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The purpose of this clinical trial is to study the two main types of approaches used in stroke thrombectomy and to investigate if one approach is more effective than the other, as this is currently not known. This study will be conducted in adults who have been diagnosed with an acute ischemic stroke and who are undergoing a thrombectomy for the treatment of their stroke. The main questions it aims to answer are:
Participants will be asked to
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon Guide Catheter | Other | Use of a balloon guide catheter in stroke thrombectomy. |
|
| Conventional Guide Catheter | Other | Use of conventional (non-balloon guide) catheter in stroke thrombectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of a Balloon Guide Catheter | Other | Use of a balloon guide catheter in stroke thrombectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| TICI Grading Scale Score | Use of a mTICI grading scale to look at the degree to which the vessel has been opened during a mechanical thrombectomy. | Participant duration is 90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Outcomes | Metrics associated with a standard of care thrombectomy procedure, such as length of procedure, will be collected. | Participant duration is 90 days. |
| Number of Participants with Treatment Related Adverse Effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida (USF) | Recruiting | Tampa | Florida | 33606 | United States |
IPD will not be shared with participants as both catheters are routinely used in acute ischemic stroke thrombectomy. The decision to use a balloon guide versus a conventional guide catheter is usually left to the discretion of the operator.
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Use of a Conventional (non-balloon) Guide Catheter | Other | Use of a conventional (non-balloon) guide catheter in stroke thrombectomy. |
|
Collection of data related to clincial and safety outcomes such as presence of a bleed.
| Participant duration is 90 days. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |