TransForm™ Occlusion Balloon Catheter Registry



Status:Recruiting
Healthy:No
Age Range:18 - 80
Updated:2/7/2015
Start Date:November 2013

Use our guide to learn which trials are right for you!

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

- 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.

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
55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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mi
from
Worcester, MA
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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mi
from
Columbus, OH
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1740 Nicholasville Rd
Lexington, Kentucky 40503
(859) 260-6100
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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mi
from
Lexington, KY
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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mi
from
Milwaukee, WI
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Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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mi
from
Morgantown, WV
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Palm Springs, California 92262
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mi
from
Palm Springs, CA
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