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

Intracranial Aneurysms Clinical Trial

— LVIS  

Official title:

A Feasibility Study of the MicroVention,Inc.(LVIS™) Neurovascular Self-Expanding Retrievable Stent System in the Treatment of Wide-Necked Intracranial Artery Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541254
• Other study ID #: G110014
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 15, 2012
• Last updated: September 6, 2014
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2014
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

Device:
• Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	UT Southwestern	Dallas	Texas
United States	Methodist Hospital	Houston	Texas
United States	Thomas Jefferson Hospital	Philadelphia	Pennsylvania
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of = 90% at 6 Months (± 4 Weeks)	Imaging from each subject to be reviewed by an independent core lab who will be comparing with baseline and post procedure images.	6 months ± 4 weeks	No
Primary	Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months	A major stroke is defined as a new neurological event that persists for >24 hours and results in a = 4 point increase in the National Institutes of Health Stroke Scale (NIHSS) score compared to baseline or compared to any subsequent lower score.	30 days-6 months	Yes
Secondary	Parent Artery Patency Measured Angiographically at 6 Months	To be assessed by Independent Core Lab.	6 months	Yes
Secondary	Successful Delivery of the LVIS™ Device Measures by Technical Success	Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.	24 hours	No
Secondary	Significant Stenosis(>50%) of the Treated Artery at 6 Months	Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.	6 months	Yes
Secondary	Stent Migration at 6 Months	Angiographic images will be comparing post procedure sent position to 6 months	6 months	Yes
Secondary	Device and Procedure Related Serious Adverse Events	All Serious Adverse events will be reported per protocol	Day 1-6months(± 4 months)	Yes
Secondary	Unplanned Embolization Coiling Within 6 Months	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.	Day 1-6 months	No