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ILUMIEN IV: OPTIMAL PCI

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ClinicalTrials.gov Identifier: NCT03507777
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The objective of this 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Stenosis Atherosclerosis STEMI STEMI - ST Elevation Myocardial Infarction NSTEMI - Non-ST Segment Elevation MI Device: Coronary PCI guided by OCT Device: Coronary PCI guided by Angiography Not Applicable

Detailed Description:

This is a prospective, single-blind clinical investigation randomizing subjects to OCT-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio. The clinical investigation will be conducted at approximately 125 centers in North America (US and Canada), Europe, Middle East and Asia-Pacific.

All patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography group 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, 1 year, and 2 years.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3656 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2022

Arm Intervention/treatment
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.

Device: Coronary PCI guided by OCT
Stent implantation in high-risk or complex lesions in patients with coronary artery disease using OCT guidance
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.

Device: Coronary PCI guided by Angiography
Stent implantation in high-risk or complex lesions in patients with coronary artery disease using angiography guidance




Primary Outcome Measures :
  1. Minimal stent area (MSA) [ 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 an independent OCT core laboratory blinded to imaging modality assignment.

  2. Target vessel failure (TVF) [ Time Frame: Assessed at a minimum of 1 year and up to 2 years ]
    Composite time-to-first event rate of cardiac death, target vessel myocardial infarction (TV-MI) (per-protocol MI definition), or ischemia-driven target vessel revascularization (ID-TVR)


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

    MSA achieved in the proximal and distal stented segments relative to their respective reference lumen areas. The stent length is divided into 2 equal segments (proximal and distal) except for lesions containing a bifurcation (visually estimated side branch ≥2.5 mm). When there is a bifurcation present, rather than splitting the stent into two halves, the division is based upon the midpoint of the proximal most side branch.

    • Acceptable stent expansion (categorical variable): MSA of the proximal segment is ≥90% of the proximal reference lumen area and the MSA of the distal segment is ≥90% of the distal reference lumen area.
    • Unacceptable stent expansion (categorical variable): MSA of the proximal segment is <90% of the proximal reference lumen area, and/or the MSA of the distal segment is <90% of the distal reference lumen area.

  2. Mean stent expansion (%) (continuous variable) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    The mean stent area (stent volume/analysed stent length) divided by the average of proximal and distal reference lumen areas x 100

  3. 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.

  4. 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 focal disease with untreated Mean Lumen Area (MLA) <4.5 mm2 within 5 mm from the proximal and/or distal stent edges

  5. 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


  6. 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 associated with acceptable stent expansion

  7. Border detection (angiography arm post-PCI only, blinded to investigator) [ 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, after intervention and then classified into 3 grades:

    1. Good: ≥75% (270°) of visible circumference
    2. Moderate: ≥50% (180°) - <75% (270°) of visible circumference
    3. Poor: <50% (180°) of visible circumference

  8. 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 in secondary endpoint 3) (Intra-stent plaque protrusion and thrombus).

  9. 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)

  10. Angiographic Endpoints (QCA) - Final (post-PCI) minimal lumen diameter [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Final (post-PCI) minimal lumen diameter (Angiographic core laboratory assessed) Assessed per target lesion

  11. Angiographic Endpoints (QCA) - Final (post-PCI) percent diameter stenosis [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Final (post-PCI) percent diameter stenosis (Angiographic core laboratory assessed). Assessed per target lesion

  12. Angiographic Endpoints (QCA) - Acute lumen gain post-intervention [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Acute lumen gain post-intervention (Angiographic core laboratory assessed). Assessed per target lesion

  13. Angiographic Endpoints (QCA) - Maximum device size (stent or post-dilatation balloon)/reference vessel diameter ratio) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Maximum device size (stent or post-dilatation balloon)/reference vessel (Angiographic core laboratory assessed). Assessed per target lesiondiameter ratio

  14. Angiographic Endpoints (QCA) - Post-PCI target vessel Thrombolysis in Myocardial Infarction (TIMI) flow rate [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Post-PCI target vessel Thrombolysis in Myocardial Infarction (TIMI) flow rate (Angiographic core laboratory assessed). Assessed per target lesion

