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Intracranial AneurysmSENATNCT00928265

Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

An observational study of Intracranial Aneurysm, run by Stryker Neurovascular at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective observational multicenter registry to evaluate safety and efficacy data on Neuroform3TM stenting for treatment with endovascular coiling of wide neck aneurysms on an intent to treat basis. The objectives of this study are: 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Aneurysm
What is being tested?
Endovascular treatment of intracranial aneurysm.
Type of treatment
Medical device
How many people
116 participants
Where
12 sitesFrance
Study dates
Jul 2008to Dec 2010
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient coming to the hospital to get an endovascular treatment of the aneurysm

Who may be able to join

  • 18 year's old patient or above.
  • every patient suffering from an un-ruptured or ruptured aneurysm, for whom the endovascular treatment approach using the Neuroform3TM stent is considered by the therapeutic team in charge.
  • patient who has given his consent to participate to the study and to get his anonymized data collected

Who cannot join

  • patient with dissecting or fusiform aneurysm
  • treatment of several aneurysms in the same procedure, except adjacent aneurysm treated by the same stent
  • severe vasospasm
  • aneurysm associated with an arterio-venous malformation
  • use of another Neuroform3TM stent
  • woman pregnant or nursing
Show all 9Show fewer
  • patients not likely to be followed upon (living abroad)
  • people protected by justice (safeguard of law, supervision or trusteeship)
  • patient unsuitable to the anti-thrombotic and/or to anticoagulants therapies

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • Centre Hospitalier pellegrin

    Bordeaux, 33076

  • CHU Hôpital de la Côte de Nacre

    Caen, 14033

  • CHRU Salengro

    Lille, 59037

  • CHU Limoges

    Limoges, 87042

  • Hôpital Neurologique

    Lyon, 69394

  • Hôpital Gui de Chauliac

    Montpellier, 34059

  • CHU Nancy

    Nancy, 54035

  • CHU Hôpital Guillaume et René Laënnec

    Nantes, 44035

  • Hôpital Saint-Roch

    Nice, 06000

  • Hôpital Lariboisière

    Paris, 75010

  • Groupe Hospitalier Pitié-Salpétrière

    Paris, 75013

  • Fondation Rotschild

    Paris, 75019

Other trials in France

About this study

This is a prospective observational multicenter registry to evaluate safety and efficacy data on Neuroform3TM stenting for treatment with endovascular coiling of wide neck aneurysms on an intent to treat basis.

The objectives of this study are:

  1. Assessment of morbidity-mortality at 1 month and 12-18 months following the treatment of the intracranial aneurysm with Neuroform3TM stent and endovascular coiling using the modified Rankin scale (mRS).
  2. to evaluate adverse events.
  3. Angiographic assessment at 12-18 months compared to the initial post-treatment assessment via the modified Raymond scale and same/better/worse scale.
Read the detailed description

There is an increasing perception in the Neurovascular community - supported by extensive peer-to-peer and congress communications - that "stent-assisted coiling" of intracranial wide neck aneurysms improves the long term angiographic outcome of treated patients.

Being tested
Endovascular treatment of intracranial aneurysm.
Keywords
intracranial, stenting, endovascular treatment, stent-assisted coiling, cerebrovascular disease
Medical subject headings
Intracranial Aneurysm, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovascular treatment of intracranial aneurysm.Device

    Also called Neuroform3TM Microdelivery Stent System, M003E3250100,M003E3250150,M003E3250200,, M003E3300100,M003E3300150,M003E3300200,M003E3300300, M003E3350100,M003E3350150,M003E3350200,M003E3350300

    Neuroform stent is used in conjunction of occlusives devices such as coils. Neuroform Stent allows the treatment of wide neck aneurysm with embolic coils. Put in front of the wide neck, it keeps the coils into the aneurysm and avoids them to fall in the parent artery, preventing coil protrusion.

    Accomplishes this by providing coil support at the neck of the aneurysm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morbidity and Mortality associated with stenting and coiling

    Assessment of morbidity and mortality at 30 days and 12-18 months post endovascular treatment of wide neck aneurysm with a Neurform 3 stent and coiling as assessed by the modified Rankin scale (mRS).

    Measured: 30 days and 12-18 months post procedure

Secondary outcomes (1)

  1. Efficacy of the Neuroform stent for treatment of wide neck aneurysms

    Assessment of the morphological results post endovascular coiling and stenting of wide neck aneurysms and assessment of anatomical stability of the treatment at 12-18 months post procedure

    Measured: post procedure and at 12-18 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2009 (estimated)
  2. Study startJul 2008
  3. Primary completionSep 2010
  4. Study completionDec 2010

Resources

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
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00928265
Sponsor's protocol ID
SENAT
Acronym
SENAT
Status last verified
May 2013
First submitted
23 Jun 2009
Last updated
4 Jun 2013
Results posted
No
Data monitoring committee
No

Publications

  • International subarachnoid aneurysms trials. lancet 2003 feb,1;361 (9355):430-1

  • Akpek S, Arat A, Morsi H, Klucznick RP, Strother CM, Mawad ME. Self-expandable stent-assisted coiling of wide-necked intracranial aneurysms: a single-center experience. AJNR Am J Neuroradiol. 2005 May;26(5):1223-31.

    PubMed 15891189

  • Alfke K, Straube T, Dorner L, Mehdorn HM, Jansen O. Treatment of intracranial broad-neck aneurysms with a new self-expanding stent and coil embolization. AJNR Am J Neuroradiol. 2004 Apr;25(4):584-91.

    PubMed 15090346

  • Barath K, Cassot F, Rufenacht DA, Fasel JH. Anatomically shaped internal carotid artery aneurysm in vitro model for flow analysis to evaluate stent effect. AJNR Am J Neuroradiol. 2004 Nov-Dec;25(10):1750-9.

    PubMed 15569741

  • Benitez RP, Silva MT, Klem J, Veznedaroglu E, Rosenwasser RH. Endovascular occlusion of wide-necked aneurysms with a new intracranial microstent (Neuroform) and detachable coils. Neurosurgery. 2004 Jun;54(6):1359-67; discussion 1368. doi: 10.1227/01.neu.0000124484.87635.cd.

    PubMed 15157292

  • Byrne JV, Bashiri M, Pasco A, Morris JH. A novel flexible endovascular stent for use in small and tortuous vessels. Neuroradiology. 2000 Jan;42(1):56-61. doi: 10.1007/s002340050015.

    PubMed 10663475

  • Canton G, Levy DI, Lasheras JC, Nelson PK. Flow changes caused by the sequential placement of stents across the neck of sidewall cerebral aneurysms. J Neurosurg. 2005 Nov;103(5):891-902. doi: 10.3171/jns.2005.103.5.0891.

    PubMed 16304994

  • dos Santos Souza MP, Agid R, Willinsky RA, Cusimano M, Montanera W, Wallace MC, terBrugge KG, Marotta TR. Microstent-assisted coiling for wide-necked intracranial aneurysms. Can J Neurol Sci. 2005 Feb;32(1):71-81. doi: 10.1017/s0317167100016917.

    PubMed 15825550

  • Fiorella D, Albuquerque FC, Han P, McDougall CG. Preliminary experience using the Neuroform stent for the treatment of cerebral aneurysms. Neurosurgery. 2004 Jan;54(1):6-16; discussion 16-7. doi: 10.1227/01.neu.0000097194.35781.ea.

    PubMed 14683536

  • Howington JU, Hanel RA, Harrigan MR, Levy EI, Guterman LR, Hopkins LN. The Neuroform stent, the first microcatheter-delivered stent for use in the intracranial circulation. Neurosurgery. 2004 Jan;54(1):2-5. doi: 10.1227/01.neu.0000099370.05758.4d. No abstract available.

    PubMed 14683535

  • Lylyk P, Ferrario A, Pasbon B, Miranda C, Doroszuk G. Buenos Aires experience with the Neuroform self-expanding stent for the treatment of intracranial aneurysms. J Neurosurg. 2005 Feb;102(2):235-41. doi: 10.3171/jns.2005.102.2.0235.

    PubMed 15739550

  • Murayama Y, Nien YL, Duckwiler G, Gobin YP, Jahan R, Frazee J, Martin N, Vinuela F. Guglielmi detachable coil embolization of cerebral aneurysms: 11 years' experience. J Neurosurg. 2003 May;98(5):959-66. doi: 10.3171/jns.2003.98.5.0959.

    PubMed 12744354

  • Wakhloo AK, Lanzino G, Lieber BB, Hopkins LN. Stents for intracranial aneurysms: the beginning of a new endovascular era? Neurosurgery. 1998 Aug;43(2):377-9. doi: 10.1097/00006123-199808000-00126. No abstract available.

    PubMed 9696095

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Aneurysm, run by Stryker Neurovascular at 12 sites in France.

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 9 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 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. 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?

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?

Morbidity and Mortality associated with stenting and coiling (time frame: 30 days and 12-18 months post procedure). 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 NCT00928265, which also lists 13 linked publications.

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 4 Jun 2013.

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