Primary Objective: To demonstrate the safety and efficacy of an OCT guided strategy for stent implantation.Trial Hypothesis: OCT-guided stent placement with application of a novel algorithm is non-inferior to IVUS-guided stent placement and superior…
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Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Efficacy Endpoint (powered).
Post-PCI MSA assessed by OCT in each randomized arm, measured at the
independent OCT core laboratory blinded to imaging modality assignment.
Testing will be done in a hierarchal manner as follows:
1. Non-inferiority of OCT guided stenting vs. IVUS guided stenting
2. Superiority of OCT guided stenting vs. Angiography guided stenting
3. Superiority of OCT guided stenting vs. IVUS guided stenting
Primary Safety Endpoint (non-powered).
Procedural MACE defined as procedural complications (angiographic dissection,
perforation, thrombus, and acute closure) requiring active interventions
(prolonged balloon inflations, additional stent implantation, or
pericardiocentesis).
Secondary outcome
Imaging measures by OCT in each study arm
1) Acute procedural success
2) Post-PCI stent expansion (%)
3) Mean stent expansion (%)
4) Intra-stent plaque protrusion and thrombus
5) Untreated reference segment disease
6) Edge dissections
7) Stent Malapposition
8) Border detection (OCT arm only)
9) Altered clinical decision making on the basis of the post-stent imaging run
10) Intra-stent Lumen Area (Intra-stent Flow Area)
11) Effective Lumen Area (Total Flow Area)
12) IVUS vs. OCT detected:
A) Malapposition (Major, Minimal, All) (%)
B) Dissection (Major, Minor, All) (%)
C) Protrusion (Major, Minor, All) (%)
Non OCT Secondary Endpoints
Angiographic Endpoints (QCA)
1) Minimal lumen diameter
2) Percent diameter stenosis
3) Acute lumen gain post-intervention
4) Maximum stent size/reference vessel diameter ratio
5) Angiographic Dissection >= NHLBI type B
Procedural Endpoints (site reported):
1) Total Stent Length
2) Total number of stents
3) Maximal Stent Size
4) Post dilatation inflations (yes/no)
5) Maximum inflation pressure (atm.)
6) Additional interventions on the basis of the post stent imaging run:
A) Use of larger balloon
B) Use of higher inflation pressures
C) Use of additional inflations
D) Use of additional stent(s)
E) Thrombus aspiration
F) Other interventions
Additional Procedural and Clinical Endpoints
1) Angiography defined procedural success rate
2) Device success rate (site reported)
3) Target Lesion Failure at 1 year defined as cardiovascular death, target
vessel myocardial infarction, or ischemia driven target-lesion
revascularization.
4) Peri-procedural myocardial infarction.
Background summary
Angiography remains the primary method of imaging the coronary artery
vasculature to guide clinical decision-making and PCI strategy. However
angiography has a number of well-known limitations. Angiography provides a
2-dimensional representation of a complex 3-dimensional structure. Moreover,
the angiogram displays only luminal dimensions and characteristics, without
information on vascular remodeling, plaque distribution and eccentricity, or
detailed delineation of the extent of disease. The ability of angiography to
accurately characterize plaque and tissue types including calcification, lipid
and thrombus is poor. Operator assessment of lesion severity both before and
after PCI is notoriously inaccurate. Although quantitative coronary angiography
is able to reduce intra-observer and inter-observer variability, it is
cumbersome and rarely performed (at least in the US), and is unable to overcome
other inherent limitations of the technique.Angiography is also suboptimal in
its ability to identify post PCI complications such as stent underexpansion or
malapposition, residual dissections or thrombus, and plaque prolapse.
These limitations of angiography may be overcome in part by intravascular
ultrasound (IVUS), which allows tomographic cross-sectional imaging of the
vessel wall. IVUS determination of the minimum stent area as well as residual
plaque burden and dissections at the stent margins have been shown in numerous
studies to be independent predictors of both restenosis and stent thrombosis.
