N/A
N=81
TransForm™ Occlusion Balloon Catheter Registry
Intracranial Aneurysms
Bottom Line
View on ClinicalTrials.gov: NCT01949779 ↗Enrolled (actual)
81
Serious AEs
3.7%
Results posted
Aug 2019
Primary outcome: Primary: Catheters Visualized That Reached Intended Target — 1.59 Catheters
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- TransForm™ Occlusion Balloon Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stryker Neurovascular
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Catheters Visualized That Reached Intended Target |
1.59 | — |
| SECONDARY Angiographic Assessment on Catheter |
1.78 | — |
| SECONDARY Procedural Technical Success |
83 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- Subject or legal representative is willing and has provided informed consent.
- Subject is scheduled to undergo a neurointerventional procedure that may include the use of the occlusion balloon catheter.
- Subject is over 18 years of age.
Exclusion Criteria
- Subject's anatomy precludes safe delivery of the TransForm Occlusion Balloon Catheter.
- Subject's pregnant
Data sourced from ClinicalTrials.gov (NCT01949779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.