Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01342848
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2011-04-12
Brief Title:
Effectiveness of Thrombus Aspiration in Plaque Reduction for Patients With Acute Coronary Syndromes
Sponsor:
Raffaele De Caterina
Organization:
G dAnnunzio University
Study Overview
Official Title:
REduction of Myocardial Necrosis Achieved With Nose-dive Manual Thrombus Aspiration
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMNANT
Brief Summary:
Although successful percutaneous coronary interventions PCI with stent implantation may be hampered by periprocedural myocardial necrosis In acute ST-elevation myocardial infarction STEMI the reduction of thrombus burden through manual thrombus aspiration TA of an occluded coronary artery has been documented to produce an improved myocardial perfusion rate and significant survival advantage To date beyond feasibility and safety studies no clinical benefit has been yet documented with the use of TA before stent deployment in the setting of acute coronary syndromes ACS outside acute STEMI The investigators hypothesize that TA before stent deployment reduces the thrombusplaque burden - as assessed by intravascular imaging systems - in the setting of acute coronary syndromes ACS outside acute STEMI
Detailed Description:
Periprocedural myocardial infarction MI has an independent adverse prognostic relevance Several trials have documented a reduction in the occurrence of periprocedural MI through various pharmacological strategies with enhanced inhibition of platelet aggregation or high dose statins However real-world registries still document an incidence of periprocedural MI in 30-40 of patients Currently available intravascular imaging techniques Intravascular Ultrasound IVUS and more recently available Optical Coherence Tomography OCT allow a precise evaluation of the coronary plaque and can be extremely useful for monitoring plaque modifications obtained with thrombus aspiration TA Plaque burden will be assessed as plaque media PM commonly measured with IVUS by subtracting lumen L to external elastic membrane EEM cross sectional area PM EEM-L
Expecting a mean plaque volume of 16050 mm3 in a population of patients with ACS undergoing PCI a sample size of at least 45 patients 52 lesions with a recent 15 days but after 24 hours STEMI or a non-ST elevation NSTE-ACS within 72 hours of symptoms would provide a 90 power to detect a 20 reduction in the plaque volume after TA with an alpha probability value of 005
Expecting a mean plaque volume of 16050 mm3 in a population of patients with ACS undergoing PCI a sample size of at least 45 patients 52 lesions with a recent 15 days but after 24 hours STEMI or a non-ST elevation NSTE-ACS within 72 hours of symptoms would provide a 90 power to detect a 20 reduction in the plaque volume after TA with an alpha probability value of 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None