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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The study aims to assess contemporary practice in OCT use during routine interven-tional practice and to assess the impact of the MLD-MAX algorithm on real-world PCI in a large unselected European all-comer-study cohort.
Angiography is the current standard method to guide PCI strategy in clinical practice. However, angiography has a number of well-described limitations, primarily through only providing an assessment of luminal dimensions without delineation of the burden of atheroma-tous disease. Angiography also provides suboptimal assessment of post PCI complications such as stent underexpansion or malapposi-tion, residual dissections or thrombus, and tissue prolapse. These limi-tations may be overcome in part by intravascular imaging (IVI), which allows tomographic, cross-sectional imaging of the vessel wall. Meta-analyses of randomized and registry studies of IVI-guided vs. angi-ography-guided PCI have suggested that IVI-guidance may improve clinical outcome following PCI.
Optical coherence tomography (OCT) provides high-resolution (10-20 μm) cross-sectional images of plaque microarchitecture, stent place-ment and size and strut coverage. Recently the MLD-MAX algorithm was developed to guide and stand-ardize coronary stent implantation based on sizing of the vessel at the proximal and distal reference using the EEL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study population (cohort) | No study arms; one patient population will be observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention planned | Other | No intervention planned; study is observational |
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| Measure | Description | Time Frame |
|---|---|---|
| Stent expansion: number of participants with optimal / acceptable / unacceptable stent expansion | Stent expansion is defined by the MSA achieved in the proximal and distal stented segments relative to their respective reference lumen areas. Stent expansion will be categorised as follows: Optimal stent expansion (y/n); acceptable stent expansion (y/n); unacceptable stent expansion (y/n); post-PCI stent expansion (%). | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Stent Area (MSA) | Imaging Outcome: minimal stent area as continuous measure; Final Post-PCI MSA (per target lesion basis) assessed by final-OCT after PCI; measured at an independent OCT core laboratory. Imaging-Outcome: Minimal-Stent-Area (MSA), continuous measure | At baseline |
| Mean stent expansion |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with evidence of myocardial ischemia (e.g. stable angina, silent ischemia, unstable angina, or acute myocardial infarction) un-dergoing OCT-guided lesion evaluation.
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| Name | Affiliation | Role |
|---|---|---|
| David-Manuel Leistner, Prof Dr med | Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie | Principal Investigator |
| Thomas Johnson, Dr med | Bristol Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Frankfurt - Med. Klinik 3 - Kardiologie | Frankfurt am Main | 60590 | Germany |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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The mean stent area (stent volume/analyzed stent length) divided by the average of proximal and distal reference lumen areas x 100 |
| At baseline |
| Intra-stent plaque protrusion and thrombus: number of major and minor protusion area / stent area | Defined as a mass attached to the luminal surface or floating within the lumen, meeting the following criteria: Protrusion/thrombus is defined as any intraluminal mass protruding at least 0.2 mm within the luminal edge of a stent strut, and will be further classified as Major and Minor:
| At baseline |
| Number of participants with untreated reference segmant disease | Defined as focal disease with untreated MLA <4.5 mm2 within 5 mm from the proximal and/or distal stent edges. Sub-classified by the amount of untreated lipid plaque, divided into 3 grades: Low (≤90° of lipid arc), Medium (>90°-<180° of lipid arc) and High (≥180° of lipid arc). | At baseline |
| Number of participants with major and minor edge dissections | Edge dissections will be tabulated as:
| At baseline |
| Number of participants with major and minor stent malapposition | Defined as frequency (%) of incompletely apposed stent struts (defined as stent struts clearly separated from the vessel wall (lumen bor-der/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:
| At baseline |
| Number of participants with procedural complications | Defined as prolonged ST-segment elevation or depression (>30 minutes), cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemody-namic support or intubation or procedural death | At baseline |
| Number of participants with adverse events | Target lesion failure (TLF; cardiac death, TV-MI or ischemia-driven target lesion revascularization) | At 30 days follow-up |
| Number of participants with adverse events | Target lesion failure (TLF; cardiac death, TV-MI or ischemia-driven target lesion revascularization) | At 6 months follow-up |