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The primary objective of this registry is to collect real world data on the safety and performance of the TransForm™ Occlusion Balloon Catheter when used in current neurointerventional procedures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TransForm™ Occlusion Balloon Catheter | TransForm™ Occlusion Balloon Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TransForm™ Occlusion Balloon Catheter | Device | TransForm™ Occlusion Balloon Catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Catheters Visualized That Reached Intended Target | The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization. | intra-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic Assessment on Catheter | Visibility of TransForm™ OBC on angiography | intra-procedure |
| Procedural Technical Success | Ability of TransForm™ OBC to Perform as Intended |
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Inclusion Criteria:
Exclusion Criteria:
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primary care/hospitals
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Regional Medical Center | Palm Springs | California | 92262 | United States | ||
| Central Baptist Hospital |
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Enrollment occurred over 13 months at 7 sites in the US and 1 site in Spain. Each site was allowed to enroll up to 20 consecutive subjects. The first subject was enrolled on 12 December 2013 and the enrollment was completed on 12 January 2015. A total of 81 subjects were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | TransForm OBC | TransForm Occlusion Balloon Catheter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TransForm OBC | TransForm Occlusion Balloon Catheter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Catheters Visualized That Reached Intended Target | The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization. | The number of catheters exceeds the number of participants enrolled, as more than one catheter may have been used for each participant. | Posted | Mean | Standard Deviation | Catheters | intra-procedure | Catheters | Catheters |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TransForm OBC | TransForm Occlusion Balloon Catheter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboembolic event | Injury, poisoning and procedural complications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombus formation | Surgical and medical procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheryl Fontana, Sr. Manager, Clinical Services | Stryker Neurovascular | 510-413-2948 | cheryl.fontana1@stryker.com |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| post-procedure |
| Lexington |
| Kentucky |
| 40503 |
| United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| West Virginia University | Morgantown | West Virginia | 26505 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Hospital Universitario Donostia | Donostia / San Sebastian | Spain |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Catheters |
|
|
| Secondary | Angiographic Assessment on Catheter | Visibility of TransForm™ OBC on angiography | Posted | Mean | Standard Deviation | Catheters | intra-procedure | Catheters | Catheters |
|
|
|
| Secondary | Procedural Technical Success | Ability of TransForm™ OBC to Perform as Intended | Posted | Number | Catheters | post-procedure |
|
|
|
| 3 |
| 81 |
| 2 |
| 81 |
| Vessel rupture/perforation | Surgical and medical procedures |
|
| Thrombus formation | Injury, poisoning and procedural complications |
|
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |