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Completed

NCT Number: NCT02471586

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onze-Lieve-Vrouwziekenhuis Campus Aalst, Aalst, East Flanders, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

General Inclusion Criteria:

  • Age ≥ 18 years.
  • 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).
  • Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES)
  • Signed written informed consent

Angiographic inclusion criteria:

  • 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.
  • Lesion length <40mm

General Exclusion Criteria:

  • Estimated creatinine clearance <30 ml/min using Cockcroft-Gault equation, unless the patient is on dialysis
  • STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital.
  • PCI within 24 hours preceding the study procedure.
  • PCI of a lesion within the target vessel within 12 months prior to the study procedure
  • Planned use of bare metal stent (BMS)
  • Planned use of bioresorbable vascular scaffold (BVS)
  • 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.
  • Mobitz II second degree or complete heart block
  • Malignant ventricular arrhythmias requiring treatment
  • 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
  • Subject is intubated.
  • Known LVEF <30%.
  • Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis)
  • Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA.
  • Presence of one or more co-morbidities which reduces life expectancy to less than 12 months or may interfere with protocol study processes.
  • 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.
  • Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint.
  • 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:

  • 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
  • Left main diameter stenosis ≥30% or left main PCI planned.
  • Study target lesion in a bypass graft
  • Ostial RCA study target lesion
  • Chronic total occlusion (TIMI flow 0/1) study target lesion
  • Bifurcation study lesion with a planned dual stent strategy
  • In-stent restenosis study target lesion
  • 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)

Treatment and study plan

Coronary PCI guided by IVUS

Procedure

Imaging type

Other names: Intravascular Ultrasound

Coronary PCI guided by OCT

Procedure

Imaging type

Other names: Optical Coherence Tomography

Coronary PCI guided by Angiography

Procedure

Imaging type

Primary outcomes

  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:

    • 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.

    • 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.

    • 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • Cardiovascular Research Foundation, New York

Registry information

Official study 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)

Acronym: ILUMIEN III

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 15, 2015
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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