Observational Study of OCT in a Patients Undergoing FFR (ILUMIEN I)

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ClinicalTrials.gov Identifier: NCT01663896

Recruitment Status : Completed

First Posted : August 13, 2012

Results First Posted : July 2, 2020

Last Update Posted : July 2, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Abbott Medical Devices

Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Condition	Coronary Artery Disease
Intervention	Device: OCT stent guidance
Enrollment	418

Participant Flow

Recruitment Details	Initially a total of 1069 subjects gave consent from 36 investigational sites, of which 418 qualified subjects completed enrollment in February 2014 at 35 investigational sites. First subject was enrolled on Dec 11, 2012 and the last subject completed the 12 month follow-up on Mar 12, 2015.
Pre-assignment Details	Of the 1069 subjects, 616 were failed to screen and 35 were not qualified for inclusion. Thus 418 subjects underwent pre-intervention fractional flow reserve (FFR) and optical coherence tomography (OCT), percutaneous coronary intervention (PCI), and post intervention FFR and OCT. The subjects were followed up through 12 month post stent implant.


Arm/Group Title	Optical Coherence Tomography (OCT)
Arm/Group Description	Participants undergoing PCI with in...
Arm/Group Description	Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
Period Title: Overall Study
Started	418
Completed	375
Not Completed	43
Reason Not Completed
Various reasons	43

Baseline Characteristics

Arm/Group Title		Optical Coherence Tomography (OCT)
Arm/Group Description		Participants undergoing PCI with in...
Arm/Group Description		Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
Overall Number of Baseline Participants		418
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	418 participants
		64.7 (10.2)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	418 participants
	Female	104 24.9%
	Male	314 75.1%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	418 participants
United States		153 36.6%
Czechia		14 3.3%
Japan		97 23.2%
United Kingdom		7 1.7%
Spain		11 2.6%
Canada		4 1.0%
Austria		5 1.2%
Netherlands		4 1.0%
Belgium		44 10.5%
China		25 6.0%
Italy		32 7.7%
Australia		11 2.6%
France		5 1.2%
Germany		6 1.4%

Outcome Measures

1.Primary Outcome


Title	Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Description	Incidence of OCT peri-procedural guidance parameter(s) for stenting an...
Description	Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital.
Time Frame	In-hospital until discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Optical Coherence Tomography (OCT)
Arm/Group Description:	A subject who provides a signed Inf...
Arm/Group Description:	A subject who provides a signed Informed Consent Form, meets eligibility criteria, undergoes angiography and pre-intervention FFR, OCT, PCI, and post intervention FFR and OCT.
Overall Number of Participants Analyzed	418
Measure Type: Number Unit of Measure: Percentage of per-subject incidence
Device-oriented MACE (Cardiac death)	0
Device-oriented MACE(MI-AEC definition)	6.7
Device-oriented MACE(MI-3rd Universal definition)	6.2
Device-oriented MACE(TLR)	0.2
Patient-oriented MACE(All-cause mortality)	0.2
Patient-oriented MACE(MI-ARC Definition)	6.7
Patient-oriented MACE(MI-3rd Universal definition)	6.2
Patient-oriented MACE(Any Revascularization)	0.2
Stent Thrombosis(Definite)	0
Stent Thrombosis(Probable)	0
Stent Thrombosis(Possible)	0
Stent Thrombosis(Early)	0
Stent Thrombosis(Late)	0
Stent Thrombosis(Very Late)	0

2.Primary Outcome


Title	Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Description	Incidence of OCT peri-procedural guidance parameter(s) for stenting an...
Description	Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 30 days
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Optical Coherence Tomography (OCT)
Arm/Group Description:	A subject who provides a signed Inf...
Arm/Group Description:	A subject who provides a signed Informed Consent Form, meets eligibility criteria, undergoes angiography and pre-intervention FFR, OCT, PCI, and post intervention FFR and OCT.
Overall Number of Participants Analyzed	416
Measure Type: Number Unit of Measure: Percentage of per-subject incidence
Device-oriented MACE (Cardiac death)	0
Device-oriented MACE(MI-AEC definition)	7.2
Device-oriented MACE(MI-3rd Universal definition)	6.7
Device-oriented MACE(TLR)	0.7
Patient-oriented MACE(All-cause mortality)	0.2
Patient-oriented MACE(MI-ARC Definition)	7.9
Patient-oriented MACE(MI-3rd Universal definition)	7.5
Patient-oriented MACE(Any Revascularization)	1.7
Stent Thrombosis(Definite)	0
Stent Thrombosis(Probable)	0
Stent Thrombosis(Possible)	0
Stent Thrombosis(Early)	0.2
Stent Thrombosis(Late)	0
Stent Thrombosis(Very Late)	0

