Clinical trial NCT02471586: OPTIMIZE PCI: Multicenter Randomized Trial of OCT Compared to IVUS and Angiography to Guide Coronary Stent Implantation
Official title: ILUMIEN III: OPTIMIZE PCI: OPtical Coherence Tomography (OCT) Compared to Intravascular Ultrasound (IVUS) and Angiography to Guide Coronary Stent Implantation: a Multicenter RandomIZEd Trial in Percutaneous Coronary Intervention (PCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention
Intravascular Ultrasound
Optical Coherence Tomography
SJM-CIP-10034
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Cardiovascular Research Foundation, New York
First posted: 2015-06-15
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: General Inclusion Criteria:

1. Age ≥ 18 years.
2. Patient with an indication for PCI including:

   * Angina (stable or unstable),
   * Silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present),
   * NSTEMI, or
   * Recent STEMI (\>24 hours from initial presentation and stable).
3. Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES)
4. Signed written informed consent

Angiographic inclusion criteria:

1. The target lesion must be located in a native coronary artery with visually estimated reference vessel diameter of ≥2.25 mm to ≤3.50 mm.
2. Lesion length \<40mm

General Exclusion Criteria:

1. Estimated creatinine clearance \<30 ml/min using Cockcroft-Gault equation, unless the patient is on dialysis
2. STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital.
3. PCI within 24 hours preceding the study procedure.
4. PCI of a lesion within the target vessel within 12 months prior to the study procedure
5. Planned use of bare metal stent (BMS)
6. Planned use of bioresorbable vascular scaffold (BVS)
7. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure \<90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP, at time of procedure.
8. Mobitz II second degree or complete heart block
9. Malignant ventricular arrhythmias requiring treatment
10. Pulmonary edema defined as patient with shortness of breath, evidence of volume overload on physical exam, and crepitations on physical exam (\>1/3 of lungs) or radiographic interstitial or alveolar pulmonary edema
11. Subject is intubated.
12. Known LVEF \<30%.
13. Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis)
14. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA.
15. Presence of one or more co-morbidities which reduces life expectancy to less than 12 months or may interfere with protocol study processes.
16. Known allergy to protocol-required concomitant medications including aspirin; clopidogrel, prasugrel, and ticagrelor; heparin and bivalirudin; or iodinated contrast that cannot be adequately pre-medicated.
17. Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint.
18. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before treatment).

Angiographic Exclusion Criteria:

1. The presence of any non-study lesion in the target vessel with angiographic diameter stenosis \>50%, or any additional target vessel stenosis which requires PCI either during or within 12 months after the study procedure
2. Left main diameter stenosis ≥30% or left main PCI planned.
3. Study target lesion in a bypass graft
4. Ostial RCA study target lesion
5. Chronic total occlusion (TIMI flow 0/1) study target lesion
6. Bifurcation study lesion with a planned dual stent strategy
7. In-stent restenosis study target lesion
8. Any study lesion characteristic resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre and post PCI (e.g. moderate or severe vessel calcification or tortuosity)

Primary outcomes:
measure: Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA)
timeFrame: Post-procedure within 1 hour
measure: Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event)
timeFrame: During procedure, an average of 1 hour
Secondary outcomes:
measure: Number of Participants With Acute Procedural Success
timeFrame: During procedure, an average of 1 hour
measure: Rate of Post-PCI Stent Expansion (%)
timeFrame: Up to 1 hour post-procedure
measure: Rate of Mean Stent Expansion (%)
timeFrame: During procedure, an average of 1 hour
measure: Number of Participants With Plaque Protrusion and Thrombus
timeFrame: During procedure, an average of 1 hour
measure: Number of Participants With Untreated Reference Segment Disease
timeFrame: During procedure, an average of 1 hour
measure: Number of Participants With Edge Dissections
timeFrame: During procedure, an average of 1 hour
measure: Number of Participants With Stent Malapposition
timeFrame: During procedure, an average of 1 hour
measure: Number of Participants With Border Detection (OCT Arm Only)
timeFrame: Pre-PCI OCT Run procedure
measure: Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run
timeFrame: During procedure, an average of 1 hour
measure: Median Intra-stent Lumen Area (Intra-stent Flow Area)
timeFrame: Up to 1 hour post-procedure
measure: Median Effective Lumen Area (Total Flow Area)
timeFrame: Up to 1 hour post-procedure
measure: IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only)
timeFrame: During procedure, an average of 1 hour
measure: IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only)
timeFrame: During procedure, an average of 1 hour
measure: IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only)
timeFrame: During procedure, an average of 1 hour
measure: Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter
timeFrame: Baseline
measure: Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter
timeFrame: Final Post-PCI, up to 1 hour after PCI procedure
measure: Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis
timeFrame: Baseline
measure: Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis
timeFrame: Final Post-PCI, up to 1 hour after PCI procedure
measure: Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention
timeFrame: Final Post-PCI, up to 1 hour after PCI procedure
measure: Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio
timeFrame: Baseline
measure: Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio
timeFrame: Final Post-PCI, up to 1 hour after PCI procedure
measure: Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B
timeFrame: Final Post-PCI, up to 1 hour after PCI procedure
measure: Procedural Endpoints (Site Reported): Median Total Stent Length
timeFrame: During procedure, an average of 1 hour
measure: Procedural Endpoints (Site Reported): Median Stents Per Lesion
timeFrame: During procedure, an average of 1 hour
measure: Procedural Endpoints (Site Reported) - Median Maximal Stent Size
timeFrame: During procedure, an average of 1 hour
measure: Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations
timeFrame: During procedure, an average of 1 hour
measure: Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.)
timeFrame: During procedure, an average of 1 hour
measure: Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions
timeFrame: During procedure, an average of 1 hour
measure: Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate
timeFrame: During procedure, an average of 1 hour
measure: Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate
timeFrame: During procedure, an average of 1 hour
measure: Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF)
timeFrame: 1 year
measure: Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction
timeFrame: 1 Year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Hospital - Univ. of Alabama at Birmingham (UAB)
state: Alabama
city: Scottsdale
country: United States
facility: Scottsdale Healthcare Shea
state: Arizona
city: San Diego
country: United States
facility: University of California at San Diego (UCSD) Medical Center
state: California
city: Broomfield
country: United States
facility: Heart Institute of Colorado
state: Colorado
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: New York
country: United States
facility: New York Presbyterian Hospital/Columbia University
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Greenville
country: United States
facility: Eastern Cardiology
state: North Carolina
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center
state: Oklahoma
city: Bend
country: United States
facility: St. Charles Medical Center
state: Oregon
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science at San Antonio
state: Texas
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis Campus Aalst
state: East Flanders
city: Giessen
country: Germany
facility: Klinikum der Justus-Liebig-Universität
state: Hesse
city: Bergamo
country: Italy
facility: Ospedale Papa Giovanni XXIII
state: Lombardy
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
state: Lombardy
city: Chuo-ku
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Kashihara-shi
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Osaka-shi
country: Japan
facility: Osaka Saiseikai Nakatsu Hospital
state: Osaka
city: Wakayama City
country: Japan
facility: Wakayama Medical University Hospital
state: Wakayama
city: Ube-shi
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Thoraxcenter
state: Zuid-Holland
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Brixton
country: United Kingdom
facility: Kings College Hospital
state: London
Study officials:
affiliation: Columbia Presbyterian Medical Center (NY)
name: Ziad Ali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia Presbyterian Medical Center (NY)
name: Gregg W Stone, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Ali 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.