Intracranial AneurysmPropackINCT02292017
Prospective Packing Density With Target Coils I
A study testing Embolization of intracranial aneurysm in people with Intracranial Aneurysm, run by Tennessee Neurovascular Institute, LLC at 1 site in United States.
Trial summary
This is a prospective single center trial investigating the effects of prospectively measuring packing density prior to choosing Target Coils for the treatment of intracranial saccular aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Embolization of intracranial aneurysm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 1 Aug 2019
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is between 18 and 85 years of age (inclusive).
- Patient has a documented untreated intracranial saccular aneurysm 4-20 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils.
- Target® Coils are considered a treatment option. Every attempt should be made to treat with Target coils as possible to achieve optimal occlusion.
- Target aneurysm can be adequately coiled at index procedure (NO staged coiling procedures).
- Target aneurysm morphology allows for adequate retention of coils within the aneurysmal sac without occlusion of the parent artery, as determined by the treating physician.
- Patient or patient's legally authorized representative has provided written informed consent.
- Patient is willing and able to comply with protocol follow-up requirements.
Who cannot join
- Candidates must be excluded from the study if ANY of the following criteria are met at the time of screening:
- Patient is <18 or >80 years old.
- Target aneurysm is not saccular in nature (mycotic, fusiform, and dissecting).
- Target aneurysm is >20 mm maximum luminal dimension, <4 mm maximum luminal dimension.
- Target aneurysm has been previously treated by surgery or endovascular therapy.
- Target aneurysm is in the physician's estimation unlikely to be successfully treated by endovascular techniques.
Show all 16Show fewer
- Patient presents as Hunt and Hess grade IV or V for a ruptured aneurysm.
- Patient presents with Modified Rankin Score 4 or 5 at baseline.
- Patient is concurrently enrolled in another investigational drug or device study unless the sponsor grants permission.
- Patient has known hypersensitivity to platinum, nickel, stainless steel or structurally related compounds found in Target® Coils.
- Patients who have had or could have a severe reaction to contrast agents that cannot be adequately pre-medicated prior to the coiling procedure.
- Patients who are unable to complete scheduled follow up assessments at the enrolling center due to limited life expectancy (<12 months), comorbidities or geographical considerations.
- Planned use of adjunctive therapy stents except Neuroform is not allowed.
- Patients with Moya-Moya disease, AVMs, arteriovenous fistula, intracranial tumors, intracranial hematoma (unrelated to target aneurysm), significant atherosclerotic stenosis, tortuosity or other conditions preventing access to the target aneurysm.
- 15. Target aneurysm with significant thrombosis that may increase the likelihood of recanalization at the discretion on the investigator.
- 16. Female patient has a positive pregnancy assessment at baseline.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916
About this study
Official title: A Prospective Single Center Trial Investigating the Effects of Prospectively Measuring Packing Density Prior to Choosing Target Coils for the Treatment of Intracranial Saccular Aneurysms.
This is a prospective single center trial investigating the effects of prospectively measuring packing density prior to choosing Target Coils for the treatment of intracranial saccular aneurysms. Up to 25 eligible subjects with ruptured or unruptured intracranial saccular aneurysms between 4-20mm (maximum dimension), who consent to study participation, will be treated with Stryker Target Detachable Coils.
Historical data from patients enrolled in the MAPS trial at the single center will be the control arm of the trial and reviewed for comparison to the prospective arm. In the control arm, the subjects received Stryker Matrix2 Detachable Coils and Guglielmi Detachable Coils and packing density was not measured prior to these procedures. The Pro-Pack Trial will evaluate the outcomes of the subjects treated with Target Coils, in whom the packing density will be actively calculated prior to coil selection. This will serve to establish that a higher packing density can be obtained by the change in methodology of coil selection and a higher packing density with lower recurrence rates.
Read the detailed description
The Pro Pack Trial will evaluate the outcomes of subjects treated with Target Coils, in whom the packing density is actively calculated prior to coil selection. Selecting the coil with the best volumetric filling has been shown to increase overall packing density. Each coil thereafter will be evaluated prior to placement to assess the resultant packing density. An initial goal of 10% or greater packing density with the first coil will be used as a guide to coil selection. A final packing density of greater than 25% should be attempted as feasible. Currently, a maximum packing density is not defined. While theoretically a packing density may approach 100%, in reality the spaces between the coil loops occupy a large percentage of the coil mass, and packing densities rarely reach 50% or greater. As such, the final packing density is left to the operator, and is based on ability to place coils safely by the operator.
Potential subjects will be screened, consented, imaged, and evaluated in order to obtain 25 patients with complete 12-month follow-up. Baseline patient data will be collected at the time of the procedure; follow-up information will be collected within 48 hours of the procedure, and at approximately 12 months (±3 months) after the procedure. The anticipated study duration is approximately 24 months: 12 month recruitment, 12 month primary endpoint and closeout.
