT vs. IVUS guided stenting

    If the OCT guided stenting arm was found to be superior to the IVUS guided stenting arm, then the superiority of OCT to IVUS will be tested for the mean difference between the post PCI MSA for the OCT and IVUS arms.


  2. Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) [ Time Frame: During procedure, an average of 1 hour ]
    Procedural MACE defined as procedural complications (angiographic dissection, perforation, thrombus, and acute closure) requiring active interventions (prolonged balloon inflations, additional stent implantations, pericardiocentesis, thrombus aspiration and other).


Secondary Outcome Measures :
  1. Number of Participants With Acute Procedural Success [ Time Frame: During procedure, an average of 1 hour ]

    Acute procedural success are classified as:

    A) Optimal (%)

    The MSA of the proximal segment is ≥95% of the proximal reference lumen area and the MSA of the distal segment is ≥95% of the distal reference lumen area.

    B) Acceptable (%)

    The MSA of the proximal segment is ≥90% and <95% of the proximal reference lumen area and the MSA of the distal segment is ≥90% and <95% of the distal reference lumen area.

    C) Optimal and Acceptable (%)

    The MSA of the proximal segment is ≥90% and <95% of the proximal reference lumen area and the MSA of the distal segment is ≥90% and <95% of the distal reference lumen area.

    D) Unacceptable (%)

    The MSA of the proximal segment is <90% of the proximal lumen area, and/or the MSA of the distal segment is <90% of the distal reference lumen area.


  2. Rate of Post-PCI Stent Expansion (%) [ Time Frame: Up to 1 hour post-procedure ]
    Post-PCI stent expansion is defined as the minimum stent area divided by the average of proximal and distal reference lumen areas x 100.

  3. Rate of Mean Stent Expansion (%) [ Time Frame: During procedure, an average of 1 hour ]
    Mean stent expansion is defined as the mean stent area (stent volume/analyzed stent length) divided by the average of proximal and distal reference lumen areas x 100.

  4. Number of Participants With Plaque Protrusion and Thrombus [ Time Frame: During procedure, an average of 1 hour ]

    Plaque protrusion and thrombus is defined as a mass attached to the luminal surface or floating within the lumen, meeting the following criteria:

    Protrusion is defined as any mass at least 0.2 mm beyond the luminal edge of a strut and will be further classified as Major and Minor.

    Major: Protrusion area/Stent area at site of tissue protrusion ≥10%

    Minor: Protrusion area/Stent area at site of tissue protrusion<10%


  5. Number of Participants With Untreated Reference Segment Disease [ Time Frame: During procedure, an average of 1 hour ]
    Untreated reference segment disease is defined as untreated Mean Lumen Area (MLA) ≤60% of the adjacent reference segment lumen area up to 10 mm from the proximal and distal stent edges.

  6. Number of Participants With Edge Dissections [ Time Frame: During procedure, an average of 1 hour ]

    Edge Dissections are classified as

    A) Major (%): ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length

    B) Minor (%): any visible edge dissection <60 degrees of the circumference of the vessel and < 3 mm in length

    C) All (Major and Minor)

    Edge dissections will be further classified as:

    I. Intimal (limited to the intima layer, i.e. not extending beyond the internal elastic lamina)

    II. Medial (extending into the media layer)

    III. Adventitial (extending through the external elastic membrane


  7. Number of Participants With Stent Malapposition [ Time Frame: During procedure, an average of 1 hour ]

    Frequency (%) of incompletely apposed stent struts (defined as stent struts clearly separated from the vessel wall (lumen border/plaque surface) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch).

