Aortic Aneurysm, AbdominalPhase 1NCT00355940
Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures
A Phase 1 study testing Technological Methods and Regular Fluoroscopy in people with Aortic Aneurysm, Abdominal, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The investigators want to test a navigation system for guidance during insertion of stent graft in abdominal aortic aneurysms. The navigation system consists of software developed by SINTEF Health, a custom made catheter with a micro position sensor in the tip and an emitter than induces an electromagnetic field… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Technological Methods and Regular Fluoroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2007to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AAA with diameter > 5,0 cm suitable for endovascular technique
- Normal creatinine
- > 60 years of age
Who cannot join
- Known heart failure or unstable coronary disease
- Other morbidity than normally contraindicates endovascular treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures Traditional Fluoroscopy Navigation Based on Preoperative CT and Intraoperative DynaCT
The investigators want to test a navigation system for guidance during insertion of stent graft in abdominal aortic aneurysms. The navigation system consists of software developed by SINTEF Health, a custom made catheter with a micro position sensor in the tip and an emitter than induces an electromagnetic field around the patient. Preoperative CT- and intraoperative DynaCT- data are reconstructed into 3 dimensional images. The 3 dimensional images are loaded into the navigation system. Then the magnetic field, in which the patient finds himself, is calibrated with the 3 dimensional images. When the catheter is inserted into the iliac artery and aorta, the position sensor (in the tip of the catheter) is displayed in real time at the exact anatomic location in the 3 dimensional image.
Null hypothesis (H0):
Read more
- Insertion of stent graft is performed equally satisfactorily with fluoroscopy alone as with both fluoroscopy and new navigation technology
Alternative hypothesis (H2):
- Insertion of stent graft is NOT performed equally satisfactorily with fluoroscopy alone as with both fluoroscopy and new navigation technology
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Technological Methods, Regular Fluoroscopy
- Keywords
- endovascular, aortic, repair, navigation, DynaCT, position, sensor
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technological MethodsDevice
Also called Custom made devices in addition to Siemens angiography suite
Usage of technological methods and devices to improve intravascular navigation during endovascular aortic repair.
In this arm we first use an optical pointer to allocate the femoral artery ramification (point of incision) and the lower renal artery (upper confinement of stent graft). Later we use an electromagnetically tracked catheter to find and enter the opening in the main stent graft before placing the second limb. For both optical and electromagnetic tracking we use a custom made navigation system based on 3 dimensional CT images
Regular FluoroscopyDevice
Also called Siemens angiography suite
Usage of conventional fluoroscopy and angiography for intravascular navigation. In this arm standard endovascular aortic repair is performed. The only means of navigation are fluoroscopy and angiography with overlay function (standard).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Technological Methods |
| 2 | Active comparator | Not described Receives: Device: Regular Fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure time (s) for defining renal branch
Measured: No time frame
Measure time (s) for inserting guidewire into "second limb"
Measured: 900 sec
Number of attempts for inserting guidewire into "second limb"
Measured: 900 sec
Measure total time (min) for entire procedure
Measured: No time frame
Measure the total of x-ray dose (mGy/m2)
Measured: No time frame
Measure the total of contrast fluid used (ml)
Measured: No time frame
Define type I leak between stent graft and aortic wall
Measured: No time frame
Measure distance (mm) between stent graft and renal arteries
Measured: No time frame
Measure difference (mm) in actual position and position in 3D image when pointing at the femoral division with an optic pointer
Measured: No time frame
Measure difference (mm) of the position of the renal arteries defined by optical pointer and angiography (both marked extracorporal with a needle)
Measured: No time frame
Secondary outcomes (3)
1 questionnaire: "Can 3D image and navigation technology simplify and secure endovascular procedures?"
Measured: No time frame
2 questionnaire: "Do you believe in further development of this technology?"
Measured: No time frame
3 questionnaire: "Have both renal arteries unaltered flow?"
Measured: No time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startAug 2007
- Primary completionJan 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, AbdominalStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- SINTEF Health Research, St. Olavs Hospital, The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Frode Manstad-Hulaas, MD, Principal investigator, Norwegian University of Science and TechnologyPetter Aadahl, Professor, Study director, Norwegian University of Science and TechnologyToril N Hernes, Professor, Study director, SINTEF Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355940
- Sponsor's protocol ID
- STO-NTNU/DMF-SINTEF-1
- Status last verified
- Apr 2013
- First submitted
- 24 Jul 2006
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Manstad-Hulaas F, Tangen GA, Dahl T, Hernes TA, Aadahl P. Three-dimensional electromagnetic navigation vs. fluoroscopy for endovascular aneurysm repair: a prospective feasibility study in patients. J Endovasc Ther. 2012 Feb;19(1):70-8. doi: 10.1583/11-3557.1.