  15. Angiographic Endpoints (QCA) - Angiographic complications - worst (anytime during the procedure) and final (post PCI and all imaging) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Angiographic complications - worst (anytime during the procedure) and final (post PCI and all imaging) - Angiographic dissection ≥ NHLBI type B, perforations (Ellis classification), intra-procedural thrombotic events (including slow-flow, no-reflow, side branch closure, distal embolization, and intra-procedural stent thrombosis, as per the standard angiographic core laboratory definitions (Angiographic core laboratory assessed). Assessed per target lesion

  16. Device Usage - Total stent length [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Total stent length (site reported; assessed per subject)

  17. Device Usage - Total number of stents [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Total number of stents (site reported; assessed per subject)

  18. Device Usage - Maximal stent size [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Maximal stent size (site reported; assessed per subject)

  19. Device Usage - Post dilatation [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Post dilatation (yes/no) (site reported; assessed per subject)

  20. Device Usage - Total number of post-dilatation balloons [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Total number of post-dilatation balloons (site reported; assessed per subject)

  21. Device Usage - Maximal post-dilatation balloon size [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Maximal post-dilatation balloon size (site reported; assessed per subject)

  22. Device Usage - Maximal device size [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Maximal device size (stent or post-dilatation balloon) (site reported; assessed per subject)

  23. Device Usage - Maximum inflation pressure [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Maximum inflation pressure (atm.; stent or post-dilatation balloon) (site reported; assessed per subject)

  24. Procedure time [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    First wire insertion to guide catheter removal), fluoroscopy time, radiation exposure

  25. Contrast use [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    contrast induced nephropathy (defined as serum creatinine rise >25% or absolute increase >0.5 mg/dL); need for renal replacement therapy

  26. Procedural success (must be present in all treated lesions and vessels) [ 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) angiographic core laboratory-assessed final (post-PCI) lesion angiographic diameter stenosis <30% and target vessel TIMI III flow without any of the angiographic complications listed in 10(vi) above; plus B) the absence of site-assessed prolonged ST-segment elevation or depression (>30 minutes), cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, or procedural death

  27. Procedural complications [ 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) angiographic core laboratory-assessed complications listed in 10(vi) above occurring anytime during the procedure; or B) site-assessed prolonged ST-segment elevation or depression (>30 minutes), cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, or procedural death

  28. OCT performance success (site reported) (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 ]
    OCT imaging performed both pre- and post-PCI

  29. OCT imaging-related procedural complications (CEC adjudicated) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Any procedural complications (e.g. angiographic dissection, perforation, thrombus, acute closure, etc.) requiring any active intervention (e.g. prolonged balloon inflations, additional stent implantation, pericardiocentesis, intubation, hemodynamic support or pressors, defibrillation or cardioversion) or death adjudicated by the CEC as definitely or likely attributable to the physical performance of OCT-imaging (e.g. passing the catheter through the vasculature or stent, or injecting contrast to clear the blood for imaging). For this definition, adverse events that arise due to changes in PCI strategy as the result of OCT findings are NOT considered OCT imaging-related procedural complications

  30. Additional interventions on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone - Use of larger balloon [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Use of larger balloon (site reported; assessed per subject; OCT Arm Only)

  31. Additional interventions on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone - Use of higher inflation pressures [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Use of higher inflation pressures (site reported; assessed per subject; OCT Arm Only)

  32. Additional interventions on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone - Use of additional inflations [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Use of additional inflations (site reported; assessed per subject; OCT Arm Only)

  33. Additional interventions on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone - Use of additional stent(s) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Use of additional stent(s) (site reported; assessed per subject; OCT Arm Only)

  34. Additional interventions on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone - Thrombus aspiration [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Thrombus aspiration (site reported; assessed per subject; OCT Arm Only)

  35. Additional interventions on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone - Performance of atherectomy [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Performance of atherectomy (site reported; assessed per subject; OCT Arm Only)

  36. Additional interventions on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone - Other interventions [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Other interventions (site reported; assessed per subject; OCT Arm Only)