Enrollment in the study occurs after a signed Informed Consent form has been obtained, all eligibility criteria have been met, aneurysm volume has been calculated, and the procedure to place Target Coils with prospective density measurements has begun, i.e., at the time of target procedural angiography. From the moment of placement of the first coil, the patient is considered in the study whether they receive Target Coils or not, and will be followed up and included in the final analysis. Patients enrolled in the trial will be followed for approximately 12 months after the index embolization procedure. This will allow evaluation of the primary and secondary study endpoints. Targeted enrollment is 25 patients with complete 12 month follow-up evaluations. Every effort will be made to follow the progress and monitor the safety of patients who have been treated with Target® Coils.
Embolization utilizing Target® Coils may proceed at the time of diagnostic angiography for eligible patients who have signed an Informed Consent form. The investigator must perform the embolization procedure. Framing, filling, and finishing should be done with Target Coils. In the event of aneurysms with wide necks or unfavorable anatomy, adjunctive therapy, Neuroform Stent may be used to ensure the best clinical and angiographic results.
The site will enter ongoing, real time information into an electronic imaging database and track outcomes during the follow-up angiographic evaluations. The degree of occlusion, by coils and/or thrombus, will be measured post procedurally and at 12 +/- 3 months post procedure by the Angiographic Core Laboratory using a 3 point categorical scale: complete, residual neck/dog ear or residual aneurysm. Additionally, for the final angiogram, a same/ better / worse scale shall be applied.
- Conditions
- Intracranial Aneurysm
- Being tested
- Embolization of intracranial aneurysm
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embolization of intracranial aneurysmDevice
Also called Coiling procedure
Cerebral angiogram will be performed, target aneurysm measurements are performed including dome height, width, and depth as well as the neck length. Aneurysm volume will be calculated. During the embolization, framing, filling, and finishing should be done with Target Coils. In the event of aneurysms with a wide neck a Neuroform Stent may be used to ensure the best clinical and angiographic outcome. Immediate post procedure angiography is performed using the same pre-treatment views to assess results and complications.
| Study group | Role | What they receive |
|---|---|---|
| Embolization of intracranial aneurysm | Experimental | Embolization with Target Coils Receives: Device: Embolization of intracranial aneurysm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Packing density
Increased packing density defined as an relative increase by 20% compared to the control arm after initial treatment.
Measured: 24 hours
Secondary outcomes (4)
Target Aneurysm Recurrence (TAR)
Angiographic assessments performed at 12-15 months consisting of residual aneurysm (Modified Raymond Scale) Complete, residual neck, or residual aneurysm.
Measured: Up to 15 months
Change of aneurysm filling
Same Better Worse Scale: The percentage of patients who experience any increase/decrease or no change of the aneurysm filling compared to initial post-treatment angiogram.
Measured: 12-15 months
Technical Procedure Success
Successful delivery and deployment of Target coils in the target aneurysm without intraoperative rupture.
Measured: 24 hours
Neurological morbidity/mortality
Measure functional outcomes by modified Rankin Scale
Measured: 12-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startOct 2014
- Primary completion1 Feb 2018
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tennessee Neurovascular Institute, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Woodward, MD, Principal investigator, Tennessee Neurovascular Institute, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292017
- Sponsor's protocol ID
- TNVI 001
- Acronym
- PropackI
- Status last verified
- Sep 2018
- First submitted
- 12 Nov 2014
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Center Trial Investigating the Effects of Prospectively Measuring Packing Density Prior to Choosing Target Coils for the Treatment of Intracranial Saccular Aneurysms.
- ClinicalTrials.gov ID
- NCT02292017
- Acronym / sponsor ID
- PropackI / TNVI 001
- Conditions
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tennessee Neurovascular Institute, LLCUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 17 Nov 2014 (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.
This is a prospective single center trial investigating the effects of prospectively measuring packing density prior to choosing Target Coils for the treatment of intracranial saccular aneurysms. Up to 25 eligible subjects with ruptured or unruptured intracranial saccular aneurysms between 4-20mm (maximum dimension), who consent to study participation, will be treated with Stryker Target Detachable Coils.
Historical data from patients enrolled in the MAPS trial at the single center will be the control arm of the trial and reviewed for comparison to the prospective arm. In the control arm, the subjects received Stryker Matrix2 Detachable Coils and Guglielmi Detachable Coils and packing density was not measured prior to these procedures. The Pro-Pack Trial will evaluate the outcomes of the subjects treated with Target Coils, in whom the packing density will be actively calculated prior to coil selection. This will serve to establish that a higher packing density can be obtained by the change in methodology of coil selection and a higher packing density with lower recurrence rates.