3.Primary Outcome


Title	Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Description	Incidence of OCT peri-procedural guidance parameter(s) for stenting an...
Description	Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Optical Coherence Tomography (OCT)
Arm/Group Description:	A subject who provides a signed Inf...
Arm/Group Description:	A subject who provides a signed Informed Consent Form, meets eligibility criteria, undergoes angiography and pre-intervention FFR, OCT, PCI, and post intervention FFR and OCT.
Overall Number of Participants Analyzed	399
Measure Type: Number Unit of Measure: Percentage of per-subject incidence
Device-oriented MACE (Cardiac death)	0
Device-oriented MACE(MI-AEC definition)	8.3
Device-oriented MACE(MI-3rd Universal definition)	7.8
Device-oriented MACE(TLR)	2.5
Patient-oriented MACE(All-cause mortality)	1.8
Patient-oriented MACE(MI-ARC Definition)	9.3
Patient-oriented MACE(MI-3rd Universal definition)	8.8
Patient-oriented MACE(Any Revascularization)	5.5
Stent Thrombosis(Definite)	0.3
Stent Thrombosis(Probable)	0
Stent Thrombosis(Possible)	0.5
Stent Thrombosis(Early)	0.3
Stent Thrombosis(Late)	0.5
Stent Thrombosis(Very Late)	0

4.Secondary Outcome


Title	Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT
Description	Assessment of OCT on Physician Decision Making includes: ...
Description	Assessment of OCT on Physician Decision Making includes: Frequency of changes in treatment strategy based on OCT parameter real time assessment vs. angiographic assessment OCT parameters as assessed by Core Lab
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Optical Coherence Tomography (OCT)
Arm/Group Description:	Participants undergoing PCI with in...
Arm/Group Description:	Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
Overall Number of Participants Analyzed	418
Measure Type: Number Unit of Measure: Percentage of participants
Procedure Planning(Pre-PCI OCT)	57
Procedure Planning(Post-PCI OCT)	27
Physician decision-making (Pre-PCI OCT)	65
Physician decision-making (Post-PCI OCT)	65

