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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03507777




Registration number
NCT03507777
Ethics application status
Date submitted
3/04/2018
Date registered
25/04/2018
Date last updated
9/06/2023

Titles & IDs
Public title
ILUMIEN IV: OPTIMAL PCI
Scientific title
OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI
Secondary ID [1] 0 0
SJM-CIP-10218
Secondary ID [2] 0 0
ABT-CIP-10233
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Coronary Stenosis 0 0
Atherosclerosis 0 0
STEMI 0 0
STEMI - ST Elevation Myocardial Infarction 0 0
NSTEMI - Non-ST Segment Elevation MI 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Coronary PCI guided by OCT
Treatment: Devices - Coronary PCI guided by Angiography

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.

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.


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

Treatment: Devices: Coronary PCI guided by Angiography
Stent implantation in high-risk or complex lesions in patients with coronary artery disease using angiography guidance
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Imaging Outcome (Powered): Mean change in Minimal stent area (MSA), continuous measure
Timepoint [1] 0 0
Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Primary outcome [2] 0 0
Clinical outcome (Powered): Rate of Target vessel failure (TVF)
Timepoint [2] 0 0
At 2 years
Secondary outcome [1] 0 0
Rate of Target vessel failure (TVF) excluding periprocedural MI (Powered)
Timepoint [1] 0 0
At 2 years

Eligibility
Key inclusion 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 (ischemia in the absence of chest pain or other anginal equivalents),
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:

A) High clinical-risk, defined as;

i. Medication-treated diabetes mellitus, AND/OR

B) High angiographic-risk lesion(s), with at least one target lesion in each target
vessel planned for randomization meeting at least one of the following criteria;

i. Target lesion is the culprit lesion responsible for either:

- NSTEMI, defined as a clinical syndrome consistent with an acute coronary syndrome
and a minimum troponin of 1 ng/dL (may or may not have returned to normal), OR

- STEMI >24 hours from the onset of ischemic symptoms

ii. long or multiple lesions (defined as intended total stent length in any single
target vessel =28 mm),

Note: For a long target lesion, this would permit treatment by a single long stent or
overlapping stents.

Note: For up to two target lesions located in a single target vessel and treated with
non-overlapping stents, they may be located in a continuous vessel or split up between
a main vessel and a side branch.

iii. bifurcation intended to be treated with 2 planned stents (i.e. in both the main
branch and side branch), and where the planned side branch stent is = 2.5 mm in
diameter by angiographic visual estimation.

iv. angiographic severe calcification (defined as angiographically visible
calcification on both sides of the vessel wall in the absence of cardiac motion),

v. chronic total occlusion (CTO) (enrolment and randomization in this case performed
only after successful antegrade wire escalation crossing and pre-dilatation)

vi. in-stent restenosis of diffuse or multi-focal pattern. Lesion must be at or within
the existing stent margin(s) and have angiographically visually-assessed 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 ACS with
plaque disruption or thrombus.

Note: For purposes of study eligibility, a minimum troponin of 1 ng/dL at the time of
screening will be considered biomarker positive.

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.

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.

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. Subject must provide written Informed Consent prior to any study related procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria (none may be present)

Clinical exclusion criteria:

1. STEMI =24 hours from the onset of ischemic symptoms

2. Creatinine clearance =30 ml/min/1.73 m^2 (as calculated by MDRD formula for estimated
GFR) and not on dialysis. Note: chronic dialysis dependent patients are eligible for
enrolment regardless of creatinine clearance.

3. Hypotension, shock or need for mechanical support or intravenous vasopressors at the
time the patient would be undergoing the index procedure.

4. CHF (Killip class =2 or NYHA class =3)

5. LVEF =30% by the most recent imaging test within 3 months prior to procedure. If no
LVEF test result within 3 months is available, it must be assessed by
echocardiography, multiple gated acquisition (MUGA), magnetic resonance imaging (MRI),
ventriculography (LV gram) or other method.

