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ILUMIEN III: OPTIMIZE PCI

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ClinicalTrials.gov Identifier: NCT02471586
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Cardiovascular Research Foundation, New York
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
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 trial.

Patients undergoing coronary angiography with possibility of PCI will be consented to participate in the study. Patients who provide informed consent and who meet all eligibility criteria will be randomized 1:1:1 to undergo PCI with either OCT, IVUS, or Angiography guidance.

All patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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)
Study Start Date : May 2015
Actual Primary Completion Date : April 5, 2016
Actual Study Completion Date : May 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) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

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

    1. Non-inferiority of OCT guided stenting to IVUS guided stenting


  2. Primary Efficacy Endpoint (powered) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

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

    2. Superiority of OCT guided stenting to Angiography guided stenting


  3. Primary Efficacy Endpoint (powered) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

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

    3. Superiority of OCT guided stenting to IVUS guided stenting


  4. Primary Safety Endpoint (non-powered) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Procedural MACE (Major Adverse Cardiac Event) defined as procedural complications (angiographic dissection, perforation, thrombus, and acute closure) requiring active interventions (prolonged balloon inflations, additional stent implantations, or pericardiocentesis).


Secondary Outcome Measures :
  1. Acute procedural success [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

    Acute procedural success A) Optimal (%) B) Acceptable (%) C) Unacceptable (%) D) Optimal and Acceptable (%)

    Defined by the MSA achieved relative to the proximal and distal reference segment.

    The stent length is divided into 2 equal segments (proximal and distal) and the MSA is determined in each segment.


  2. Post-PCI stent expansion (%) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Defined as the minimum stent area divided by the average of proximal and distal reference lumen areas x 100.

  3. Mean stent expansion (%) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    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. Intra-stent plaque protrusion and thrombus [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

    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.


  5. Untreated reference segment disease [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    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. Edge dissections [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    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)

  7. Stent Malapposition [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

    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. Border detection (OCT arm only) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

    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. Altered clinical decision making on the basis of the post-stent imaging run [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Altered clinical decision making on the basis of the post-stent imaging run

  10. Intra-stent Lumen Area (Intra-stent Flow Area) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Defined as stent area minus any protrusion as defined above.

  11. Effective Lumen Area (Total Flow Area) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    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 (IVUS Arm Only): Comparison to Blinded OCT Run (not-powered) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

    IVUS vs. OCT detected:

    A) Malapposition (Major, Minimal, All) (%)


  13. IVUS Secondary Endpoints (IVUS Arm Only): Comparison to Blinded OCT Run (not-powered) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

    IVUS vs. OCT detected:

    B) Dissection (Major, Minor, All) (%)


  14. IVUS Secondary Endpoints (IVUS Arm Only): Comparison to Blinded OCT Run (not-powered) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

    IVUS vs. OCT detected:

    C) Protrusion (Major, Minor, All) (%)


  15. Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

    Angiographic Endpoints (QCA)

    1) Minimal lumen diameter


  16. Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Angiographic Endpoints (QCA) 2) Percent diameter stenosis

  17. Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Angiographic Endpoints (QCA) 3) Acute lumen gain post-intervention

  18. Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Angiographic Endpoints (QCA) 4) Maximum stent size/reference vessel diameter ratio

  19. Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Angiographic Endpoints (QCA) 5) Angiographic dissection ≥ NHLBI type B

  20. Procedural Endpoints (site reported) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    1) Total stent length

  21. Procedural Endpoints (site reported) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    2) Total number of stents

  22. Procedural Endpoints (site reported) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    3) Maximal stent size

  23. Procedural Endpoints (site reported) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    4) Post dilatation inflations (yes/no)

  24. Procedural Endpoints (site reported) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    5) Maximum inflation pressure (atm.)

  25. Procedural Endpoints (site reported) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    6) Additional interventions on the basis of the post stent imaging run: A) Use of larger balloon B) Use of higher inflation pressures C) Use of additional inflations D) Use of additional stent(s) E) Thrombus aspiration F) Other interventions

  26. Additional Procedural and Clinical Endpoints [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    1) Angiography defined procedural success rate: 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.

  27. Additional Procedural and Clinical Endpoints [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    2) 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)

  28. Additional Procedural and Clinical Endpoints [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

    3) 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.


  29. Additional Procedural and Clinical Endpoints [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    4) Peri-procedural myocardial infarction.



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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 fractional flow reserve (FFR) ≤0.80 must be present),
    • Non-ST segment elevation myocardial infarction (NSTEMI), or
    • Recent ST segment elevation myocardial infarction (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 Note: Overlapping stents are allowed

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 Intra-aortic balloon pump (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 left ventricular ejection fraction (LVEF) <30%.
  13. Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis)
  14. Cerebrovascular accident ( CVA) 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

    Note: Patients may have non-study lesions in a non-target vessel that require PCI. These lesions must be treated prior to randomization, with the procedure being successful and uncomplicated. Alternatively non-study lesions in a non-target vessel may be treated >24 hours prior to or >48 hours after the study procedure.

    Successful and uncomplicated procedure is defined as <30% visually estimated residual diameter stenosis, Thrombolysis In Myocardial Infarction (TIMI) Grade 3 flow, no dissection ≥ National Heart, Lung and Blood Institute (NHLBI) type C, no perforation, no prolonged chest pain or ST segment elevation or depression (>30 minutes), no peri-procedural myocardial infarction (MI) as measured by creatine kinase-MB (CKMB) >5x upper limits of normal (ULN) or troponin >35x ULN.

  2. Left main diameter stenosis ≥30% or left main PCI planned.
  3. Study target lesion in a bypass graft
  4. Ostial right coronary artery (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


  Show 34 Study Locations
Sponsors and Collaborators
St. Jude Medical
Cardiovascular Research Foundation, New York
Investigators
Principal Investigator: Ziad Ali, MD Columbia Presbyterian Medical Center (NY)
Study Chair: Gregg Stone, MD Columbia Presbyterian Medical Center (NY)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02471586     History of Changes
Other Study ID Numbers: SJM-CIP-10034
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases