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In calcified lesions, optimal stent placement and expansion may prove to be challenging. Lesion preparation is necessary to facilitate optimal stenting in calcified lesions, for which orbital atherectomy can used. Therefore the aim of this study is to:
Patients presenting with a significant and severely calcified lesion in need of orbital atherectomy will undergo optical coherence tomography guided orbital atherectomy and stent placement.
The Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems Inc., St. Paul,MN,USA) is a percutaneous device indicated to modify calcified lesion in order to facilitate stent delivery in patients with severely calcified coronary artery disease (CAD). As of to date, detailed sequential intravascular imaging data unraveling the exact calcium modifying effect of orbital atherectomy (OA) prior to stent placement in vivo, are lacking.
The aim of this, international, multicenter, prospective and observational single arm study is to understand the mechanism of action of OA for the treatment of de novo, severely calcified coronary lesions priot to stent placement using optical coherence tomography (OCT) and to assess stent expansion, based on OCT derived minimal stent area. The study population consists of patients undergoing percutaneous coronary intervention of a severely calcified coronary lesion in need of OA to enable proper stent placement and expansion.
A total of 100 patients will be enrolled. All patients will undergo peri-procedural imaging using OCT and the aim is to obtain data for at least 50 patients with OCT before and after OA and after stenting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational cohort | Patients undergoing PCI of a severely calcified coronary lesion in need of OA to enable proper stent placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orbital Atherectomy | Device | The Diamondback 360° Coronary orbital atherectomy system (OAS) is a device dedicated to debulk severely calcified coronary lesions to facilitate stent delivery and enable stent expansion with optimal results. The OAS's main mechanism is the synergistic rotation of the crown around its axis and simultaneously its endoluminal orbital motion. This effect allows blood to flow continuously and it facilitates heat dispersion which results in reduced heat damage to the arterial walls and subsequently to less myocardial damage, at the same time it softens the plaques tissue. It also appears that the microparticles created from sanding the artery plaques do not create any agglomeration to the branching arteries |
| Measure | Description | Time Frame |
|---|---|---|
| Primary imaging endpoint | Proportion of patients that reach stent expansion ≥ 5.5mm² as assessed by OCT derived MSA | Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | Procedural success is defined as successful stent delivery with:
| Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing PCI of severely calcified coronary lesion in need of orbital atherectomy to enable proper stent placement and expansion
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | South Holland | 3015GE | Netherlands |
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| Target vessel failure (TVF) | TVF is defined as a composite of cardiac death, target vessel spontaneous myocardial infarction and target vessel revascularization. | Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months |
| Major adverse cardiac events (MACE) | MACE is defined is a composite of all-cause death, spontaneous myocardial infarction and repeat revascularization | Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months |
| Individual components of MACE and TVF | The components of MACE and TVF will be measured individually, namely:
| Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months |
| Periprocedural myocardial infarction | The incidence of periprocedural myocardial infarction, namely type 4a (4th universal definition of myocardial infarction) | Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours |
| Major intraprocedural complications | Major intraprocedural complications include type C-F dissections, perforations, slow flow or no reflow, thrombus and major side branch occlusion (> 2mm) | Periprocedure |
| Probable and definite stent thrombosis | Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months |
| MSA on OCT | Final MSA | Periprocedure |
| Stent expansion on OCT | Percentage of stent expansion | Periprocedure |
| Intracoronary imaging endpoints on OCT | Minimal lumen area post orbital atherectomy and post stenting | Periprocedure |
| Calcium and fractures on OCT |
| Periprocedure |
| Hematoma on OCT |
| Periprocedure |
| Diameter stenosis on angiography | - In-stent and in-segment DS | Periprocedure |
| minimal luminal diameter Diameter on angiography | - In-stent and in-segment MLD | Periprocedure |
| Acute gain Diameter on angiography | - In-stent and in-segment acute gain | Periprocedure |
| ID | Term |
|---|---|
| D061205 | Vascular Calcification |
| ID | Term |
|---|---|
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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