Adverse Events

Time Frame	1-Year
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Optical Coherence Tomography (OCT)
Arm/Group Description	Participants undergoing PCI with in...
Arm/Group Description	Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
All-Cause Mortality
	Optical Coherence Tomography (OCT)
	Affected / at Risk (%)
Total	8/418 (1.91%)
Serious Adverse Events Serious Adverse Events
	Optical Coherence Tomography (OCT)
	Affected / at Risk (%)
Total	112/418 (26.79%)
Blood and lymphatic system disorders
Anemias ^† 1	1/418 (0.24%)
Bleeding ^† 1	2/418 (0.48%)
Cardiac disorders
Angina Pectoris ^† 1	1/418 (0.24%)
Atrial Fibrillation ^† 1	3/418 (0.72%)
Atrial Flutter ^† 1	1/418 (0.24%)
Atrioventricular (AV) Dissociation ^† 1	1/418 (0.24%)
Cardiac Arrest ^† 1	1/418 (0.24%)
Cardiomyopathy ^† 1	1/418 (0.24%)
Cardiovascular Deconditioning ^† 1	1/418 (0.24%)
Coronary Artery Disease ^† 1	2/418 (0.48%)
Heart Failure ^† 1	2/418 (0.48%)
Left Bundle Branch Block/Complete Left Bundle Branch Block ^† 1	1/418 (0.24%)
Myocardial Infarction ^† 1	8/418 (1.91%)
Pericardial Tamponade ^† 1	1/418 (0.24%)
Third Degree Heart Block (Complete Heart Block) ^† 1	1/418 (0.24%)
Unstable Angina ^† 1	3/418 (0.72%)
Ventricular Fibrillation ^† 1	2/418 (0.48%)
Endocrine disorders
Diabetic Ketoacidosis ^† 1	1/418 (0.24%)
Eye disorders
Visual Disturbance ^† 1	1/418 (0.24%)
Gastrointestinal disorders
Abdominal Pain ^† 1	1/418 (0.24%)
Acute Erosive Gastritis ^† 1	1/418 (0.24%)
Diarrhea ^† 1	1/418 (0.24%)
Emesis/Vomiting ^† 1	1/418 (0.24%)
Gastrointestinal Bleeding ^† 1	6/418 (1.44%)
General disorders
Ascites ^† 1	1/418 (0.24%)
Chest Pain ^† 1	24/418 (5.74%)
Discomfort ^† 1	1/418 (0.24%)
Gingival Bleeding ^† 1	1/418 (0.24%)
Hematochezia ^† 1	1/418 (0.24%)
Melena ^† 1	2/418 (0.48%)
Non-Cardiac Chest Pain ^† 1	1/418 (0.24%)
Other ^† 1	14/418 (3.35%)
Hepatobiliary disorders
Cholelithiasis ^† 1	1/418 (0.24%)
Infections and infestations
Influenza ^† 1	1/418 (0.24%)
Pneumonia ^† 1	2/418 (0.48%)
Pneumonia in the Compromised Host ^† 1	1/418 (0.24%)
Injury, poisoning and procedural complications
Ankle Fracture ^† 1	1/418 (0.24%)
Side Branch Compromise ^† 1	1/418 (0.24%)
Investigations
Abnormal Lab Value ^† 1	2/418 (0.48%)
EKG Abnormalities ^† 1	1/418 (0.24%)
Echo Finding ^† 1	1/418 (0.24%)
Hyperkalemia ^† 1	1/418 (0.24%)
Musculoskeletal and connective tissue disorders
Gout ^† 1	1/418 (0.24%)
Knee Pain ^† 1	1/418 (0.24%)
Musculoskeletal Pain ^† 1	1/418 (0.24%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer ^† 1	2/418 (0.48%)
Colon Cancer ^† 1	2/418 (0.48%)
Colon Polyps ^† 1	1/418 (0.24%)
Lung Cancer ^† 1	1/418 (0.24%)
Nervous system disorders
Intracerebral Haemorrhage ^† 1	1/418 (0.24%)
Ischemic Stroke ^† 1	1/418 (0.24%)
Non-Endpoint Transient Ischemic Attack (TIA) ^† 1	1/418 (0.24%)
Presyncope ^† 1	1/418 (0.24%)
Radiculopathy ^† 1	1/418 (0.24%)
Stroke ^† 1	2/418 (0.48%)
Syncope ^† 1	2/418 (0.48%)
Renal and urinary disorders
Hematuria ^† 1	1/418 (0.24%)
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis ^† 1	1/418 (0.24%)
Chronic Obstructive Pulmonary Disease (COPD) ^† 1	1/418 (0.24%)
Dyspnea ^† 1	1/418 (0.24%)
Idiopathic Interstitial Lung Diseases ^† 2	1/418 (0.24%)
Pleural Effusion ^† 1	1/418 (0.24%)
Pulmonary Embolism ^† 1	1/418 (0.24%)
Respiratory Failure ^† 1	1/418 (0.24%)
Surgical and medical procedures
Elective Surgery ^† 1	1/418 (0.24%)
Vascular disorders
Arterial Hypertension/Hypertension ^† 1	2/418 (0.48%)
Hematoma ^† 1	5/418 (1.20%)
Hypotension ^† 1	2/418 (0.48%)
VASC Vessel Stenosis ^† 1	1/418 (0.24%)
Vessel Stenosis ^† 1	10/418 (2.39%)
1 Term from vocabulary, MedDRA 11.0 2 Term from vocabulary, MedDRA 10.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Optical Coherence Tomography (OCT)
	Affected / at Risk (%)
Total	128/418 (30.62%)
Blood and lymphatic system disorders
Anemias ^† 2	1/418 (0.24%)
Iron-Deficiency Anemia ^† 2	1/418 (0.24%)
Cardiac disorders
Angina Pectoris ^† 2	1/418 (0.24%)
Atrial Fibrillation ^† 2	1/418 (0.24%)
Hypokinetic Septal Motion ^† 2	1/418 (0.24%)
Mitral Valve Regurgitation/Mitral Insufficiency ^† 2	1/418 (0.24%)
Palpitations ^† 1	2/418 (0.48%)
Premature Ventricular Contraction ^† 2	1/418 (0.24%)
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia) ^† 2	1/418 (0.24%)
Tachycardia ^† 2	1/418 (0.24%)
