Coronary Artery DiseaseILUMIEN IIINCT02471586
OPTIMIZE PCI: Multicenter Randomized Trial of OCT Compared to IVUS and Angiography to Guide Coronary Stent Implantation
A study testing Coronary PCI guided by IVUS, Coronary PCI guided by OCT and Coronary PCI guided by Angiography in people with Coronary Artery Disease, run by Abbott Medical Devices at 29 sites in 8 countries.
Trial summary
The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary PCI guided by IVUS, Coronary PCI guided by OCT and Coronary PCI guided by Angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 29 sitesin 8 countries
- Study dates
- May 2015to 25 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
29 sites in 8 countries.
29 sites in 8 countries
United States17 sites
Emory University Hospital
Atlanta, Georgia, 30322
Austin Heart
Austin, Texas, 78705
St. Charles Medical Center
Bend, Oregon, 97701
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35249
Heart Institute of Colorado
Broomfield, Colorado, 80021
Eastern Cardiology
Greenville, North Carolina, 27834
Memorial Hermann Hospital
Houston, Texas, 77030
Kansas University Medical Center
Kansas City, Kansas, 66160
New York Presbyterian Hospital/Columbia University
New York, New York, 10032
Lenox Hill Hospital
New York, New York, 10075
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Orlando Health
Orlando, Florida, 32806
St. Francis Hospital
Roslyn, New York, 11576
The University of Texas Health Science at San Antonio
San Antonio, Texas, 78229
University of California at San Diego (UCSD) Medical Center
San Diego, California, 92037
Scottsdale Healthcare Shea
Scottsdale, Arizona, 85260
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655
Japan5 sites
Kobe University Hospital
Chuo-ku, Hyōgo, 650-0017
Nara Medical University Hospital
Kashihara-shi, Nara, 634-8521
Osaka Saiseikai Nakatsu Hospital
Osaka, Osaka, 530-0012
Yamaguchi University Hospital
Ube-shi, Yamaguchi, 755-0046
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
Italy2 sites
Ospedale Papa Giovanni XXIII
Bergamo, Lombardy, 24127
Centro Cardiologico Monzino
Milan, Lombardy, 20138
Belgium1 site
Onze-Lieve-Vrouwziekenhuis Campus Aalst
Aalst, East Flanders, 9300
Netherlands1 site
Erasmus MC - Thoraxcenter
Rotterdam, South Holland, 3015 CE
About this study
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)
The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation
Read the detailed description
This is a prospective, post-market, international, multi-center, randomized clinical investigation in which the participants will be randomized in 1:1:1 ratio to undergo PCI with either OCT, IVUS, or Angiography guidance. The clinical investigation will be conducted at approximately 35 sites in the United States and outside the United States; approximately 25% of subjects will be enrolled in the United States.
Patients in the IVUS and OCT groups patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography group and IVUS groups will undergo a blinded post-PCI OCT run to allow comparison of OCT derived minimum stent area (MSA) in both groups.
After hospital discharge, all patients will have clinical follow-up at 30 days, and 1 year.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary PCI guided by IVUS, Coronary PCI guided by OCT, Coronary PCI guided by Angiography
- Keywords
- Percutaneous Coronary Intervention, Intravascular Ultrasound, Optical Coherence Tomography, SJM-CIP-10034
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary PCI guided by IVUSProcedure or surgery
Also called Intravascular Ultrasound
Imaging type
Coronary PCI guided by OCTProcedure or surgery
Also called Optical Coherence Tomography
Imaging type
Coronary PCI guided by AngiographyProcedure or surgery
Imaging type
| Study group | Role | What they receive |
|---|---|---|
| Coronary PCI guided by IVUS | Active comparator | 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. Receives: Procedure: Coronary PCI guided by IVUS |
| Coronary PCI guided by OCT | Active comparator | 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. Receives: Procedure: Coronary PCI guided by OCT |
| Coronary PCI guided by Angiography | Active comparator | 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. Receives: Procedure: Coronary PCI guided by Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA)
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.
