An observational study in Vascular Calcification* / Diagnostic Imaging, Atherectomies, Coronary and Tomography, Optical Coherence, sponsored by Erasmus Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Erasmus Medical Center · Observational
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.
82 studies on the registry are indexed under Vascular Calcification; 17 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 23 observational studies indexed under Vascular Calcification.
Browse Vascular Calcification studies →Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
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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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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing PCI of a severely calcified coronary lesion in need of OA to enable proper stent placement
Device: Orbital Atherectomy
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
Also known as: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Primary imaging endpoint
Proportion of patients that reach stent expansion ≥ 5.5mm² as assessed by OCT derived MSA
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Procedural success
Procedural success is defined as successful stent delivery with: 1. Final core lab defined TIMI III flow 2. Angiographic in-stent DS ≤20% 3. absence of in-hospital major adverse cardiac and cerebrovascular events (consisting of all-cause death, spontaneous myocardial infarction, target vessel revascularization or stroke)
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Target vessel failure (TVF)
TVF is defined as a composite of cardiac death, target vessel spontaneous myocardial infarction and target vessel revascularization.
Time frame: 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 frame: 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: * All-cause death * Cardiac death * Spontaneous myocardial infarction * Target vessel spontaneous myocardial infarction * Target vessel revascularization * Repeat revascularization
Time frame: 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 frame: 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)
Time frame: Periprocedure
Probable and definite stent thrombosis
Time frame: 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
Time frame: Periprocedure
Stent expansion on OCT
Percentage of stent expansion
Time frame: Periprocedure
Intracoronary imaging endpoints on OCT
Minimal lumen area post orbital atherectomy and post stenting
Time frame: Periprocedure
Calcium and fractures on OCT
* Number of calcium fractures * Number of calcium factures based on calcium thickness post orbital atherectomy * Number of calcified nodules modified post orbital atherectomy
Time frame: Periprocedure
Hematoma on OCT
* Incidence of OCT defined hematomas post orbital atherectomy * Incidence and quantifications of dissections post orbital atherectomy
Time frame: Periprocedure
Diameter stenosis on angiography
- In-stent and in-segment DS
Time frame: Periprocedure
minimal luminal diameter Diameter on angiography
- In-stent and in-segment MLD
Time frame: Periprocedure
Acute gain Diameter on angiography
- In-stent and in-segment acute gain
Time frame: Periprocedure
Start is estimated for Mar 2024; primary completion for Apr 2025, 12 months later.
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