Unsustained/Nonsustained Ventricular Tachy/Cardiac Arrhythmia ^† 2 [1]	1/418 (0.24%)
Ear and labyrinth disorders
Dizziness ^† 1	5/418 (1.20%)
Endocrine disorders
Hyperglycemia ^† 2	2/418 (0.48%)
Eye disorders
Blurred Vision ^† 2	1/418 (0.24%)
Conjunctivitis ^† 2	2/418 (0.48%)
Dry Eyes ^† 2	1/418 (0.24%)
Eye Infection ^† 2	1/418 (0.24%)
Visual Disturbance ^† 2	2/418 (0.48%)
Gastrointestinal disorders
Acute Pancreatitis ^† 2	1/418 (0.24%)
Constipation ^† 2	3/418 (0.72%)
Diarrhea ^† 2	2/418 (0.48%)
Diverticulitis ^† 2	1/418 (0.24%)
Dyspepsia ^† 2	1/418 (0.24%)
Dysphagia ^† 2	1/418 (0.24%)
Gastroesophageal Reflux Disease ^† 2	1/418 (0.24%)
Hiatus Hernia ^† 2	1/418 (0.24%)
Ingestion ^† 2	1/418 (0.24%)
Viral Gastroenteritis ^† 2	1/418 (0.24%)
General disorders
Abdominal Pain ^† 1	1/418 (0.24%)
Abrasion ^† 2	1/418 (0.24%)
Apnea ^† 2	1/418 (0.24%)
Back Pain ^† 2	1/418 (0.24%)
Callus ^† 2	1/418 (0.24%)
Chest Pain ^† 2	18/418 (4.31%)
Chest Tightness ^† 2	4/418 (0.96%)
Edema ^† 2	3/418 (0.72%)
Fatigue/Generalized Fatigue ^† 2	10/418 (2.39%)
Hip Pain ^† 2	5/418 (1.20%)
Knee Pain ^† 2	5/418 (1.20%)
Lacerations ^† 2	1/418 (0.24%)
Melena ^† 2	1/418 (0.24%)
Myalgias ^† 2	1/418 (0.24%)
Nausea ^† 2	1/418 (0.24%)
Neck Pain ^† 2	1/418 (0.24%)
Obstructive Sleep Apnea ^† 2	2/418 (0.48%)
Other ^† 2	14/418 (3.35%)
Pain ^† 2	5/418 (1.20%)
Post-Nasal Drainage ^† 2	1/418 (0.24%)
Swelling ^† 2	1/418 (0.24%)
Tooth Infection ^† 2	1/418 (0.24%)
Toothache ^† 2	1/418 (0.24%)
Weakness ^† 2	1/418 (0.24%)
Immune system disorders
Allergy ^† 2	1/418 (0.24%)
Infections and infestations
Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus ^† 2	1/418 (0.24%)
Common Cold/Upper Respiratory Tract Infection ^† 2	6/418 (1.44%)
Fever ^† 2	3/418 (0.72%)
Injury, poisoning and procedural complications
Rib Fracture ^† 2	1/418 (0.24%)
Trauma ^† 2	1/418 (0.24%)
Investigations
Abnormal Lab Value ^† 2	1/418 (0.24%)
EKG Abnormalities ^† 2	4/418 (0.96%)
Hypokalemia ^† 2	1/418 (0.24%)
Hyponatremia ^† 2	1/418 (0.24%)
Peak T Waves ^† 2	1/418 (0.24%)
Musculoskeletal and connective tissue disorders
Arm Fracture ^† 2	2/418 (0.48%)
Arm Pain ^† 2	1/418 (0.24%)
Bursitis ^† 2	1/418 (0.24%)
Gout ^† 2	1/418 (0.24%)
Low Back Pain ^† 2	4/418 (0.96%)
Muscle Strain ^† 2	1/418 (0.24%)
Musculoskeletal Pain ^† 2	5/418 (1.20%)
Wrist Sprain ^† 2	1/418 (0.24%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer ^† 2	1/418 (0.24%)
Cyst ^† 2	1/418 (0.24%)
Nervous system disorders
Carpal Tunnel ^† 2	1/418 (0.24%)
Fainting/Blackout ^† 2	1/418 (0.24%)
Headache ^† 2	3/418 (0.72%)
Syncope ^† 2	1/418 (0.24%)
Vaso Vagal Response ^† 2	1/418 (0.24%)
Vertigo ^† 2	1/418 (0.24%)
Psychiatric disorders
Anxiety ^† 2	1/418 (0.24%)
Depression ^† 2	1/418 (0.24%)
Renal and urinary disorders
Chronic Renal Failure ^† 2	1/418 (0.24%)
Dysuria ^† 2	1/418 (0.24%)
Hematuria ^† 2	4/418 (0.96%)
Nephrolithiasis ^† 2	1/418 (0.24%)
Urinary Tract Infections ^† 2	4/418 (0.96%)
Reproductive system and breast disorders
Prostatitis ^† 2	1/418 (0.24%)
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis ^† 2	1/418 (0.24%)
Asthma ^† 2	1/418 (0.24%)
Chronic Obstructive Pulmonary Disease (COPD) ^† 2	4/418 (0.96%)
Cough ^† 2	3/418 (0.72%)
Difficulty Catching Breath ^† 2	1/418 (0.24%)
Dyspnea ^† 2	14/418 (3.35%)
Pneumonia ^† 2	1/418 (0.24%)
Sinusitis ^† 2	1/418 (0.24%)
Skin and subcutaneous tissue disorders
Bruise/Purpura Simplex ^† 2	2/418 (0.48%)
Cellulitis ^† 2	1/418 (0.24%)
Rash ^† 2	4/418 (0.96%)
Skin Bruise ^† 2	1/418 (0.24%)
Skin Lesions ^† 2	2/418 (0.48%)
Vascular disorders
Aortic Aneurysms ^† 2	1/418 (0.24%)
Arterial Hypertension/Hypertension ^† 2	5/418 (1.20%)
Arteriovenous (AV) Fistula ^† 2	1/418 (0.24%)
Bleeding ^† 2	2/418 (0.48%)
Hematoma ^† 2	1/418 (0.24%)
Orthostatic Hypotension ^† 2	1/418 (0.24%)
Renal Artery Stenosis ^† 2	1/418 (0.24%)
Thrombus ^† 2	1/418 (0.24%)
VASC Bruise ^† 2	1/418 (0.24%)
VASC Hematoma ^† 2	1/418 (0.24%)
VASC Pseudoaneurysm ^† 2	1/418 (0.24%)
VASC Vessel Stenosis ^† 2	1/418 (0.24%)
Vessel Stenosis ^† 2	3/418 (0.72%)
1 Term from vocabulary, MedDRA 10.0 2 Term from vocabulary, MedDRA 11.0 † Indicates events were collected by systematic assessment [1] Unsustained/Nonsustained Ventricular Tachy/Cardiac Arrhythmia includes: Other - Non-sustained runs of VT, Ventricular Ectopic Beats/Premature Ventricular Contractions/Premature Ventricular Beats