Measured: Post-procedure within 1 hour
Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event)
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).
Measured: During procedure, an average of 1 hour
Secondary outcomes (32)
Number of Participants With Acute Procedural Success
Acute procedural success are classified as:
- 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.
- 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.
- 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.
- 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.
Measured: During procedure, an average of 1 hour
Rate of Post-PCI Stent Expansion (%)
Post-PCI stent expansion is defined as the minimum stent area divided by the average of proximal and distal reference lumen areas x 100.
Measured: Up to 1 hour post-procedure
Rate of Mean Stent Expansion (%)
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.
Measured: During procedure, an average of 1 hour
Number of Participants With Plaque Protrusion and Thrombus
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%
Measured: During procedure, an average of 1 hour
Number of Participants With Untreated Reference Segment Disease
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.
Measured: During procedure, an average of 1 hour
Number of Participants With Edge Dissections
Edge Dissections are classified as
- Major (%): ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length
- Minor (%): any visible edge dissection <60 degrees of the circumference of the vessel and < 3 mm in length
- All (Major and Minor)
Edge dissections will be further classified as:
- 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
Measured: During procedure, an average of 1 hour
Number of Participants With Stent Malapposition
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
Measured: During procedure, an average of 1 hour
Number of Participants With Border Detection (OCT Arm Only)
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:
- Good: ≥75% (270°) of visible circumference
- Moderate: ≥50% (180°) - <75% (270°) of visible circumference
- Poor: <50% (180°) of visible circumference
Measured: Pre-PCI OCT Run procedure
Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run
Clinical decision making will be assessed on the basis of the post-stent imaging run
Measured: During procedure, an average of 1 hour
Median Intra-stent Lumen Area (Intra-stent Flow Area)
Intra-stent Lumen Area (Intra-stent Flow Area) is defined as stent area minus any protrusion
Measured: Up to 1 hour post-procedure
Median Effective Lumen Area (Total Flow Area)
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).
Measured: Up to 1 hour post-procedure
IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only)
Dissection (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts
Measured: During procedure, an average of 1 hour
IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only)
Malapposition (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts
Measured: During procedure, an average of 1 hour
IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only)
Protrusion (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts
Measured: During procedure, an average of 1 hour
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter
Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter
Measured: Baseline
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter
Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter
Measured: Final Post-PCI, up to 1 hour after PCI procedure
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis
Angiographic Endpoints (QCA) will be assessed as diameter stenosis
Measured: Baseline
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis
Angiographic Endpoints (QCA) will be assessed as diameter stenosis
Measured: Final Post-PCI, up to 1 hour after PCI procedure
Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention
Angiographic Endpoints (QCA) will be assessed as Acute lumen gain post-intervention
Measured: Final Post-PCI, up to 1 hour after PCI procedure
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio
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.
Measured: Baseline
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio
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.
Measured: Final Post-PCI, up to 1 hour after PCI procedure
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B
Angiographic Endpoints (QCA) will be assessed as Angiographic dissection ≥ NHLBI type B
Measured: Final Post-PCI, up to 1 hour after PCI procedure
Procedural Endpoints (Site Reported): Median Total Stent Length
Median Total Stent Length will be measured in millimeters.
Measured: During procedure, an average of 1 hour
Procedural Endpoints (Site Reported): Median Stents Per Lesion
Median Stents per lesion will be measured in counts
Measured: During procedure, an average of 1 hour
Procedural Endpoints (Site Reported) - Median Maximal Stent Size
Median Maximal stent size will be measured in millimeters.
Measured: During procedure, an average of 1 hour
Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations
Post dilatation inflations will be assessed in terms of use of balloon inflations
Measured: During procedure, an average of 1 hour
Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.)
Median Maximum inflation pressure will be measured in atm.
Measured: During procedure, an average of 1 hour
Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions
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
Measured: During procedure, an average of 1 hour
Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate
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.
Measured: During procedure, an average of 1 hour
Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate
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)
Measured: During procedure, an average of 1 hour
Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF)
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.
Measured: 1 year
Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction
Number of Participants With Periprocedural Myocardial Infarction will be assessed at 1 year
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion5 Apr 2016
- Study completion25 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardiovascular Research Foundation, New York
- Responsible party
- Sponsor
- Investigators
- Ziad Ali, MD, Principal investigator, Columbia Presbyterian Medical Center (NY)Gregg W Stone, MD, Study chair, Columbia Presbyterian Medical Center (NY)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471586
- Sponsor's protocol ID
- SJM-CIP-10034
- Acronym
- ILUMIEN III
- Status last verified
- Mar 2021
- First submitted
- 17 Nov 2014
- Last updated
- 1 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Ali ZA, Karimi Galougahi K, Maehara A, Shlofmitz RA, Fabbiocchi F, Guagliumi G, Alfonso F, Akasaka T, Matsumura M, Mintz GS, Ben-Yehuda O, Zhang Z, Rapoza RR, West NEJ, Stone GW. Outcomes of optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation: one-year results from the ILUMIEN III: OPTIMIZE PCI trial. EuroIntervention. 2021 Jan 20;16(13):1085-1091. doi: 10.4244/EIJ-D-20-00498.
PubMed 32540793Ali ZA, Maehara A, Genereux P, Shlofmitz RA, Fabbiocchi F, Nazif TM, Guagliumi G, Meraj PM, Alfonso F, Samady H, Akasaka T, Carlson EB, Leesar MA, Matsumura M, Ozan MO, Mintz GS, Ben-Yehuda O, Stone GW; ILUMIEN III: OPTIMIZE PCI Investigators. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet. 2016 Nov 26;388(10060):2618-2628. doi: 10.1016/S0140-6736(16)31922-5. Epub 2016 Oct 30.
PubMed 27806900
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02471586
- Acronym / sponsor ID
- ILUMIEN III / SJM-CIP-10034
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention, Intravascular Ultrasound, Optical Coherence Tomography, SJM-CIP-10034
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Cardiovascular Research Foundation, New York
- Study start
- May 2015 (actual)
- Primary completion
- 5 Apr 2016 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Posted 1 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation
Detailed description
This is a prospective, post-market, international, multi-center, randomized clinical investigation in which the participants will be randomized in 1:1:1 ratio to undergo PCI with either OCT, IVUS, or Angiography guidance. The clinical investigation will be conducted at approximately 35 sites in the United States and outside the United States; approximately 25% of subjects will be enrolled in the United States.
Patients in the IVUS and OCT groups patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography group and IVUS groups will undergo a blinded post-PCI OCT run to allow comparison of OCT derived minimum stent area (MSA) in both groups.
After hospital discharge, all patients will have clinical follow-up at 30 days, and 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coronary PCI guided by IVUS | Active comparator | Procedure: Coronary PCI guided by IVUSIntervention = 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. |
| Coronary PCI guided by OCT | Active comparator | Procedure: Coronary PCI guided by OCTIntervention = 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. |
| Coronary PCI guided by Angiography | Active comparator | Procedure: Coronary PCI guided by AngiographyIntervention = 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary PCI guided by IVUSAlso: Intravascular UltrasoundImaging type | Procedure or surgery | Coronary PCI guided by IVUS |
| Coronary PCI guided by OCTAlso: Optical Coherence TomographyImaging type | Procedure or surgery | Coronary PCI guided by OCT |
| Coronary PCI guided by AngiographyImaging type | Procedure or surgery | Coronary PCI guided by Angiography |
Primary outcome
Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA)
Time frame: Post-procedure within 1 hour
Post-PCI MSA will be assessed by OCT in each randomized arm, measured at the independent OCT core laboratory blinded to imaging modality assignment. Hierarchal manner testing will be as follows: 1. Non-inferiority: OCT vs. IVUS guided stenting Non-inferiority of OCT guided stenting to IVUS guided stenting will be analyzed for the mean difference between the post PCI MSA for the OCT and IVUS arms with non-inferiority margin of 1.0 mm^2. 2. Superiority: OCT vs. Angiography guided stenting If the OCT guided stenting arm was found to be non-inferior to the IVUS guided stenting arm, the superiority of OCT to angiography will be tested for the mean difference between the post PCI MSA for the OCT and angiography arms. 3. Superiority: OCT vs. IVUS guided stenting If the OCT guided stenting arm was found to be superior to the IVUS guided stenting arm, then the superiority of OCT to IVUS will be tested for the mean difference between the post PCI MSA for the OCT and IVUS arms.
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).
32 secondary outcomes
Number of Participants With Acute Procedural Success
Time frame: During procedure, an average of 1 hour
Rate of Post-PCI Stent Expansion (%)
Time frame: Up to 1 hour post-procedure
Rate of Mean Stent Expansion (%)
Time frame: During procedure, an average of 1 hour
Number of Participants With Plaque Protrusion and Thrombus
Time frame: During procedure, an average of 1 hour
Number of Participants With Untreated Reference Segment Disease
Time frame: During procedure, an average of 1 hour
Number of Participants With Edge Dissections
Time frame: During procedure, an average of 1 hour
Number of Participants With Stent Malapposition
Time frame: During procedure, an average of 1 hour
Number of Participants With Border Detection (OCT Arm Only)
Time frame: Pre-PCI OCT Run procedure
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
Median Intra-stent Lumen Area (Intra-stent Flow Area)
Time frame: Up to 1 hour post-procedure
Median Effective Lumen Area (Total Flow Area)
Time frame: Up to 1 hour post-procedure
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
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
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
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter
Time frame: Baseline
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter
Time frame: Final Post-PCI, up to 1 hour after PCI procedure
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis
Time frame: Baseline
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis
Time frame: Final Post-PCI, up to 1 hour after PCI procedure
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
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio
Time frame: Baseline
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
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
Procedural Endpoints (Site Reported): Median Total Stent Length
Time frame: During procedure, an average of 1 hour
Procedural Endpoints (Site Reported): Median Stents Per Lesion
Time frame: During procedure, an average of 1 hour
Procedural Endpoints (Site Reported) - Median Maximal Stent Size
Time frame: During procedure, an average of 1 hour
Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations
Time frame: During procedure, an average of 1 hour
Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.)
Time frame: During procedure, an average of 1 hour
Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions
Time frame: During procedure, an average of 1 hour
Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate
Time frame: During procedure, an average of 1 hour
Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate
Time frame: During procedure, an average of 1 hour
Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF)
Time frame: 1 year
Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction
Time frame: 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32540793Ali ZA, Karimi Galougahi K, Maehara A, Shlofmitz RA, Fabbiocchi F, Guagliumi G, Alfonso F, Akasaka T, Matsumura M, Mintz GS, Ben-Yehuda O, Zhang Z, Rapoza RR, West NEJ, Stone GW. Outcomes of optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation: one-year results from the ILUMIEN III: OPTIMIZE PCI trial. EuroIntervention. 2021 Jan 20;16(13):1085-1091. doi: 10.4244/EIJ-D-20-00498.
- Derived from this study: PubMed 27806900Ali ZA, Maehara A, Genereux P, Shlofmitz RA, Fabbiocchi F, Nazif TM, Guagliumi G, Meraj PM, Alfonso F, Samady H, Akasaka T, Carlson EB, Leesar MA, Matsumura M, Ozan MO, Mintz GS, Ben-Yehuda O, Stone GW; ILUMIEN III: OPTIMIZE PCI Investigators. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet. 2016 Nov 26;388(10060):2618-2628. doi: 10.1016/S0140-6736(16)31922-5. Epub 2016 Oct 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziad Ali, MD principal investigator
Columbia Presbyterian Medical Center (NY)
Gregg W Stone, MD study chair
Columbia Presbyterian Medical Center (NY)
29 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary PCI guided by IVUS, Coronary PCI guided by OCT and Coronary PCI guided by Angiography in people with Coronary Artery Disease, run by Abbott Medical Devices at 29 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Japan, Italy, Belgium, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA) (time frame: Post-procedure within 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02471586, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.