  37. Clinical outcomes - Target lesion failure (TLF; cardiac death, TV-MI or ischemia-driven target lesion revascularization (ID-TLR) [ Time Frame: Assessed at 30 days, 1 year and 2 years ]
    Target lesion failure (TLF; cardiac death, TV-MI or ischemia-driven target lesion revascularization (ID-TLR)

  38. Clinical outcomes - All-cause mortality [ Time Frame: Assessed at 30 days, 1 year and 2 years ]
    All-cause mortality

  39. Clinical outcomes - Cardiac and non-cardiac mortality [ Time Frame: Assessed at 30 days, 1 year and 2 years ]
    Cardiac and non-cardiac mortality

  40. Clinical outcomes - All myocardial infarction (MI) [ Time Frame: Assessed at 30 days, 1 year and 2 years ]
    All myocardial infarction (MI)

  41. Clinical outcomes - TV-MI and non-TV-MI [ Time Frame: Assessed at 30 days, 1 year and 2 years ]
    TV-MI and non-TV-MI

  42. Clinical outcomes - Periprocedural MI and non-periprocedural MI [ Time Frame: Assessed at 30 days, 1 year and 2 years ]
    Periprocedural MI and non-periprocedural MI

  43. Clinical outcomes - All revascularization [ Time Frame: Assessed at 30 days, 1 year and 2 years ]
    All revascularization

  44. Clinical outcomes - ID-revascularization and non-ID-revascularization [ Time Frame: Assessed at 30 days, 1 year and 2 years ]
    ID-revascularization and non-ID-revascularization

  45. Clinical outcomes - ID-TVR, ID-TLR and ID-non-TLR TVR [ Time Frame: Assessed at 30 days, 1 year and 2 years ]
    ID-TVR, ID-TLR and ID-non-TLR TVR

  46. Clinical outcomes - Definite, probable and definite/probable stent thrombosis (ARC definition) [ Time Frame: Assessed at 30 days, 1 year and 2 years ]
    Definite, probable and definite/probable stent thrombosis (ARC definition)

  47. Clinical outcomes - Relationship between immediate post-procedure OCT parameters and 2-year endpoint rates [ Time Frame: Assessed at 30 days, 1 year and 2 years ]
    Relationship between immediate post-procedure OCT parameters (e.g. MSA, procedural success, malapposition, dissection, protrusion, etc.) and 2-year endpoint rates (e.g. TVF, TLF, all-cause mortality, cardiac death, TV-MI, all MI, ID-TLR, ID-TVR, and stent thrombosis)

  48. Patient Reported Outcomes (PRO) [ Time Frame: Collected at 30 days, 1 year and 2 years ]
    to provide a complementary evaluation of the effectiveness of OCT-guided stent implantation. The EuroQoL 5D (EQ-5D-5L) survey will be used to assess overall health status

  49. Cost-effectiveness [ Time Frame: Assessed through 2 years ]
    Cost per quality adjusted life year (QALY) and TVF event prevented by OCT-guidance to be determined using standardized methods.

  50. Blinding/perception Analysis [ Time Frame: Assessed at discharge and 1 year ]
    The success of subject blinding and subjects' perceptions as to their assigned treatment will be assessed by a questionnaire at the time of discharge and at 1 year.



Information from the National Library of Medicine

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

Inclusion Criteria (all must be present)

  1. Subject must be at least 18 years of age.
  2. Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia, unstable angina, or acute myocardial infarction) suitable for elective PCI.
  3. 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

      1. 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;

      1. 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), and >1 mm ST-segment deviation and/or dynamic T wave changes at rest within 7 days, OR
        • STEMI >24 hours from the onset of ischemic symptoms
      2. long or multiple lesions (defined as intended total stent length in any single target vessel ≥28 mm),
      3. 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.
      4. angiographic severe calcification (defined as angiographically visible calcification on both sides of the vessel wall in the absence of cardiac motion),
      5. chronic total occlusion (CTO) (enrolment and randomization in this case performed only after successful antegrade wire escalation crossing and pre-dilatation)
      6. in-stent restenosis (all patterns, as long as the lesion is at or within the stent margin(s) and has an angiographically visually-assessed diameter stenosis (DS) ≥70% or DS ≥50% with non-invasive or invasive evidence of ischemia)
  4. 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 acute coronary syndrome (ACS) with plaque disruption or thrombus.
  5. 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. The only exception is for long target lesions (visually estimated as >20 mm), in which after implantation of a ≤3.5 mm stent up to half of the stented segment may be post-dilated with balloons >3.5 mm as needed per operator judgment.

    For example, if there is a 34 mm long Left Anterior Descending (LAD) lesion spanning the proximal and mid segments, a 38 mm long 3.0 mm diameter Xience stent may be implanted, and the proximal half of the stent may be post-dilated with a 3.75 mm balloon.

  6. 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.

  7. All target lesions intended to be treated by PCI in the target vessel are amenable to OCT-guided PCI (i.e. no lesion-specific angiographic exclusion criteria are present - see Section 5.4.2 below).

    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.

  8. For a female subject of childbearing potential, a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard, and pregnancy must not be intended for at least 2 years.
  9. For a female subject with a recent birth, subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 2 years following the index procedure.
  10. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure.

Clinical exclusion criteria:

  1. STEMI ≤24 hours from the onset of ischemic symptoms
  2. Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by the Modification of Diet in Renal Disease (MDRD) formula for estimated GFR) and not on dialysis. Note: chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance.
  3. Hypotension, shock or need for mechanical support or intravenous vasopressors
  4. Congestive Heart Failure (CHF) (Killip class ≥2 or New York Heart Association (NYHA) class ≥3)
  5. Left Ventricular Ejection Fraction (LVEF) ≤30% by the most recent imaging test within 30 days prior to procedure (echo, MRI, contrast left ventriculography or other)
  6. Unstable ventricular arrhythmias
  7. Inability to take dual antiplatelet therapy (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 coronary artery disease (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.
  8. Planned cardiac or non-cardiac surgery within 24 months after the index procedure
  9. Prior PCI within the target vessel within 12 months (unless the target lesion is the prior PCI site - i.e. in-stent restenosis)
  10. 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. See Section 6.5.3.7 for more details of multi lesion and vessel treatment.

    Note: PCI in non-target vessels is permitted >48 hours after the index procedure.

  11. 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% and TIMI III flow (visually assessed) for all non-target lesions and vessels, without dissection ≥ NHLBI type C, perforation, 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.

  12. Subject has known hypersensitivity or contraindication to any of the study drugs (including heparin and 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.
  13. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
  14. 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.
  15. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
  16. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
  17. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  18. 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.
  19. 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.).
  20. 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.
  21. Subject has life expectancy <2 years for any non-cardiac cause.
  22. Subject is in the opinion of the Investigator or designee unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
  23. Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint.
  24. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Angiographic exclusion criteria

  1. Syntax score ≥33, unless a formal meeting of the Heart Team, including a cardiac surgeon, concludes that PCI is appropriate.
  2. 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)
  3. Planned use of a stent or post-dilatation balloon ≥3.75 mm for the target lesion (see inclusion criteria #2 for the one exception to this exclusion criterion)
  4. 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)
  5. The target lesion is in the left main coronary artery
  6. 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.
  7. The target lesion is an ostial right coronary artery (RCA) stenosis
  8. The target lesion is a stent thrombosis
  9. Planned use of any stent other than Xience in a target lesion

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): NCT03507777


Contacts
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Contact: Mariah Tackett +1 818-493-2385 mariah.tackett@abbott.com
Contact: Kristina Gibbens kristina.gibbens@abbott.com

  Show 52 Study Locations
Sponsors and Collaborators
Abbott Medical Devices
Abbott
Investigators
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Study Chair: Gregg W Stone, MD NewYork-Presbyterian/Columbia University Medical Center
Principal Investigator: Ulf Landmesser, MD Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
Principal Investigator: Ziad A Ali, MD, DPhil NewYork-Presbyterian/Columbia University Medical Center

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03507777     History of Changes
Other Study ID Numbers: ABT-CIP-10233
SJM-CIP-10218 ( Other Identifier: Abbott Laboratories )
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Atherosclerosis
ST Elevation Myocardial Infarction
Coronary Stenosis
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases