Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment (SENAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT00928265
First received: June 23, 2009
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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.

Condition Intervention
Intracranial Aneurysm
Device: Endovascular treatment of intracranial aneurysm.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

Resource links provided by NLM:


Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:
  • Morbidity and Mortality associated with stenting and coiling [ Time Frame: 30 days and 12-18 months post procedure ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Efficacy of the Neuroform stent for treatment of wide neck aneurysms [ Time Frame: post procedure and at 12-18 months post procedure ] [ Designated as safety issue: No ]
    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


Enrollment: 116
Study Start Date: July 2008
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Endovascular treatment of intracranial aneurysm.

    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

    Other Names:
    • Neuroform3TM Microdelivery Stent System
    • M003E3250100,M003E3250150,M003E3250200,
    • M003E3300100,M003E3300150,M003E3300200,M003E3300300
    • M003E3350100,M003E3350150,M003E3350200,M003E3350300
    • M003E3400100,M003E3400150,M003E400200,M003E400300
    • M003E3450100,M003E3450150,M003E3450200,M003E3450300
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patient coming to the hospital to get an endovascular treatment of the aneurysm

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928265

Locations
France
Centre Hospitalier pellegrin
Bordeaux, France, 33076
CHU Hôpital de la Côte de Nacre
Caen, France, 14033
CHRU Salengro
Lille, France, 59037
CHU Limoges
Limoges, France, 87042
Hôpital Neurologique
Lyon, France, 69394
Hôpital Gui de Chauliac
Montpellier, France, 34059
CHU Nancy
Nancy, France, 54035
CHU Hôpital Guillaume et René Laënnec
Nantes, France, 44035
Hôpital Saint-Roch
Nice, France, 06000
Groupe Hospitalier Pitié-Salpétrière
Paris, France, 75013
Fondation Rotschild
Paris, France, 75019
Hôpital Lariboisière
Paris, France, 75010
Sponsors and Collaborators
Stryker Neurovascular
Investigators
Principal Investigator: Alessandra Biondi
Principal Investigator: Alain Bonafé
  More Information

Publications:

Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT00928265     History of Changes
Other Study ID Numbers: SENAT
Study First Received: June 23, 2009
Last Updated: May 31, 2013
Health Authority: France: Haute Autorité de Santé Transparency Commission
France: French Data Protection Authority

Keywords provided by Stryker Neurovascular:
intracranial
stenting
endovascular treatment
stent-assisted coiling
cerebrovascular disease

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014