6. Unstable ventricular arrhythmias

7. Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 months in
the patient presenting with an ACS, or at least 6 months in the patient presenting
with stable CAD, unless the patient is also taking chronic oral anticoagulation in
which case a shorter duration of DAPT may be prescribed per local standard of care.

8. Planned major cardiac or non-cardiac surgery within 24 months after the index
procedure.

Note: Major surgery is any invasive operative procedure in which an extensive
resection is performed, e.g. a body cavity is entered, organs are removed, or normal
anatomy is altered.

Note: Minor surgery is an operation on the superficial structures of the body or a
manipulative procedure that does not involve a serious risk. Planned minor surgery is
not excluded.

9. Prior PCI within the target vessel within 12 months

Note: Prior PCI within the target vessel within 12 months is allowed for in-stent
restenosis (target lesion is the prior PCI site) if no more than one layer of
previously implanted stent is present.

Note: In-stent restenosis involving two or more layers of stent implanted at any time
prior to index procedure (i.e. an earlier episode of in-stent restenosis previously
treated with a second stent) is excluded.

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.

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% for all treated non-target
lesions, with TIMI III flow in this vessel, without final dissection = NHLBI type B,
perforation anytime during the procedure, 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 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 a solid organ transplant which is functioning or is active on a
waiting list for any solid organ transplants with expected transplantation within 24
months.

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/mm^3 or >700,000 cells/mm^3.

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 currently participating in another investigational drug or device clinical
study that has not yet completed its primary endpoint.

23. Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years
following index procedure. Female subjects of child-bearing potential must have a
negative pregnancy test done within 7 days prior to the index procedure per site
standard test.

24. Presence of other anatomic or comorbid conditions, or other medical, social, or
psychological conditions that, in the investigator's opinion, could limit the
subject's ability to participate in the clinical investigation or to comply with
follow-up requirements, or impact the scientific soundness of the clinical
investigation results.

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

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 vessel has a lesion with DS = 50% that is not planned for treatment at the
time of index procedure.

6. The target lesion is in the left main coronary artery

7. 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.

8. The target lesion is an ostial RCA stenosis

9. The target lesion is a stent thrombosis

10. Planned use of any stent other than Xience in a target lesion

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2023
Sample size
Target
Accrual to date
Final
2690
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 0 0
Eastern Heart Clinic - Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 0 0
6150 - Murdoch
Recruitment postcode(s) [2] 0 0
6000 - Perth
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Florida
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Georgia
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Illinois
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Kansas
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Kentucky
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Massachusetts
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Minnesota
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Montana
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North Carolina
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Oregon
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South Carolina
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Tennessee
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Texas
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Utah
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Washington
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Belgium
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Eflndrs
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Belgium
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Flemish Brabant
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Quebec
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France
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Auvergn
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France
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France
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Rhone-Alpes
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Germany
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Bavaria
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Germany
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Hesse
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Germany
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Rhinela
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Germany
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Berlin
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Hong Kong
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Hk Sar
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India
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Tamil Nadu
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India
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Chandigarh
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India
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New Delhi
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Italy
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Latium
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Italy
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Lombard
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Japan
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Wakayama
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Zuid-Holland
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Canterbury
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New Zealand
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Wellington
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Portugal
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Lisbon
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Singapore
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Central
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Spain
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Madrid
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Sweden
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Vastra
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Bern
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Luzern
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Taiwan
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Ntaiwan
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United Kingdom
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West Midland
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United Kingdom
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Cambridge
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Abbott
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this prospective, single-blind clinical investigation is to demonstrate the
superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as
compared to an angiography-guided stent implantation strategy in achieving larger post-PCI
lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk
clinical characteristics and/or with high-risk angiographic lesions.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03507777
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregg W Stone, MD
Address 0 0
Icahn School of Medicine at Mount Sinai
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03507777