To define and evaluate OCT stent guidance parameters through prospective data collection in PCI procedures of de novo lesions.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Identify OCT peri-procedural guidance parameter(s) for stent implantation that
relates with patient outcomes in the hospital, at 30 days, and 12 months post
intervention.
(No formal hypothesis will be tested as this is an observational study.)
Secondary outcome
- Assessment of impact of OCT on physician decision-making pre and post PCI.
- Correlation/relationship of OCT parameters, as defined by OCT volumetric
analysis, on pre and post intervention FFR values.
- Consideration of health economics data and resource utilization
(No formal hypothesis will be tested as this is an observational study.)
Background summary
Since its introduction in 1977, percutaneous coronary intervention (PCI) has
drastically evolved, achieving high rates of safety and efficacy, and has
turned into the predominant revascularization modality for the treatment of
coronary artery disease. Intravascular imaging has been of fundamental
importance in the understanding and refinement of percutaneous interventional
procedures.
Optical Coherence Tomography (OCT) is a new imaging modality which visualizes
the coronary artery pre- and post-stenting. Beside OCT there are different
imaging techniques used. However, OCT is a new visualization technique that
gives the physician more information than other techniques till thus far. OCT
is a post-marketing technique that is already implemented in the hospitals.
Intravascular Fourier-domain optical coherence tomography (FD-OCT) permits the
acquisition
of longitudinal sequences of cross-sectional images with significantly faster
pullback speeds in comparison to IVUS and the first generation time-domain OCT
(TD-OCT). In addition, FD-OCT acquires images in a blood free environment which
result in a very sharp border between lumen and vessel wall. These and other
more technical characteristics permits more rational criteria for optimal
stenting.
There is a need to identify new optimalisation parameters for stenting,
benefitting from the unique 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.
As a secondary endpoint the impact of OCT findings on operator decision making
and the correlation between FFR and OCT values at pre and post PCI will be
evaluated. FFR measurements will measure the flow blockage in the coronary
vessels pre and post PCI (FAME I and FAME II trials).
The OCT and FFR measurement will be performed using the ILUMIEN system. This
system is the first to combine the functional modality of fractional flow
reserve and anatomical modality of optical coherence tomography technologies.
It includes a user interface which allows users to perform OCT imaging or FFR
assessment from the same console. The ILUMIEN System is further described in
Appendix A.
Protocol page 11-13
Study objective
To define and evaluate OCT stent guidance parameters through prospective data
collection in PCI procedures of de novo lesions.
Study design
Patients will be selected for PCI, this procedure will be performed within the
ILUMIEN I study. During the procedure the findings on the operator decision
making will be documented and OCT and FFR data will be collected. The collected
data will be used to identify OCT stent guidance parameters, which will be
prospectively tested in a second stage II protocol. Follow-up visits are
scheduled at pre-discharge, after 30 days, 6 months and 12 months. During this
visits study activities are performed and a quality of life questionnaire will
be collected.
Protocol page 21 depicts the produre flow. The schedule of assessments is
depicted on page 30 and 31 of the protocol
Study burden and risks
This is a prospective observational study of market released product(s). The
potential benefit of
participating in this observational study with standard of care treatment is
that subjects will be
closely followed, and data from this study may enhance future treatment for PCI
patients. However, it could be that the amount of time for the PCI is higher
due to more OCT and FFR measurements and the precise documentation of the
impact of OCT on physician decision-making pre and post PCI.
The risk of the patients is equal than the risks of a PCI per standard of care
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Listed location countries
Age
Inclusion criteria
1. Age >= 18 years
2. Patient provides signed written informed consent before any studyspecific procedure
3. De novo coronary artery disease in target vessel
4. Single of 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 in considered part of the vessel.
5. Elective or ad hoc PCI, stabe angina, acute coronary syndrome (unstable angina and NSTEMI)
6. Angiographically significant (>50% visiual 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. Plannen use of bare metal stent
5. Known renal insufficiency (examples being but not limited to eGFR<60ml/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. Extrene angulation (>90%) or excessive tortuosity (>45degree angles) proximal to or within the target lesion
8. Vessel(s) and lesion(s) non amenable for PC, for examples diffuse disease
9. Anu other medical condition that in the opinion of the investigator will interfere with patient safety or study results
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 |
|---|---|
| ClinicalTrials.gov | NCT01663896 |
| CCMO | NL42686.078.12 |