    Malapposition will be further classified as:

    Major: if associated with unacceptable stent expansion

    Minor: if not associated with significant under-expansion


  8. Number of Participants With Border Detection (OCT Arm Only) [ Time Frame: Pre-PCI OCT Run procedure ]

    The visibility of the vessel external elastic lamina (EEL) border by OCT will be evaluated at both reference sites (proximal and distal) and the MSA before AND after intervention and then classified into 3 grades:

    A) Good: ≥75% (270°) of visible circumference

    B) Moderate: ≥50% (180°) - <75% (270°) of visible circumference

    C) Poor: <50% (180°) of visible circumference


  9. Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run [ Time Frame: During procedure, an average of 1 hour ]
    Clinical decision making will be assessed on the basis of the post-stent imaging run

  10. Median Intra-stent Lumen Area (Intra-stent Flow Area) [ Time Frame: Up to 1 hour post-procedure ]
    Intra-stent Lumen Area (Intra-stent Flow Area) is defined as stent area minus any protrusion

  11. Median Effective Lumen Area (Total Flow Area) [ Time Frame: Up to 1 hour post-procedure ]
    Effective lumen area (Total flow area) is defined as Intra-stent Lumen Area plus any area of malapposition between the stent and the vessel wall (lumen border/plaque border).

  12. IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) [ Time Frame: During procedure, an average of 1 hour ]
    Dissection (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts

  13. IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) [ Time Frame: During procedure, an average of 1 hour ]
    Malapposition (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts

  14. IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) [ Time Frame: During procedure, an average of 1 hour ]
    Protrusion (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts

  15. Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter [ Time Frame: Baseline ]
    Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter

  16. Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter [ Time Frame: Final Post-PCI, up to 1 hour after PCI procedure ]
    Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter

  17. Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis [ Time Frame: Baseline ]
    Angiographic Endpoints (QCA) will be assessed as diameter stenosis

  18. Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis [ Time Frame: Final Post-PCI, up to 1 hour after PCI procedure ]
    Angiographic Endpoints (QCA) will be assessed as diameter stenosis

  19. Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention [ Time Frame: Final Post-PCI, up to 1 hour after PCI procedure ]
    Angiographic Endpoints (QCA) will be assessed as Acute lumen gain post-intervention

  20. Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio [ Time Frame: Baseline ]
    Angiographic Endpoints (QCA) will be assessed as Maximum stent size/reference vessel diameter ratio. Maximum stent size refers to the largest stent diameter used in a treated segment. If only one stent was used, it is that stent diameter. If more than one stent were used, it is the larger of the stent diameters.

  21. Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio [ Time Frame: Final Post-PCI, up to 1 hour after PCI procedure ]
    Angiographic Endpoints (QCA) will be assessed as Maximum stent size/reference vessel diameter ratio. Maximum stent size refers to the largest stent diameter used in a treated segment. If only one stent was used, it is that stent diameter. If more than one stent were used, it is the larger of the stent diameters.

  22. Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B [ Time Frame: Final Post-PCI, up to 1 hour after PCI procedure ]
    Angiographic Endpoints (QCA) will be assessed as Angiographic dissection ≥ NHLBI type B

  23. Procedural Endpoints (Site Reported): Median Total Stent Length [ Time Frame: During procedure, an average of 1 hour ]
    Median Total Stent Length will be measured in millimeters.

  24. Procedural Endpoints (Site Reported): Median Stents Per Lesion [ Time Frame: During procedure, an average of 1 hour ]
    Median Stents per lesion will be measured in counts

  25. Procedural Endpoints (Site Reported) - Median Maximal Stent Size [ Time Frame: During procedure, an average of 1 hour ]
    Median Maximal stent size will be measured in millimeters.

  26. Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations [ Time Frame: During procedure, an average of 1 hour ]
    Post dilatation inflations will be assessed in terms of use of balloon inflations

  27. Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.) [ Time Frame: During procedure, an average of 1 hour ]
    Median Maximum inflation pressure will be measured in atm.

  28. Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions [ Time Frame: During procedure, an average of 1 hour ]

    Participants will be analyzed for the use of additional inventions

    Additional interventions used on the basis of the post stent imaging run will be either use of Larger Balloon, Use of Higher Inflation Pressures, Use of Additional Inflations, Use of Additional Stent(s), Thrombus Aspiration, or Other Interventions


  29. Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate [ Time Frame: During procedure, an average of 1 hour ]
    Angiography defined procedural success rate is defined as a final lesion angiographic diameter stenosis <30% (QCA) and TIMI III flow (QCA) without dissection ≥ NHLBI type C, perforation, prolonged chest pain or ST segment elevation or depression changes (>30 minutes), or procedural death.

