Coronary Artery Disease (CAD) Clinical Trial
Official title:
Comparison of Orbital Versus Rotational Atherectomy Effects On Coronary Microcirculation in Percutaneous Coronary Intervention (PCI)
The investigators hypothesize that the orbital atherectomy system (OAS), a newer generation atherectomy device, reduces the incidence of microcirculatory compromise as compared to older generation rotational atherectomy (RA) due to differences in the mechanism of athero-ablation.
The presence of heavily calcified coronary lesions necessitates the use of ablative devices
that aid in successful percutaneous coronary intervention (PCI). However, atherectomy devices
generate microparticles that embolize to the distal coronary microcirculation and may
compromise myocardial tissue perfusion.
Two mechanisms that deserve particular attention are the eccentric mounting of the OAS crown
and the higher flow rates on the vasodilator flush. Firstly, as opposed to rotational
atherectomy where the larger, centrally mounted burr may cause obstruction of flow during the
atherectomy, the smaller eccentrically mounted crown in OAS allows continuous perfusion
during both atherectomy as well as rest periods. Second, both during rest and atherectomy,
the flow rates of vasodilatory flush is higher in OAS compared to RA. Combined, these
differences in coronary and vasodilator flush flow could lead to improved perfusion of the
distal circulation, particularly during the atherectomy runs when risk of embolization is
highest.
The loss of microcirculatory function can be transient, with partial or complete restoration
of microcirculatory blood flow, or permanent. As shown in studies of patients with acute
coronary syndromes, the loss of microcirculatory function is a critical and independent
predictor of myocardial recovery and adverse outcomes. The putative protective effects of OAS
on coronary microvasculature may therefore be of major clinical significance and impact.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05292079 -
CAPTURER PMCF Study ( rEPIC04D )
|
||
| Recruiting |
NCT05292118 -
Navitian PMCF Study ( rEPIC04C )
|
||
| Recruiting |
NCT05292014 -
ANGIOLITE PMCF Study ( rEPIC04F )
|
||
| Recruiting |
NCT05292092 -
Essential Pro PMCF Study ( rEPIC04E )
|
||
| Completed |
NCT05292105 -
NC Xperience PMCF Study( rEPIC04B)
|
||
| Completed |
NCT01435031 -
EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions
|
N/A | |
| Terminated |
NCT01443754 -
Hybrid Revascularisation by Combined Coronary Artery Bypass Graft (CABG) and PCI in Multivessel Coronary Disease
|
N/A | |
| Completed |
NCT00783302 -
Study in Subjects Suspected of Having CAD Undergoing VISIPAQUE-enhanced CCTA as Part of Their Routine Medical Care
|
N/A | |
| Completed |
NCT00543400 -
Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)
|
Phase 2 | |
| Completed |
NCT05516784 -
Impact of CYP2C19 Genotype-guided Clopidogrel and Ticagrelor Treatment on Platelet Function Test and Metabolomics Profile
|
Phase 4 | |
| Completed |
NCT02873052 -
MyoVista Measurements in Patients With Atherosclerosis and CAD
|
||
| Terminated |
NCT02984891 -
Optical Coherence Tomography (OCT) Intravascular Ultrasound (IVUS) Dual Imaging
|
||
| Completed |
NCT05292144 -
Xperience Pro PMCF Study
|
||
| Completed |
NCT02554292 -
Post Market Surveillance of SeQuent Please Neo With Scoring Balloon
|
||
| Active, not recruiting |
NCT06052319 -
A Study to Assess the Engagement and Usefulness of Care4Today Digital Platform for Disease Management in Coronary Artery Disease (CAD) and/or Peripheral Artery Disease (PAD) Population
|
||
| Completed |
NCT00265525 -
Evaluation of a Web-based Intervention to Promote Physical Activity in Patients With Heart Disease.
|
Phase 3 | |
| Completed |
NCT03570697 -
Imaging of Coronary Plaques in Participants Treated With Evolocumab
|
Phase 3 | |
| Terminated |
NCT05508893 -
Screening for Coronary Artery Disease USing Primary Evaluation With Coronary CTA in Aviation Medicine (SUSPECT)
|
N/A | |
| Completed |
NCT02341664 -
Patient and Provider Assessment of Lipid Management Registry
|
||
| Completed |
NCT02098772 -
Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
|
Phase 3 |