Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier:
NCT01541254
First received: February 15, 2012
Last updated: July 26, 2013
Last verified: July 2013

February 15, 2012
July 26, 2013
March 2012
June 2013   (final data collection date for primary outcome measure)
  • Probable benefit measures as successful aneurysm treatment with the LVIS™ device, as measured by aneurysm angiographic occlusion of ≥ 90% at 6 months (± 4 weeks) [ Time Frame: 6 months ± 4 weeks ] [ Designated as safety issue: No ]
    Imaging from each subject to be reviewed by an independent core lab who will be comparing with baseline and post procedure images.
  • Safety measures as any major stroke or death within 30 days, or major ipsi-lateral stroke or neurological death within 6 months [ Time Frame: 30 days-6 months ] [ Designated as safety issue: Yes ]
    A major stroke is defined as a new neurological event that persists for >24 hours and results in a ≥ 4 point increase in the NIHSS score compared to baseline or compared to any subsequent lower score.
Same as current
Complete list of historical versions of study NCT01541254 on ClinicalTrials.gov Archive Site
  • Parent artery patency measured angiographically at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    To be assessed by Independent Core Lab.
  • Successful delivery of the LVIS™ device measures by technical success [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.
  • Significant stenosis(>50%) of the treated artery at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.
  • Stent migration at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Angiographic images will be comparing post procedure sent position to 6 months
  • Device and procedure related Serious Adverse Events [ Time Frame: Day 1-6months(± 4 months) ] [ Designated as safety issue: Yes ]
    All Serious Adverse events will be reported per protocol
  • Unplanned embolization coiling within 6 months [ Time Frame: Day 1-6 months ] [ Designated as safety issue: No ]
    If the target lesion(aneurysm)treated needed further embolization within 6 months of initial treatment(detected during follow up or unscheduled visit ),data will be recorded and analyzed.
Same as current
Not Provided
Not Provided
 
Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device
A Feasibility Study of the MicroVention,Inc.(LVIS™) Neurovascular Self-Expanding Retrievable Stent System in the Treatment of Wide-Necked Intracranial Artery Aneurysms

The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with bare platinum embolization coils.

With the stent-assisted technique to treat wide neck intracranial aneurysms, the neurovascular stent is placed across the aneurysm neck, to act as a bridge to prevent coils from protruding into the parent artery. Stenting may allow to more safely achieve a higher packing density of coils. These effects may improve the rates of complete aneurysm occlusion and enhance the durability of the coiling treatment.The LVIS™ device manufactured by MicroVention, Inc. has a braided design which may provide superior conformability and parent artery apposition, as well as a more reliable continuous and uniform neck bridging than other neurovascular stents.

Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Intracranial Aneurysms
Device: LVIS ™ and LVIS™Jr. MicroVention
(LVIS ™ and LVIS ™ Jr.)MicroVention
Other Names:
  • LVIS™ and LVIS™ Jr. MicroVention
  • Low-profile Vizualized Intraluminal Support Device
Single Arm
Device: LVIS ™ and LVIS™Jr. MicroVention
Intervention: Device: LVIS ™ and LVIS™Jr. MicroVention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject whose age is between 18 and 80 years old
  • Subject with unruptured wide neck, saccular,intracranial aneurysm, < 20mm maximum diameter in any plane ( wide neck defined as neck width ≥ 4mm or dome to-neck ratio < 2).
  • Subject's aneurysm arises from a parent vessel with a diameter of ≥ 2.5m and ≤ 4.5mm.
  • Subject or his/her legally authorized representative understands the nature of the procedure and provides signed informed consent form.
  • Subject is willing to return to the investigational site for the 30- day and 6-month follow-up evaluations

Exclusion Criteria:

  • Subject who presents with ruptured aneurysm, unless rupture occured 30 days or more prior to screening.
  • Subject who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
  • Subject with an International Normalized Ratio (INR)≥ 1.5
  • Subject with serum creatinine level >2mg/dl at time of enrollment
  • Subject with known allergies to nickel-titanium metal
  • Subject with known allergies to aspirin, heparin, ticlopidine, or clopidogrel
  • Subject with a life threatening allergy to contrast(unless treatment for allergy is tolerated)
  • Subject who has a known cardiac disorder, likely to be associated with cardioembolic symptoms such as AFIB (atrial fibrillation)
  • Subject with any condition which in the opinion of the treating physician would place the subject at a high risk of embolic stroke
  • Subject who is currently participating in another clinical research study
  • Subject who has had a previous intracranial stenting procedure associated with the target aneurysm
  • Subject who is unable to complete the required follow-up
  • Subject who is pregnant or breastfeeding
  • Subject who has participated in a drug study within the last 30 days
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01541254
G110014
Yes
Microvention-Terumo, Inc.
Microvention-Terumo, Inc.
Not Provided
Principal Investigator: David Fiorella, M.D., Ph.D. Stony Brook University Medical Center
Microvention-Terumo, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP