TransForm™ Occlusion Balloon Catheter Registry
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 2/7/2015 |
Start Date: | November 2013 |
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
performance of the TransForm™ Occlusion Balloon Catheter when used in current
neurointerventional procedures
- This is a prospective, single-arm, non-randomized, multi-center, observational
registry.
- The expected duration for study enrollment is approximately 6 months-1 year.
- Study participation for each subject will be completed upon removal of the guide
catheter post-procedure.
- Approximately 70 subjects will be enrolled at up to 7 study sites (approximately 5
sites in the United States and 2 sites internationally). Each site will be allowed to
enroll up to a maximum subject of 15 subjects per site.
- Enrollment in the registry occurs after a signed Informed Consent Form has been
obtained, and the index procedure starts.
registry.
- The expected duration for study enrollment is approximately 6 months-1 year.
- Study participation for each subject will be completed upon removal of the guide
catheter post-procedure.
- Approximately 70 subjects will be enrolled at up to 7 study sites (approximately 5
sites in the United States and 2 sites internationally). Each site will be allowed to
enroll up to a maximum subject of 15 subjects per site.
- Enrollment in the registry occurs after a signed Informed Consent Form has been
obtained, and the index procedure starts.
Inclusion Criteria:
1. Subject or legal representative is willing and has provided informed consent.
2. Subject is scheduled to undergo a neurointerventional procedure that may include the
use of the occlusion balloon catheter.
3. Subject is over 18 years of age.
Exclusion Criteria:
1. Subject's anatomy precludes safe delivery of the TransForm Occlusion Balloon
Catheter.
2. Subject's pregnant
We found this trial at
6
sites
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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