Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394180
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-26
Brief Title:
PeRforation EVents During ENdovascular Therapy for Acute Ischemic Stroke
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
PeRforation EVents During ENdovascular Therapy for Acute Ischemic Stroke PREVENT - Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
PREVENT
Brief Summary:
A large worldwide study called PREVENT is looking at a complication that can happen during a stroke treatment called thrombectomy This complication is a perforation of a blood vessel The investigators aim to
1 Find what factors make this perforation more likely
2 Understand why the perforation happens by looking closely at images taken during the procedure
3 Create a simple way to classify these perforations to help doctors decide how to treat them right away
4 Improve the emergent treatment of vessel perforation to stop the bleeding rapidly
5 Provide data to guide decision whether thrombectomy should be continued or aborted after the event of vessel perforation
6 Develop a safer way to perform thrombectomy
Investigators will compare the results collected for patients where perforation happened with those where perforation did not happen
1 Find what factors make this perforation more likely
2 Understand why the perforation happens by looking closely at images taken during the procedure
3 Create a simple way to classify these perforations to help doctors decide how to treat them right away
4 Improve the emergent treatment of vessel perforation to stop the bleeding rapidly
5 Provide data to guide decision whether thrombectomy should be continued or aborted after the event of vessel perforation
6 Develop a safer way to perform thrombectomy
Investigators will compare the results collected for patients where perforation happened with those where perforation did not happen
Detailed Description:
Stroke is the second leading cause of death and the leading cause of disability both worldwide and in Europe Endovascular treatment ENT also called thrombectomy is a minimally invasive procedure in which the occlusion of the brain-supplying artery which is the cause of the stroke is recanalized by removing the obstructing blood clot using endovascular methods ie via access through the vessels and thus restoring blood flow in the affected vessel and re-establishing brain perfusion In 2015 five randomized controlled trials showed an overwhelming benefit of thrombectomy in patients with acute ischemic stroke with large vessel occlusion of the anterior circulation with a number needed to treat as low as 26 Since then the indications for thrombectomy have been expanding continuously including patients with posterior circulation occlusions selected patients presenting late after symptom onset and patients with large infarcts In addition patients with distal vessel occlusions are increasingly being considered for thrombectomy
Despite the effectiveness of thrombectomy the procedure has a relevant risk of periprocedural complications In 1-2 of patients who undergo thrombectomy a periprocedural intracranial vessel perforation occurs with subsequent arterial intracranial bleeding This complication typically represents a major turning point and is associated with severe permanent sequelae and a mortality of approximately 50 Given the rapidly increasing frequency of thrombectomies an increase in the incidence of periprocedural perforations is to be expected The available data on vascular perforations during thrombectomy are limited It is unknown why a minority of patients experience this complication while the majority are spared Likewise the exact pathophysiological process that leads to vessel wall damage is not understood There is also uncertainty as to whether extravasation in the event of vessel perforation should be treated endovascularly with intention to stop the bleeding eg via temporary vessel occlusion using a balloon catheter or permanent vascular occlusion using coils or liquid embolization In addition there is hardly any data on whether thrombectomy attempts should continue after a perforation has occurred or whether the procedure should be aborted Due to the low frequency of this complication randomized prospective trials will most likely not be feasible
In an international retrospective cohort study with 25 participating centers the investigators were able to evaluate data from over 25000 thrombectomies In this cohort 335 vessel perforations were reported About half of the affected patients died within the first 3 months after perforation The remaining patients experienced a clinical course that was on average worse than that of stroke patients without perforation in large registries This research represents the largest cohort of patients with perforation during thrombectomy to date It shows that although perforations are rare complications they have enormous relevance for the affected patients
Despite the effectiveness of thrombectomy the procedure has a relevant risk of periprocedural complications In 1-2 of patients who undergo thrombectomy a periprocedural intracranial vessel perforation occurs with subsequent arterial intracranial bleeding This complication typically represents a major turning point and is associated with severe permanent sequelae and a mortality of approximately 50 Given the rapidly increasing frequency of thrombectomies an increase in the incidence of periprocedural perforations is to be expected The available data on vascular perforations during thrombectomy are limited It is unknown why a minority of patients experience this complication while the majority are spared Likewise the exact pathophysiological process that leads to vessel wall damage is not understood There is also uncertainty as to whether extravasation in the event of vessel perforation should be treated endovascularly with intention to stop the bleeding eg via temporary vessel occlusion using a balloon catheter or permanent vascular occlusion using coils or liquid embolization In addition there is hardly any data on whether thrombectomy attempts should continue after a perforation has occurred or whether the procedure should be aborted Due to the low frequency of this complication randomized prospective trials will most likely not be feasible
In an international retrospective cohort study with 25 participating centers the investigators were able to evaluate data from over 25000 thrombectomies In this cohort 335 vessel perforations were reported About half of the affected patients died within the first 3 months after perforation The remaining patients experienced a clinical course that was on average worse than that of stroke patients without perforation in large registries This research represents the largest cohort of patients with perforation during thrombectomy to date It shows that although perforations are rare complications they have enormous relevance for the affected patients
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