PubMed 22313205
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures Traditional Fluoroscopy Navigation Based on Preoperative CT and Intraoperative DynaCT
- ClinicalTrials.gov ID
- NCT00355940
- Acronym / sponsor ID
- STO-NTNU/DMF-SINTEF-1
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- endovascular, aortic, repair, navigation, DynaCT, position, sensor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- SINTEF Health Research, St. Olavs Hospital, The Research Council of Norway
- Study start
- Aug 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 25 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators want to test a navigation system for guidance during insertion of stent graft in abdominal aortic aneurysms. The navigation system consists of software developed by SINTEF Health, a custom made catheter with a micro position sensor in the tip and an emitter than induces an electromagnetic field around the patient. Preoperative CT- and intraoperative DynaCT- data are reconstructed into 3 dimensional images. The 3 dimensional images are loaded into the navigation system. Then the magnetic field, in which the patient finds himself, is calibrated with the 3 dimensional images. When the catheter is inserted into the iliac artery and aorta, the position sensor (in the tip of the catheter) is displayed in real time at the exact anatomic location in the 3 dimensional image.
Null hypothesis (H0):
- Insertion of stent graft is performed equally satisfactorily with fluoroscopy alone as with both fluoroscopy and new navigation technology
Alternative hypothesis (H2):
- Insertion of stent graft is NOT performed equally satisfactorily with fluoroscopy alone as with both fluoroscopy and new navigation technology
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Technological Methods |
| 2 | Active comparator | Device: Regular Fluoroscopy |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AAA with diameter > 5,0 cm suitable for endovascular technique
- Normal creatinine
- > 60 years of age
Key exclusion criteria (2 listed)
- Known heart failure or unstable coronary disease
- Other morbidity than normally contraindicates endovascular treatment
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 |
|---|---|---|
| Technological MethodsAlso: Custom made devices in addition to Siemens angiography suiteUsage of technological methods and devices to improve intravascular navigation during endovascular aortic repair. In this arm we first use an optical pointer to allocate the femoral artery ramification (point of incision) and the lower renal artery (upper confinement of stent graft). Later we use an electromagnetically tracked catheter to find and enter the opening in the main stent graft before placing the second limb. For both optical and electromagnetic tracking we use a custom made navigation system based on 3 dimensional CT images | Device | 1 |
| Regular FluoroscopyAlso: Siemens angiography suiteUsage of conventional fluoroscopy and angiography for intravascular navigation. In this arm standard endovascular aortic repair is performed. The only means of navigation are fluoroscopy and angiography with overlay function (standard). | Device | 2 |
Primary outcome
Measure time (s) for defining renal branch
Time frame: No time frame
Measure time (s) for inserting guidewire into "second limb"
Time frame: 900 sec
Number of attempts for inserting guidewire into "second limb"
Time frame: 900 sec
Measure total time (min) for entire procedure
Time frame: No time frame
Measure the total of x-ray dose (mGy/m2)
Time frame: No time frame
Measure the total of contrast fluid used (ml)
Time frame: No time frame
Define type I leak between stent graft and aortic wall
Time frame: No time frame
Measure distance (mm) between stent graft and renal arteries
Time frame: No time frame
Measure difference (mm) in actual position and position in 3D image when pointing at the femoral division with an optic pointer
Time frame: No time frame
Measure difference (mm) of the position of the renal arteries defined by optical pointer and angiography (both marked extracorporal with a needle)
Time frame: No time frame
3 secondary outcomes
1 questionnaire: "Can 3D image and navigation technology simplify and secure endovascular procedures?"
Time frame: No time frame
2 questionnaire: "Do you believe in further development of this technology?"
Time frame: No time frame
3 questionnaire: "Have both renal arteries unaltered flow?"
Time frame: No time frame
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2013.
- Results publication: PubMed 22313205Manstad-Hulaas F, Tangen GA, Dahl T, Hernes TA, Aadahl P. Three-dimensional electromagnetic navigation vs. fluoroscopy for endovascular aneurysm repair: a prospective feasibility study in patients. J Endovasc Ther. 2012 Feb;19(1):70-8. doi: 10.1583/11-3557.1.
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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.
Frode Manstad-Hulaas, MD principal investigator
Norwegian University of Science and Technology
Petter Aadahl, Professor study director
Norwegian University of Science and Technology
Toril N Hernes, Professor study director
SINTEF Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Technological Methods and Regular Fluoroscopy in people with Aortic Aneurysm, Abdominal, run by Norwegian University of Science and Technology at 1 site in Norway.
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 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure time (s) for defining renal branch (time frame: No time frame). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00355940, which also lists 1 linked publication.
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 29 Apr 2013.