Coronary Artery Disease
Conditions
Keywords
OCT, FFR, percutaneous coronary intervention
Brief summary
The purpose of this study is to define and evaluate optical coherence tomography (OCT) stent guidance parameters through prospective data collection in percutaneous coronary intervention (PCI) procedures of de novo lesions.
Detailed description
Optical coherence tomography (OCT) is an imaging modality that uses near-infrared light to produce high resolution, real-time images that are clearer and more quickly produced than those produced by intravascular ultrasound (IVUS). OCT imaging is performed utilizing an imaging catheter with a single optical fiber core that both emits light and records its reflection while simultaneously rotating 360° during continuous pullback within the coronary artery. Fractional Flow Reserve (FFR) is a pressure-derived, lesion-specific, physiological index determining the hemodynamic severity of intracoronary lesions. FFR is measured by placing a pressure guidewire across the lesion of interest and pharmacologically inducing hyperemia. The ratio of distal to proximal pressure allows the physician to physiologically determine if the narrowing is the cause of ischemia. the goal of this study is to define new parameters for stent optimization, benefitting from the unique Fourier-domain (FD-OCT) capabilities. This stage I study will identify the parameters which will be prospectively tested in a second stage II protocol. In hospital, 30 day, and 12 month outcomes data will be correlated with OCT baseline findings in order to identify optimal stent implant parameters.
Interventions
DEVICEOCT stent guidance
Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. Patient provides signed written informed consent before any study-specific procedure. 3. De novo coronary artery disease in target vessel. 4. Single or multi vessel disease. For multi vessel disease up to two vessels and three lesions treated, with no more than two lesions per vessel. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel. 5. Elective or ad hoc PCI, stable angina, acute coronary syndrome (unstable angina and NSTEMI). 6. Angiographically significant (\>50% visual estimation) stenosis present in at least one native coronary artery. 7. Mandatory use of FFR and OCT pre and post PCI. PCI strongly recommended in subjects with an FFR ≤ 0.80 in target vessel.
Exclusion criteria
1. Subjects with STEMI, emergent PCI, or in cardiogenic shock. 2. Subjects with target left main lesion. 3. Subjects with restenosis or stent thrombosis in the target vessel. 4. Planned use of bare metal stent. 5. Known renal insufficiency (examples being but not limited to eGFR \< 60 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL, or on dialysis). 6. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left). 7. Extreme angulation (\> 90°) or excessive tortuosity (\> two 45° angles) proximal to or within the target lesion. 8. Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease. 9. Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results. 10. Currently participating in another clinical study that interferes with study results. 11. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. 12. Life expectancy less than 1 year. 13. Potential for non-compliance to protocol requirements and follow-up. 14. Planned or prior heart transplantation or listed for heart transplant. 15. Any condition that precludes the subject from undergoing PCI, for example subjects with heparin induced thrombocytopenia, or contrast allergy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | In-hospital until discharge | Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital. |
| Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | 12 months | Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT | 1 Year | 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 |
Countries
Australia, Austria, Belgium, Canada, China, Czechia, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom, United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Optical Coherence Tomography (OCT) Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI. | 418 |
| Total | 418 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Various reasons | 43 |
Baseline characteristics
| Characteristic | Optical Coherence Tomography (OCT) |
|---|---|
| Age, Continuous | 64.7 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment Australia | 11 Participants |
| Region of Enrollment Austria | 5 Participants |
| Region of Enrollment Belgium | 44 Participants |
| Region of Enrollment Canada | 4 Participants |
| Region of Enrollment China | 25 Participants |
| Region of Enrollment Czechia | 14 Participants |
| Region of Enrollment France | 5 Participants |
| Region of Enrollment Germany | 6 Participants |
| Region of Enrollment Italy | 32 Participants |
| Region of Enrollment Japan | 97 Participants |
| Region of Enrollment Netherlands | 4 Participants |
| Region of Enrollment Spain | 11 Participants |
| Region of Enrollment United Kingdom | 7 Participants |
| Region of Enrollment United States | 153 Participants |
| Sex: Female, Male Female | 104 Participants |
| Sex: Female, Male Male | 314 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 418 |
| other Total, other adverse events | 128 / 418 |
| serious Total, serious adverse events | 112 / 418 |
Outcome results
Primary
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital.
Time frame: In-hospital until discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Device-oriented MACE (Cardiac death) | 0 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Device-oriented MACE(MI-AEC definition) | 6.7 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Device-oriented MACE(MI-3rd Universal definition) | 6.2 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Device-oriented MACE(TLR) | 0.2 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Patient-oriented MACE(All-cause mortality) | 0.2 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Patient-oriented MACE(MI-ARC Definition) | 6.7 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Patient-oriented MACE(MI-3rd Universal definition) | 6.2 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Patient-oriented MACE(Any Revascularization) | 0.2 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Stent Thrombosis(Definite) | 0 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Stent Thrombosis(Probable) | 0 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Stent Thrombosis(Possible) | 0 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Stent Thrombosis(Early) | 0 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Stent Thrombosis(Late) | 0 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Stent Thrombosis(Very Late) | 0 Percentage of per-subject incidence |
Primary
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 30 days
Time frame: 30 Days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Device-oriented MACE (Cardiac death) | 0 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Device-oriented MACE(MI-AEC definition) | 7.2 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Device-oriented MACE(MI-3rd Universal definition) | 6.7 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Device-oriented MACE(TLR) | 0.7 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Patient-oriented MACE(All-cause mortality) | 0.2 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Patient-oriented MACE(MI-ARC Definition) | 7.9 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Patient-oriented MACE(MI-3rd Universal definition) | 7.5 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Patient-oriented MACE(Any Revascularization) | 1.7 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Stent Thrombosis(Definite) | 0 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Stent Thrombosis(Probable) | 0 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Stent Thrombosis(Possible) | 0 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Stent Thrombosis(Early) | 0.2 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Stent Thrombosis(Late) | 0 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting | Stent Thrombosis(Very Late) | 0 Percentage of per-subject incidence |
Primary
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | Device-oriented MACE (Cardiac death) | 0 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | Device-oriented MACE(MI-AEC definition) | 8.3 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | Device-oriented MACE(MI-3rd Universal definition) | 7.8 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | Device-oriented MACE(TLR) | 2.5 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | Patient-oriented MACE(All-cause mortality) | 1.8 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | Patient-oriented MACE(MI-ARC Definition) | 9.3 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | Patient-oriented MACE(MI-3rd Universal definition) | 8.8 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | Patient-oriented MACE(Any Revascularization) | 5.5 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | Stent Thrombosis(Definite) | 0.3 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | Stent Thrombosis(Probable) | 0 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | Stent Thrombosis(Possible) | 0.5 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | Stent Thrombosis(Early) | 0.3 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | Stent Thrombosis(Late) | 0.5 Percentage of per-subject incidence |
| Optical Coherence Tomography (OCT) | Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) | Stent Thrombosis(Very Late) | 0 Percentage of per-subject incidence |
Secondary
Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Optical Coherence Tomography (OCT) | Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT | Physician decision-making (Post-PCI OCT) | 65 Percentage of participants |
| Optical Coherence Tomography (OCT) | Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT | Procedure Planning(Pre-PCI OCT) | 57 Percentage of participants |
| Optical Coherence Tomography (OCT) | Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT | Procedure Planning(Post-PCI OCT) | 27 Percentage of participants |
| Optical Coherence Tomography (OCT) | Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT | Physician decision-making (Pre-PCI OCT) | 65 Percentage of participants |