Meta-analyses of randomized and registry studies of IVUS-guided vs.
angiography-guided PCI have suggested that IVUS guidance may decrease
restenosis and TVR (Target Vessel Revascularisation) after treatment with BMS,
and restenosis, TVR, stent thrombosis, and death after treatment with DES. The
large-scale ADAPT-DES study demonstrated that IVUS guidance leads to larger
stent expansion and use of longer stents, with associated reductions in stent
thrombosis, MI, TLR (Target Lesion Revascularisation) and cardiac death.
Nonetheless, IVUS has limited axial resolution (150-200 µm), is unable to image
behind calcium, poorly discriminates thrombus and other plaque subtypes, is
unable to assess fibrous cap thickness with resolution sufficient to identify
vulnerable plaque, and is limited by the photoacoustic properties of sound and
therefore requires slow pullback. Radiofrequency IVUS is more accurate than
grayscale IVUS for plaque characterization, but is currently used principally
as a research tool, and has not been demonstrated to further enhance stent
procedures.
Optical coherence tomography (OCT) is a newer intravascular imaging modality
that provides high-resolution (10-20 µm) cross-sectional images of plaque
microarchitecture, stent placement and size, apposition, and strut coverage.
Second-generation frequency domain (FD)-OCT allows for rapid pullback during
blood clearance of the vessel, and has been used to image microstructural
details, which correlate closely to histopathology. Specifically, compared to
IVUS, OCT offers greater dimensional measurement accuracy, and is able to more
accurately identify thrombus, lipid, calcium, fibrous cap thickness,
dissections, plaque prolapse, stent malapposition and strut coverage. However,
despite the greatly improved resolution of OCT compared to IVUS, the
penetration depth of OCT is limited, and as such the full thickness of the
vascular wall may not be visible. The impact of this limitation is unclear.
In a cross-over study design, Habara and colleagues reported that compared to
OCT-guided PCI, IVUS-guided PCI resulted in a significantly greater minimum
stent area (MSA), the most important single determination of restenosis and
stent thrombosis. Multiple strategies to optimize stent implantation using OCT
have been proposed but none as of yet has gained universal agreement among
interventional cardiologists and broad adoption. The lack of randomized studies
demonstrating that patient outcomes of OCT-guided stenting are at least as good
as with IVUS-guided stenting represents major hurdles for the adoption of this
technology. We therefore developed an algorithm to use OCT to optimize coronary
stent implantation and in this study will compare its outcomes to those
achieved with IVUS as well as those achieved with angiography.
Study objective
Primary Objective:
To demonstrate the safety and efficacy of an OCT guided strategy for stent
implantation.
Trial Hypothesis:
OCT-guided stent placement with application of a novel algorithm is
non-inferior to IVUS-guided stent placement and superior to Angiography, all as
measured by post-PCI minimum stent area (MSA).
Study design
The present study is a prospective, post-market, international, multi-center,
randomized trial aimed at demonstrating whether a practical strategy of
OCT-guided stent implantation can result in similar immediate post-PCI stent
lumen dimensions as achieved with IVUS-guidance, and superior results to those
achieved with angiography.
Approximately 35 sites in the United States and outside the United States will
participate in this study of 420 subjects.
Study burden and risks
An extra OCT catheter is used after stent placement in patients who will be
randomized to the Angiography and IVUS arm. This is done to generate additional
OCT images for study purposes. The risk of the insertion of an additional
catheter is minimal during this procedure.
For the rest of the procedure the usual risks of PCI treatment apply.
Participation is justified because the research brings almost no extra burden
for the patient. The extra-OCT catheter which is used in the angiography and
IVUS arm gives a minimal additional risk during the PCI procedure. The
randomization to different standard of care visualization techniques brings no
additional risk to the patient. These three techniques are already widely used
in hospitals.
It could be that the PCI procedure takes longer because more measurements are
done.
The burden for the patient is minimal compared to the scientific value of this
study.
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Standaardruiter 13
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Listed location countries
Age
Inclusion criteria
General Inclusion Criteria:
1) Age >= 18 years.
2) Patient with an indication for PCI
3) Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES);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) Total lesion length <40mm
Exclusion criteria
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 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53487.078.15 |