Intracranial AneurysmsNCT01949779
TransForm™ Occlusion Balloon Catheter Registry
An observational study of Intracranial Aneurysms, run by Stryker Neurovascular at 7 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- TransForm™ Occlusion Balloon Catheter
- Type of treatment
- Medical device
- How many people
- 81 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2013to Jan 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care/hospitals
Who may be able to join
- 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.
Who cannot join
- Subject's anatomy precludes safe delivery of the TransForm Occlusion Balloon Catheter.
- Subject's pregnant
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Central Baptist Hospital
Lexington, Kentucky, 40503
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
West Virginia University
Morgantown, West Virginia, 26505
Desert Regional Medical Center
Palm Springs, California, 92262
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
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
Read the detailed description
- 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.
- Up to 140 subjects will be enrolled at up to 15 study sites. A given site will be allowed to enroll a maximum of 20 subjects.
- Enrollment in the registry occurs after a signed Informed Consent Form has been obtained, and the index procedure starts.
- Conditions
- Intracranial Aneurysms
- Being tested
- TransForm™ Occlusion Balloon Catheter
- Keywords
- Coil embolization, TransForm™ Occlusion Balloon Catheter, Registry, Neurointerventional procedures
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransForm™ Occlusion Balloon CatheterDevice
TransForm™ Occlusion Balloon Catheter
| Study group | Role | What they receive |
|---|---|---|
| TransForm™ Occlusion Balloon Catheter | TransForm™ Occlusion Balloon Catheter Receives: Device: TransForm™ Occlusion Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheters Visualized That Reached Intended Target
The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization.
Measured: intra-procedure
Secondary outcomes (2)
Angiographic Assessment on Catheter
Visibility of TransForm™ OBC on angiography
Measured: intra-procedure
Procedural Technical Success
Ability of TransForm™ OBC to Perform as Intended
Measured: post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949779
- Sponsor's protocol ID
- T4023
- Status last verified
- Aug 2019
- First submitted
- 20 Sep 2013
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TransForm™ Occlusion Balloon Catheter Registry
- ClinicalTrials.gov ID
- NCT01949779
- Acronym / sponsor ID
- T4023
- Conditions
- Intracranial Aneurysms
- Keywords
- Coil embolization, TransForm™ Occlusion Balloon Catheter, Registry, Neurointerventional procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 25 Sep 2013 (estimated)
- Results
- Posted 19 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- 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.
- Up to 140 subjects will be enrolled at up to 15 study sites. A given site will be allowed to enroll a maximum of 20 subjects.
- Enrollment in the registry occurs after a signed Informed Consent Form has been obtained, and the index procedure starts.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TransForm™ Occlusion Balloon Catheter | – | Device: TransForm™ Occlusion Balloon CatheterTransForm™ Occlusion Balloon Catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care/hospitals
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Subject's anatomy precludes safe delivery of the TransForm Occlusion Balloon Catheter.
- Subject's pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TransForm™ Occlusion Balloon CatheterTransForm™ Occlusion Balloon Catheter | Device | TransForm™ Occlusion Balloon Catheter |
Primary outcome
Catheters Visualized That Reached Intended Target
Time frame: intra-procedure
The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization.
2 secondary outcomes
Angiographic Assessment on Catheter
Time frame: intra-procedure
Procedural Technical Success
Time frame: post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysms, run by Stryker Neurovascular at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheters Visualized That Reached Intended Target (time frame: intra-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.