Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04547387
Status:
UNKNOWN
Last Update Posted:
2021-01-06
First Post:
2020-08-31
Brief Title:
TCAR Cerebral Protection And MicroNET-Covered Stent To Reduce Strokes
Sponsor:
John Paul II Hospital Krakow
Organization:
John Paul II Hospital Krakow
Study Overview
Official Title:
Carotid Artery Revascularization Using TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System to Reduce Strokes in Patients With Symptoms or Signs of Cerebral Ischemia TOP-GUARD Study
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
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:
TOP-GUARD
Brief Summary:
Prospective single center clinical study in consecutive patients with symptoms or signs of carotid stenosis related ischemic cerebral injury undergoing carotid revascularization in primary and secondary stroke prevention MicroNET-covered stent is implanted using direct carotid artery access and temporary flow reversal to combine optimal intraprocedural cerebral protection and optimal plaque exclusion
Detailed Description:
Prospective single-center clinical study in consecutive patients undergoing carotid revascularization with MicroNET-covered stent implanted through direct carotid artery access with temporary intraprocedural flow reversal neuroprotection to provide primary and secondary stroke prevention
It is an open-label non-randomized single-arm study supported by the grant from Jagiellonian University Medical college KZDS007819
Stroke is a major health problem affecting individual patients and their families and entire societies with death and disability impact fundamental disability cause in Poland Europe and the USA Atherosclerotic carotid artery stenosis plays an important part in a stroke etiology through embolic andor hemodynamic mechanism
Endovascular treatment with first-generation carotid stents is inherently related to plaque and thrombus prolapse through stent struts as confirmed with the intravascular imaging IVUS and OCT and monitoring of cerebral embolism by DW-MRI Plaque prolapse related embolism may occur after neuroprotection device removal Postprocedural plaque-prolapse related ischemic events are responsible for 40-60 complications up to 30 days as indicated by 30-day results of large clinical trials CAPTURE CREST or ICSS
A successful attempt to address this problem has been an introduction and routine use of MicroNET-covered stent The MicroNET attached to the metallic stent prevents intraluminal plaque prolapse MRI imaging indicated a significant reduction of intraprocedural embolism and near-elimination of post-procedural brain embolism by CGuard application Clinical research and meta-analysis of studies confirmed the safety and efficacy of the stent Consistent results were demonstrated in registries such as PARADIGM
Another critical approach in increasing the safety of the endovascular route of carotid revascularization is development and increased clinical uptake of minimally invasive endovascular strategies is the direct common carotid artery access for stenting procedures This way one can avoid femoral cannulation and navigation through the aorta and aortic arch branches Trans-Carotid Arterial Revascularization TCAR offers a neuroprotection mechanism by a temporary reversal of the cerebral flow similar to MoMa Ultra or GORE Flow Reversal systems but without limitations of femoral access and aortic arch cannulation TCAR system was CE marked in 2014 and more than 20 000 TCAR procedures were performed worldwide A recent analysis by Yee et al demonstrated that TCAR carotid stenting procedures are equivalent to surgical endarterectomy regarding safety and efficacy but with lower invasiveness avoiding the aortic arch and its cannulation-related cerebral embolism and shortened procedure time
According to published studies and our own experience proximal neuroprotection and in particular the one achieved through direct carotid artery access minimizes cerebral microembolization risk
Our prospective TOP-GUARD study aims to evaluate early- mid- and longterm outcome data up to 5 years on the results of carotid revascularization combining two systems that are currently considered safest temporary cerebral flow-reversal during stent introduction via direct carotid artery access and MicroNET-covered stent implantation
Both systems are CE-marked from 2014 have been successfully used in our center and will follow their on-label indications
The TCAR system from SilkRoad Medical EnRoute is the preferred method to obtain flow reversal for transcervical CAS in the study However due to interruption of the EnRoute system supplies COVID19 SARS-CoV-2 Pandemic routinely available sheaths catheters and blood filters may be used according to literature to assemble the flow reversal circuit enabling continuation of the study as per the Ethical Committee updated approval
Consecutive patients with symptoms or signs of cerebral ischemia ie patients with an increased risk of complications when conventional carotid stents and neuroprotection systems are used will undergo NeuroVascular Team neurologist interventionalist and vascular surgeon evaluation for their eligibility They will be treated according to the center standard of care including necessary peri- and postprocedural medication
MRI cerebral imaging will be performed at baseline 24-48 hours post-procedurally and at 90 days in 50 of study participants
It is an open-label non-randomized single-arm study supported by the grant from Jagiellonian University Medical college KZDS007819
Stroke is a major health problem affecting individual patients and their families and entire societies with death and disability impact fundamental disability cause in Poland Europe and the USA Atherosclerotic carotid artery stenosis plays an important part in a stroke etiology through embolic andor hemodynamic mechanism
Endovascular treatment with first-generation carotid stents is inherently related to plaque and thrombus prolapse through stent struts as confirmed with the intravascular imaging IVUS and OCT and monitoring of cerebral embolism by DW-MRI Plaque prolapse related embolism may occur after neuroprotection device removal Postprocedural plaque-prolapse related ischemic events are responsible for 40-60 complications up to 30 days as indicated by 30-day results of large clinical trials CAPTURE CREST or ICSS
A successful attempt to address this problem has been an introduction and routine use of MicroNET-covered stent The MicroNET attached to the metallic stent prevents intraluminal plaque prolapse MRI imaging indicated a significant reduction of intraprocedural embolism and near-elimination of post-procedural brain embolism by CGuard application Clinical research and meta-analysis of studies confirmed the safety and efficacy of the stent Consistent results were demonstrated in registries such as PARADIGM
Another critical approach in increasing the safety of the endovascular route of carotid revascularization is development and increased clinical uptake of minimally invasive endovascular strategies is the direct common carotid artery access for stenting procedures This way one can avoid femoral cannulation and navigation through the aorta and aortic arch branches Trans-Carotid Arterial Revascularization TCAR offers a neuroprotection mechanism by a temporary reversal of the cerebral flow similar to MoMa Ultra or GORE Flow Reversal systems but without limitations of femoral access and aortic arch cannulation TCAR system was CE marked in 2014 and more than 20 000 TCAR procedures were performed worldwide A recent analysis by Yee et al demonstrated that TCAR carotid stenting procedures are equivalent to surgical endarterectomy regarding safety and efficacy but with lower invasiveness avoiding the aortic arch and its cannulation-related cerebral embolism and shortened procedure time
According to published studies and our own experience proximal neuroprotection and in particular the one achieved through direct carotid artery access minimizes cerebral microembolization risk
Our prospective TOP-GUARD study aims to evaluate early- mid- and longterm outcome data up to 5 years on the results of carotid revascularization combining two systems that are currently considered safest temporary cerebral flow-reversal during stent introduction via direct carotid artery access and MicroNET-covered stent implantation
Both systems are CE-marked from 2014 have been successfully used in our center and will follow their on-label indications
The TCAR system from SilkRoad Medical EnRoute is the preferred method to obtain flow reversal for transcervical CAS in the study However due to interruption of the EnRoute system supplies COVID19 SARS-CoV-2 Pandemic routinely available sheaths catheters and blood filters may be used according to literature to assemble the flow reversal circuit enabling continuation of the study as per the Ethical Committee updated approval
Consecutive patients with symptoms or signs of cerebral ischemia ie patients with an increased risk of complications when conventional carotid stents and neuroprotection systems are used will undergo NeuroVascular Team neurologist interventionalist and vascular surgeon evaluation for their eligibility They will be treated according to the center standard of care including necessary peri- and postprocedural medication
MRI cerebral imaging will be performed at baseline 24-48 hours post-procedurally and at 90 days in 50 of study participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None