N/A
Completed N=81
TransForm™ Occlusion Balloon Catheter Registry
Source: ClinicalTrials.gov NCT01949779 ↗Enrolled (actual)
81
Serious AEs
3.7%
Results posted
Aug 2019
Primary outcomePrimary: Catheters Visualized That Reached Intended Target — 1.59 Catheters
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
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 | — |
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. Informational only — not medical advice.