Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms (EVIDENCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01811134
First received: November 20, 2012
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular occlusion using detachable coils, with or without expendable stent assistance. A new endovascular technique has recently been developed, using flow diverter stents without associated coils. Clinical results already published are encouraging but have to be confirmed. Furthermore, these medical devices are expensive in comparison to the coiling strategy. The purpose of this study is to compare the clinical efficacy, safety, and cost-effectiveness of endovascular coiling and endovascular flow diversion for unrupted saccular intracranial aneurysms.


Condition Intervention
Intracranial Aneurysm
Device: PIPELINE flow diverter stent
Device: Coils, with or without expendable stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Randomized Study for Medico-economic Evaluation of Embolization With Flow Diverter Stent in the Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Percentage of patients with complete occlusion of the treated aneurysm, defined as the absence of visible blood flow on angiography performed 12 months after endovascular procedure. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of a death during or after endovascular procedure [ Time Frame: hospitalization for the endovascular procedure, up to 7 days ] [ Designated as safety issue: Yes ]
  • Occurrence of a death whatever the cause [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Occurrence of a death due to aneurysm rupture [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Occurrence of an intracranial hemorrhagic from rupture of the aneurysm [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Occurrence of an ischemic stroke due to thrombosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Occurrence of a non-cerebral bleeding [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Rate of patients with neurological deficits by mass effect [ Time Frame: hospitalization for the endovascular procedure, an expected average of 1 hour; 3 months, 6 months and 12 months post-intervention ] [ Designated as safety issue: Yes ]
  • Retreatment of the aneurysm [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Rate of technical complications [ Time Frame: Endovascular procedure an expected average of 1 hour ] [ Designated as safety issue: Yes ]
  • Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others [ Time Frame: Endovascular procedure an expected average of 1 hour ] [ Designated as safety issue: Yes ]
  • Rate of correct placement of flow diverter stents, according to the investigator [ Time Frame: Endovascular procedure an expected average of 1 hour ] [ Designated as safety issue: No ]
  • mean duration of irradiation related to angiography [ Time Frame: Endovascular procedure an expected average of 1 hour ] [ Designated as safety issue: No ]
  • Rate of patients for each class of occlusion [ Time Frame: Endovascular procedure , an expected average of 1 hour and 12 months ] [ Designated as safety issue: No ]
    The classes of occlusion are defined as : complete occlusion, residual neck, residual aneurysm, for the group treated with coiling procedure; grades 0 to 4 according to the scale of Kamran, for the group treated with flow diversion

  • Modified Rankin score [ Time Frame: Inclusion, 3 months and 12 months ] [ Designated as safety issue: No ]
  • National Institute of Health Stroke Score (NIHSS) [ Time Frame: Inclusion, 3 months and 12 months ] [ Designated as safety issue: No ]
  • Evolution of the Barthel index [ Time Frame: : Inclusion and 12 months ] [ Designated as safety issue: No ]
  • Incremental cost-effectiveness ratio [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: November 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PIPELINE flow diverter stent
flow diverter stent
Device: PIPELINE flow diverter stent
endovascular procedure using the medical device PIPELINE
Device: Coils, with or without expendable stent
endovascular embolization procedure using microspires, with the possibility of using a balloon temporary and / or implantation of a stent complementary intracranial before implementation of microspires
Active Comparator: Coils, with or without expendable stent
Coils
Device: PIPELINE flow diverter stent
endovascular procedure using the medical device PIPELINE
Device: Coils, with or without expendable stent
endovascular embolization procedure using microspires, with the possibility of using a balloon temporary and / or implantation of a stent complementary intracranial before implementation of microspires

Detailed Description:

Main Outcome Measure: Percentage of patients with an aneurysm with complete occlusion, defined as the absence of visible blood flow to the consideration of angiography performed 12 months post-endovascular intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient's age ≥ 18 years old
  • Unruptured saccular intracranial aneurysm diagnosed by angiography or CT angiography or MR angiography, located in the intra-dural area, with a neck diameter between 4 and 10 mm, with a sac diameter between 7 mm and 20 mm, with a ratio "dome/nek" greater than 1, and with a diameter of the parent artery between 2 and 5 mm.
  • No prior treatment of the aneurysm
  • Agreement for participating in the study and informed consent signed by the patient
  • Patient affiliated to a social security scheme

Exclusion Criteria:

  • Patient's age < 18 years old
  • Adult patient protected by law
  • Contraindications to the endovascular procedure
  • Contraindications to antiplatelet or anticoagulant treatment
  • Prior treatment of the aneurysm
  • Presence of an arteriovenous malformation
  • Extradural location of the aneurysm
  • Fusiform aneurysm
  • Active bacterial infection (clinical signs)
  • Intracranial hemorrhage from aneurysm in the previous month
  • Pregnant or breastfeeding woman
  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: NCT01811134

Contacts
Contact: Francis Turjman, PH 33 4.72.35.74.05 francis.turjman@chu-lyon.fr
Contact: Erica Gaspak 33 4.72.11.54.38 erica.gaspak@chu-lyon.fr

Locations
France
Hospices Civils de Lyon Recruiting
Lyon, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Francis TURJMAN, PH Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01811134     History of Changes
Other Study ID Numbers: 2011.689
Study First Received: November 20, 2012
Last Updated: December 10, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hospices Civils de Lyon:
endovascular procedure; flow diverter stent

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

ClinicalTrials.gov processed this record on August 26, 2014