Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02921711
Other study ID # TRAIL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2012
Est. completion date April 2016

Study information

Verified date September 2016
Source Microvention-Terumo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

A prospective, multicenter, observational assessment of the safety and effectiveness of the LVIS® device in the treatment of wide necked intracranial aneurysms.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Patient or patient's legally authorized representative has been informed about the confidentiality of the study and has agreed to the collection of his/her personal data

2. Patient has a ruptured or unruptured intracranial aneurysm for which:

- The parent artery has a diameter = 2.0mm and = 4.5 mm;

- The aneurysm neck size is = 4mm or its dome-to-neck ratio is < 2 (wide neck)

- Endovascular treatment with coils and one or more LVIS® devices has been determined necessary for the patient by the multidisciplinary team

3. Patient is aged = 18 years

4. Patient presents with a WFNS score between 0 and 3

5. Patient has agreed to attend follow-up appointments

Exclusion Criteria:

1. The use of an endovascular stent other than LVIS® has been determined necessary

2. Patient presents with medical or surgical co-morbidities limiting his/her life expectancy to less than one year

3. Patient has a contraindication to platelet inhibition treatment

4. Patient requires retreatment of an aneurysm previously treated with a stent

5. Patient is pregnant

6. Patient has multiple aneurysms to be treated in one procedure

Study Design


Related Conditions & MeSH terms


Intervention

Device:
LVIS®
Low-profile Visualized Intraluminal Support device

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Microvention-Terumo, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm 6 months
Primary Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm 18 months
Primary Retreatment rate 6 months
Primary Retreatment rate 18 months
Primary Morbidity rate 6 months
Primary Morbidity rate 18 months
Primary Mortality rate 6 months
Primary Mortality rate 18 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02879175 - Patients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial Aneurysms
Completed NCT01139892 - The Canadian UnRuptured Endovascular Versus Surgery Trial (CURES)
Recruiting NCT06411418 - Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm N/A
Completed NCT02312856 - Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction N/A
Recruiting NCT01054391 - Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae N/A
Completed NCT02657772 - Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms
Completed NCT01465841 - Study of the Penumbra Coil 400 System to Treat Aneurysm N/A
Enrolling by invitation NCT05453240 - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device
Completed NCT03550638 - Coil System(Ton-bridgeMT) for Endovascular Embolization of Cranial Aneurysms N/A
Terminated NCT02122133 - CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
Completed NCT01541254 - Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device Phase 2/Phase 3
Terminated NCT01320306 - Intracranial Aneurysms and Cognitive Function
Recruiting NCT01084681 - Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques N/A
Completed NCT00396981 - MAPS Trial: Matrix And Platinum Science Phase 4
Recruiting NCT01031147 - Contrast-free Magnetic Resonance Angiography (MRA) at 3.0 T for Intracranial Aneurysm Detection N/A
Recruiting NCT05636124 - Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms N/A
Completed NCT02921698 - Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
Completed NCT01801007 - Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms N/A
Terminated NCT01974700 - Seizure Prophylaxis in Aneurysm Repair Phase 4
Completed NCT01793792 - Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support) N/A