Detailed description
The Pro Pack Trial will evaluate the outcomes of subjects treated with Target Coils, in whom the packing density is actively calculated prior to coil selection. Selecting the coil with the best volumetric filling has been shown to increase overall packing density. Each coil thereafter will be evaluated prior to placement to assess the resultant packing density. An initial goal of 10% or greater packing density with the first coil will be used as a guide to coil selection. A final packing density of greater than 25% should be attempted as feasible. Currently, a maximum packing density is not defined. While theoretically a packing density may approach 100%, in reality the spaces between the coil loops occupy a large percentage of the coil mass, and packing densities rarely reach 50% or greater. As such, the final packing density is left to the operator, and is based on ability to place coils safely by the operator.
Potential subjects will be screened, consented, imaged, and evaluated in order to obtain 25 patients with complete 12-month follow-up. Baseline patient data will be collected at the time of the procedure; follow-up information will be collected within 48 hours of the procedure, and at approximately 12 months (±3 months) after the procedure. The anticipated study duration is approximately 24 months: 12 month recruitment, 12 month primary endpoint and closeout.
Enrollment in the study occurs after a signed Informed Consent form has been obtained, all eligibility criteria have been met, aneurysm volume has been calculated, and the procedure to place Target Coils with prospective density measurements has begun, i.e., at the time of target procedural angiography. From the moment of placement of the first coil, the patient is considered in the study whether they receive Target Coils or not, and will be followed up and included in the final analysis. Patients enrolled in the trial will be followed for approximately 12 months after the index embolization procedure. This will allow evaluation of the primary and secondary study endpoints. Targeted enrollment is 25 patients with complete 12 month follow-up evaluations. Every effort will be made to follow the progress and monitor the safety of patients who have been treated with Target® Coils.
Embolization utilizing Target® Coils may proceed at the time of diagnostic angiography for eligible patients who have signed an Informed Consent form. The investigator must perform the embolization procedure. Framing, filling, and finishing should be done with Target Coils. In the event of aneurysms with wide necks or unfavorable anatomy, adjunctive therapy, Neuroform Stent may be used to ensure the best clinical and angiographic results.
The site will enter ongoing, real time information into an electronic imaging database and track outcomes during the follow-up angiographic evaluations. The degree of occlusion, by coils and/or thrombus, will be measured post procedurally and at 12 +/- 3 months post procedure by the Angiographic Core Laboratory using a 3 point categorical scale: complete, residual neck/dog ear or residual aneurysm. Additionally, for the final angiogram, a same/ better / worse scale shall be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embolization of intracranial aneurysm | Experimental | Device: Embolization of intracranial aneurysmEmbolization with Target Coils |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is between 18 and 85 years of age (inclusive).
- Patient has a documented untreated intracranial saccular aneurysm 4-20 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils.
- Target® Coils are considered a treatment option. Every attempt should be made to treat with Target coils as possible to achieve optimal occlusion.
- Target aneurysm can be adequately coiled at index procedure (NO staged coiling procedures).
- Target aneurysm morphology allows for adequate retention of coils within the aneurysmal sac without occlusion of the parent artery, as determined by the treating physician.
Key exclusion criteria (16 listed)
- Candidates must be excluded from the study if ANY of the following criteria are met at the time of screening:
- Patient is <18 or >80 years old.
- Target aneurysm is not saccular in nature (mycotic, fusiform, and dissecting).
- Target aneurysm is >20 mm maximum luminal dimension, <4 mm maximum luminal dimension.
- Target aneurysm has been previously treated by surgery or endovascular therapy.
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 |
|---|---|---|
| Embolization of intracranial aneurysmAlso: Coiling procedureCerebral angiogram will be performed, target aneurysm measurements are performed including dome height, width, and depth as well as the neck length. Aneurysm volume will be calculated. During the embolization, framing, filling, and finishing should be done with Target Coils. In the event of aneurysms with a wide neck a Neuroform Stent may be used to ensure the best clinical and angiographic outcome. Immediate post procedure angiography is performed using the same pre-treatment views to assess results and complications. | Device | Embolization of intracranial aneurysm |
Primary outcome
Packing density
Time frame: 24 hours
Increased packing density defined as an relative increase by 20% compared to the control arm after initial treatment.
4 secondary outcomes
Target Aneurysm Recurrence (TAR)
Time frame: Up to 15 months
Change of aneurysm filling
Time frame: 12-15 months
Technical Procedure Success
Time frame: 24 hours
Neurological morbidity/mortality
Time frame: 12-15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
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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.
Keith Woodward, MD principal investigator
Tennessee Neurovascular Institute, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embolization of intracranial aneurysm in people with Intracranial Aneurysm, run by Tennessee Neurovascular Institute, LLC at 1 site in United States.
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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 11 Sep 2018. 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 United States. 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?
Results are not available in the source record.
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?
Packing density (time frame: 24 hours). 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 11 Sep 2018.