Limitations and Caveats

Patients with acute STEMI, left main PCI, severe chronic kidney disease, and other high-risk features were excluded. No prescriptive recommendations were provided in the protocol, a wide variation in physician behavior was expected and observed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Proposals for all publications, abstracts, presentations, or journal manuscripts arising from, or related to the Study will be submitted for approval to the Publications Committee. Accordingly, decisions on timing and content of publications and presentations from the Study will be coordinated with the Study Publication Committee and Sponsor.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Sr. Manager, Global Clinical Affairs
Organization:	St. Jude Medical
Phone:	651-756-5585
EMail:	mwagner2@sjm.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wijns W, Shite J, Jones MR, Lee SW, Price MJ, Fabbiocchi F, Barbato E, Akasaka T, Bezerra H, Holmes D. Optical coherence tomography imaging during percutaneous coronary intervention impacts physician decision-making: ILUMIEN I study. Eur Heart J. 2015 Dec 14;36(47):3346-55. doi: 10.1093/eurheartj/ehv367. Epub 2015 Aug 4.

Layout table for additonal information

Responsible Party:	Abbott Medical Devices
ClinicalTrials.gov Identifier:	NCT01663896
Other Study ID Numbers:	SJM-CVD-0612
First Submitted:	August 7, 2012
First Posted:	August 13, 2012
Results First Submitted:	June 22, 2016
Results First Posted:	July 2, 2020
Last Update Posted:	July 2, 2020

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