Chinese Registry of Assisted Embolization for Ruptured Wide Necked Intracranial Aneurysm Using LVIS Stent

Self Efficacy Clinical Trial

— CRANIAL-2  

Official title:

Chinese Registry of Assisted Embolization for Unruptured Wide Necked Intracranial Aneurysm Using LVIS Stent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02830386
• Other study ID #: CHEC2016-059
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2016
• Last updated: July 8, 2016
• Start date: June 2016
• Est. completion date: November 2018

Study information

• Verified date: July 2016
• Source: Changhai Hospital
• Contact: Qinghai Huang, Doctor
• Phone: 86-13681973064
• Email: hqhocin[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of ruptured intracranial saccular aneurysms. The follow-up duration is 1 year.

Description:

This study is a prospective multi-centre observational single-arm clinical trial, aiming to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents combined with coils for the treatment of ruptured intracranial saccular aneurysms. As the protocol, clinical follow-up at 30 days (±7 days) after procedure, DSA or MRA follow-up at 6 months (±30 days) after procedure, and clinical follow-up at 1 year (±30 days) after procedure was conducted for each patient. The primary end-points include major adverse events (cerebral infarct and death) in 30 days post-procedure, complete occlusion rate at 6 months (180±30d) follow-up, and modified Rankin Score (mRS) at 1 year follow-up. The secondary end-points were immediate technical success (successful device placement) rate, immediate complete occlusion rate, recurrence rate at 6 months (180±30d) follow-up and in-stent stenosis or obliteration rate at 6 months (180±30d) follow-up. Duration of this study is 2 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients meeting all the following criteria will be enrolled:

1. Patients of the age 18-75 years old.

2. Patients diagnosed with ruptured intracranial saccular aneurysms via CTA, MRA or DSA.

3. Patients treated with LVIS stents combined with coils.

4. Patients willing to follow the clinical trial instructions and receive follow-up assessment.

5. Patients accepting to participate to the study and sign the consent forms.

Exclusion Criteria:

• Patients meeting any following criterion will be excluded

1. Patients without proper artery approach.

2. Patients with AVM.

3. Patients with a fusiform or dissecting aneurysm.

4. Patients with a recurrent aneurysm.

5. Patients treated with a LVIS stent without coils.

6. Patients in poor clinical status, with mRS =4.

7. Patients with life expectancy less than 12 months.

8. Patients participated in other clinical trial, while has not reach the primary endpoint.

9. Patients can not accept anti-platelet regimen.

10. Patients allergic to contrast agent or intolerable.

11. Patients whom the researchers consider should not participate in or continue this clinical trial.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Medical Device Complication
• Self Efficacy

Intervention

Device:
• LVIS stent
Patients who meet the inclusion criteria will be treated with a low profile visualized intraluminal support (LVIS) stent with coils.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Cho YD, Sohn CH, Kang HS, Kim JE, Cho WS, Hwang G, Kwon OK, Ko MS, Park NM, Han MH. Coil embolization of intracranial saccular aneurysms using the Low-profile Visualized Intraluminal Support (LVIS™) device. Neuroradiology. 2014 Jul;56(7):543-51. doi: 10.1 — View Citation

Feng Z, Fang Y, Xu Y, Hong B, Zhao W, Liu J, Huang Q. The safety and efficacy of low profile visualized intraluminal support (LVIS) stents in assisting coil embolization of intracranial saccular aneurysms: a single center experience. J Neurointerv Surg. 2 — View Citation

Fiorella D, Arthur A, Boulos A, Diaz O, Jabbour P, Pride L, Turk AS, Woo HH, Derdeyn C, Millar J, Clifton A. Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device. J Neurointerv Surg. 2015 Sep 21. pii: neurintsurg-2015-011937. doi: 10.1136/neurintsurg-2015-011937. [Epub ahead of print] — View Citation

Geyik S, Yavuz K, Yurttutan N, Saatci I, Cekirge HS. Stent-assisted coiling in endovascular treatment of 500 consecutive cerebral aneurysms with long-term follow-up. AJNR Am J Neuroradiol. 2013 Nov-Dec;34(11):2157-62. doi: 10.3174/ajnr.A3574. Epub 2013 Jul 25. — View Citation

Hong Y, Wang YJ, Deng Z, Wu Q, Zhang JM. Stent-assisted coiling versus coiling in treatment of intracranial aneurysm: a systematic review and meta-analysis. PLoS One. 2014 Jan 15;9(1):e82311. doi: 10.1371/journal.pone.0082311. eCollection 2014. Review. — View Citation

Poncyljusz W, Bilinski P, Safranow K, Baron J, Zbroszczyk M, Jaworski M, Bereza S, Burke TH. The LVIS/LVIS Jr. stents in the treatment of wide-neck intracranial aneurysms: multicentre registry. J Neurointerv Surg. 2015 Jul;7(7):524-9. doi: 10.1136/neurintsurg-2014-011229. Epub 2014 May 14. — View Citation

Yang P, Zhao K, Zhou Y, Zhao R, Zhang L, Zhao W, Hong B, Xu Y, Huang Q, Krings T, Liu J. Stent-assisted Coil Placement for the Treatment of 211 Acutely Ruptured Wide-necked Intracranial Aneurysms: A Single-Center 11-Year Experience. Radiology. 2015 Aug;276(2):545-52. doi: 10.1148/radiol.2015140974. Epub 2015 Mar 30. Erratum in: Radiology. 2015 Aug;276(2):619. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse events (cerebral infarct, death) in 30 days post-procedure	Major adverse events (cerebral infarct, death) in 30 days post the procedure is defined as post-procedural cerebral infarct or death caused by any reasons	During 30 days post-procedure	Yes
Primary	Complete occlusion rate at 6 months (180±30d) follow-up	Complete occlusion at 6 months follow-up is defined as 100% occlusion of aneurysmal sac proved by DSA at 6 months follow-up	At 6 months (180±30d) follow-up	No
Primary	Modified Rankin Score at 1 year follow-up	The scale runs from 0-6, running from perfect health without symptoms to death.; 0 - No symptoms.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.	At 1 year follow-up	No
Secondary	Immediate technical success rate (successful device placement)	Immediate technical successful is defined as good apposition of stents, effective coverage of aneurysmal neck proved by post-procedural imaging examination	Within 24 hours postoperatively	No
Secondary	Immediate complete occlusion rate	Immediate Raymond scale is defined as immediate angiographic result according to the simplified Raymond scale, class?: complete occlusion; class ?: neck remnant; class ?: incomplete occlusion.	Within 24 hours postoperatively	No
Secondary	Recurrence rate at 6 months (180±30d) follow-up	Recurrence rate was defined as increased contrast filling into the aneurysmal sac compared with immediate angiographic result.	At 6 months (180±30d) follow-up	No
Secondary	In-stent stenosis or obliteration rate at 6 months (180±30d) follow-up	In-stent stenosis at 6 months follow-up is defined as stenosis more than 50% proved by DSA at 6 months follow-up. In-stent occlusion or thrombosis at 6 months follow-up is defined as complete occlusion of the stent proved by DSA at 6 months follow-up.	At 6 months (180±30d) follow-up	Yes