  30. Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate [ Time Frame: During procedure, an average of 1 hour ]

    Device success rate (site reported):

    Successful OCT or IVUS imaging obtained pre and post PCI in the respective arms (does not include blinded OCT runs in the IVUS and Angiography arms)


  31. Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF) [ Time Frame: 1 year ]

    Target Lesion Failure (TLF) at 1 year defined as cardiovascular death, target vessel myocardial infarction, or ischemia driven target-lesion revascularization.

    Target lesion is defined as the lesion designated for randomization to OCT vs. IVUS vs. Angiography.


  32. Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction [ Time Frame: 1 Year ]
    Number of Participants With Periprocedural Myocardial Infarction will be assessed at 1 year



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Patient with an indication for PCI including:

    • Angina (stable or unstable),
    • Silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present),
    • NSTEMI, or
    • Recent STEMI (>24 hours from initial presentation and stable).
  3. Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES)
  4. Signed written informed consent

Angiographic inclusion criteria:

  1. The target lesion must be located in a native coronary artery with visually estimated reference vessel diameter of ≥2.25 mm to ≤3.50 mm.
  2. Lesion length <40mm

General Exclusion Criteria:

  1. Estimated creatinine clearance <30 ml/min using Cockcroft-Gault equation, unless the patient is on dialysis
  2. STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital.
  3. PCI within 24 hours preceding the study procedure.
  4. PCI of a lesion within the target vessel within 12 months prior to the study procedure
  5. Planned use of bare metal stent (BMS)
  6. Planned use of bioresorbable vascular scaffold (BVS)
  7. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP, at time of procedure.
  8. Mobitz II second degree or complete heart block
  9. Malignant ventricular arrhythmias requiring treatment
  10. Pulmonary edema defined as patient with shortness of breath, evidence of volume overload on physical exam, and crepitations on physical exam (>1/3 of lungs) or radiographic interstitial or alveolar pulmonary edema
  11. Subject is intubated.
  12. Known LVEF <30%.
  13. Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis)
  14. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA.
  15. Presence of one or more co-morbidities which reduces life expectancy to less than 12 months or may interfere with protocol study processes.
  16. Known allergy to protocol-required concomitant medications including aspirin; clopidogrel, prasugrel, and ticagrelor; heparin and bivalirudin; or iodinated contrast that cannot be adequately pre-medicated.
  17. Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint.
  18. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before treatment).

Angiographic Exclusion Criteria:

  1. The presence of any non-study lesion in the target vessel with angiographic diameter stenosis >50%, or any additional target vessel stenosis which requires PCI either during or within 12 months after the study procedure
  2. Left main diameter stenosis ≥30% or left main PCI planned.
  3. Study target lesion in a bypass graft
  4. Ostial RCA study target lesion
  5. Chronic total occlusion (TIMI flow 0/1) study target lesion
  6. Bifurcation study lesion with a planned dual stent strategy
  7. In-stent restenosis study target lesion
  8. Any study lesion characteristic resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre and post PCI (e.g. moderate or severe vessel calcification or tortuosity)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471586


Locations
Show Show 29 study locations
Sponsors and Collaborators
Abbott Medical Devices
Cardiovascular Research Foundation, New York
Investigators
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Principal Investigator: Ziad Ali, MD Columbia Presbyterian Medical Center (NY)
Study Chair: Gregg W Stone, MD Columbia Presbyterian Medical Center (NY)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02471586    
Other Study ID Numbers: SJM-CIP-10034
First Posted: June 15, 2015    Key Record Dates
Results First Posted: April 1, 2021
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Abbott Medical Devices:
Percutaneous Coronary Intervention
Intravascular Ultrasound
Optical Coherence Tomography
SJM-CIP-10034
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases