OPTIMIZE PCI: Multicenter Randomized Trial of OCT Compared to IVUS and Angiography to Guide Coronary Stent Implantation

Coronary Artery Disease Clinical Trial

— ILUMIEN III  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471586
• Other study ID #: SJM-CIP-10034
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: April 25, 2017

Study information

• Verified date: March 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: April 25, 2017
• Est. primary completion date: April 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Coronary PCI guided by IVUS
Imaging type
• Coronary PCI guided by OCT
Imaging type
• Coronary PCI guided by Angiography
Imaging type

Locations

Country	Name	City	State
Belgium	Onze-Lieve-Vrouwziekenhuis Campus Aalst	Aalst	East Flanders
Germany	Klinikum der Justus-Liebig-Universität	Giessen	Hesse
Italy	Ospedale Papa Giovanni XXIII	Bergamo	Lombardy
Italy	Centro Cardiologico Monzino	Milan	Lombardy
Japan	Kobe University Hospital	Chuo-ku	Hyogo
Japan	Nara Medical University Hospital	Kashihara-shi	Nara
Japan	Osaka Saiseikai Nakatsu Hospital	Osaka-shi	Osaka
Japan	Yamaguchi University Hospital	Ube-shi	Yamaguchi
Japan	Wakayama Medical University Hospital	Wakayama City	Wakayama
Netherlands	Erasmus MC - Thoraxcenter	Rotterdam	Zuid-Holland
Spain	Hospital Universitario de la Princesa	Madrid
United Kingdom	Kings College Hospital	Brixton	London
United States	Emory University Hospital	Atlanta	Georgia
United States	Austin Heart	Austin	Texas
United States	St. Charles Medical Center	Bend	Oregon
United States	University Hospital - Univ. of Alabama at Birmingham (UAB)	Birmingham	Alabama
United States	Heart Institute of Colorado	Broomfield	Colorado
United States	Eastern Cardiology	Greenville	North Carolina
United States	Memorial Hermann Hospital	Houston	Texas
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Lenox Hill Hospital	New York	New York
United States	New York Presbyterian Hospital/Columbia University	New York	New York
United States	INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma
United States	Orlando Health	Orlando	Florida
United States	St. Francis Hospital	Roslyn	New York
United States	The University of Texas Health Science at San Antonio	San Antonio	Texas
United States	University of California at San Diego (UCSD) Medical Center	San Diego	California
United States	Scottsdale Healthcare Shea	Scottsdale	Arizona
United States	University of Massachusetts Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Cardiovascular Research Foundation, New York

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Italy,  Japan,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post-procedure within 1 hour
Primary	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).	During procedure, an average of 1 hour
Secondary	Number of Participants With Acute Procedural Success	Acute procedural success are classified as: A) 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.; B) 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.; C) 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.; D) 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.	During procedure, an average of 1 hour
Secondary	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.	Up to 1 hour post-procedure
Secondary	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.	During procedure, an average of 1 hour
Secondary	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%	During procedure, an average of 1 hour
Secondary	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.	During procedure, an average of 1 hour
Secondary	Number of Participants With Edge Dissections	Edge Dissections are classified as; A) Major (%): =60 degrees of the circumference of the vessel at site of dissection and/or =3 mm in length; B) Minor (%): any visible edge dissection <60 degrees of the circumference of the vessel and < 3 mm in length; C) All (Major and Minor); Edge dissections will be further classified as: I. 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	During procedure, an average of 1 hour
Secondary	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	During procedure, an average of 1 hour
Secondary	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: A) Good: =75% (270°) of visible circumference; B) Moderate: =50% (180°) - <75% (270°) of visible circumference; C) Poor: <50% (180°) of visible circumference	Pre-PCI OCT Run procedure
Secondary	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	During procedure, an average of 1 hour
Secondary	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	Up to 1 hour post-procedure
Secondary	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).	Up to 1 hour post-procedure
Secondary	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	During procedure, an average of 1 hour
Secondary	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	During procedure, an average of 1 hour
Secondary	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	During procedure, an average of 1 hour
Secondary	Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter	Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter	Baseline
Secondary	Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter	Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter	Final Post-PCI, up to 1 hour after PCI procedure
Secondary	Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis	Angiographic Endpoints (QCA) will be assessed as diameter stenosis	Baseline
Secondary	Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis	Angiographic Endpoints (QCA) will be assessed as diameter stenosis	Final Post-PCI, up to 1 hour after PCI procedure
Secondary	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	Final Post-PCI, up to 1 hour after PCI procedure
Secondary	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.	Baseline
Secondary	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.	Final Post-PCI, up to 1 hour after PCI procedure
Secondary	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	Final Post-PCI, up to 1 hour after PCI procedure
Secondary	Procedural Endpoints (Site Reported): Median Total Stent Length	Median Total Stent Length will be measured in millimeters.	During procedure, an average of 1 hour
Secondary	Procedural Endpoints (Site Reported): Median Stents Per Lesion	Median Stents per lesion will be measured in counts	During procedure, an average of 1 hour
Secondary	Procedural Endpoints (Site Reported) - Median Maximal Stent Size	Median Maximal stent size will be measured in millimeters.	During procedure, an average of 1 hour
Secondary	Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations	Post dilatation inflations will be assessed in terms of use of balloon inflations	During procedure, an average of 1 hour
Secondary	Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.)	Median Maximum inflation pressure will be measured in atm.	During procedure, an average of 1 hour
Secondary	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	During procedure, an average of 1 hour
Secondary	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.	During procedure, an average of 1 hour
Secondary	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)	During procedure, an average of 1 hour
Secondary	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.	1 year
Secondary	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	1 Year