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Treatment of Cranial Internal Carotid Artery Aneurysm With Willis Covered Stent and Coil Embolization

Primary Purpose

Intracranial Aneurysms

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Covered stent
Coil
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysms focused on measuring Intracranial aneurysms;, Covered stent;, Coil embolization

Eligibility Criteria

10 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Definite CICA aneurysm, either ruptured or unruptured, as demonstrated by arterial angiography;
  2. Parent artery diameter of 3.0-5.0 mm;
  3. Good tolerance of BOT; and
  4. At least one control angiogram taken > 6 months after the initial treatment

Exclusion Criteria:

  1. An extremely tortuous vessel proximal to the parent artery and/or lack of appropriate accessible routes, thereby rendering the patient unsuitable for endovascular treatment;
  2. Parent artery diameter of < 3 mm or > 5.0 mm;
  3. Inability of the patient to undergo general anesthesia or endovascular intervention; or
  4. Expected patient survival of < 1 year because of other co-existing diseases. -

Sites / Locations

  • The Sixth Affiliated People's Hospital, Shanghai Jiao Tong UniversityRecruiting
  • The Sixth Affiliated People's Hospital, Shanghai Jiao Tong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Covered stent

Coil

Arm Description

The Willis covered stent specifically designed for intracranial vasculature was developed by our institution and the MicroPort Medical Company (Shanghai, China), and coil embolization, which has been widely applied for nearly two decades, is currently the endovascular approach that is first recommended for intracranial aneurysm treatment.

Coil embolization, which has been widely applied for nearly two decades, is currently the endovascular approach that is first recommended for intracranial aneurysm treatment.

Outcomes

Primary Outcome Measures

Willis covered stent indicate good flexibility and efficacy in cranial internal carotid artery (CICA) aneurysm treatment in patients without an extremely tortuous ICA

Secondary Outcome Measures

Willis covered stents are more effective than recoiling with respect to the complete occlusion of recurrent aneurysms

Full Information

First Posted
December 8, 2009
Last Updated
July 22, 2010
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01029938
Brief Title
Treatment of Cranial Internal Carotid Artery Aneurysm With Willis Covered Stent and Coil Embolization
Official Title
Comparative Study of Covered Stent With Coil Embolization in the Treatment of Cranial Internal Carotid Artery Aneurysm: A Nonrandomized Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Intracranial aneurysm treatment with coil embolization is associated with relatively low complete occlusion and high recanalization rates. The investigators evaluate whether Willis covered stent implantation yields angiographic and clinical results superior to those with coil embolization.
Detailed Description
Endovascular treatment of intracranial aneurysms with detachable coils has been widely used since the introduction of GDCs in 1991 and has been proven to be effective in preventing rebleeding after aneurysmal rupture. The clinical and angiographic results of endovascular coil occlusion of intracranial aneurysms are positive, with an initial and final overall complete occlusion rate of 35.9%-76.8% and 38.3%- 87.8%. In the mid- and long-term, however, aneurysm recanalization may occur in as many as one-third of cases. The natural history of aneurysm recurrence after coil treatment is often benign, but bleeding from incompletely coiled aneurysms is a well-documented threat, moreover, the degree of aneurysm occlusion after treatment was strongly associated with risk of rerupture. Even if 100% occlusion of the aneurysms after the initial treatment was obtained on immediate postembolization angiography, there was still a relatively high recanalization rate (26.4%) on long-term follow-up angiography. In a recent study, we have confirmed that there was still aneurysm perfusion of the aneurysm sac in a complete occluded aneurysm no matter on initial or follow-up rotate digital angiography. In addition, some authors have demonstrated that endothelialization of the aneurysm orifice following placement of GDCs can occur; however, it appears to be the exception rather than the rule. To overcome these disadvantages, the Willis covered stent, specially designed for intracranial vasculature, has been developed by our institution and the MicroPort Medical Company (Micro-Port, Shanghai, China). Our preliminary results demonstrated good flexibility and efficacy of the Willis covered stent in the treatment of cranial internal carotid artery aneurysms (CICA) in patients without an extremely tortuous ICA (Radiology 2009; 253:470-7), and also the covered stents have been proved to be more effective than re-coiling with regard to complete occlusion of recurrent aneurysms (J Neurol Neurosurg Psychiatry 2009;16:[Epub ahead of print]). Since 2005, we have performed a nonrandomized prospective trial of endovascular treatment CICA aneurysms with a covered stenting or coil embolization. So, we evaluate whether implantation of a primary Willis covered stent yielded angiographic and clinical results that superior to those with the currently recommended approach of coil embolization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysms
Keywords
Intracranial aneurysms;, Covered stent;, Coil embolization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Covered stent
Arm Type
Active Comparator
Arm Description
The Willis covered stent specifically designed for intracranial vasculature was developed by our institution and the MicroPort Medical Company (Shanghai, China), and coil embolization, which has been widely applied for nearly two decades, is currently the endovascular approach that is first recommended for intracranial aneurysm treatment.
Arm Title
Coil
Arm Type
Active Comparator
Arm Description
Coil embolization, which has been widely applied for nearly two decades, is currently the endovascular approach that is first recommended for intracranial aneurysm treatment.
Intervention Type
Procedure
Intervention Name(s)
Covered stent
Other Intervention Name(s)
GDCs, covered stent
Intervention Description
Consecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B)
Intervention Type
Procedure
Intervention Name(s)
Coil
Other Intervention Name(s)
GDCS, covered stent
Intervention Description
Consecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B)
Primary Outcome Measure Information:
Title
Willis covered stent indicate good flexibility and efficacy in cranial internal carotid artery (CICA) aneurysm treatment in patients without an extremely tortuous ICA
Time Frame
53 months after the study
Secondary Outcome Measure Information:
Title
Willis covered stents are more effective than recoiling with respect to the complete occlusion of recurrent aneurysms
Time Frame
56 months after the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Definite CICA aneurysm, either ruptured or unruptured, as demonstrated by arterial angiography; Parent artery diameter of 3.0-5.0 mm; Good tolerance of BOT; and At least one control angiogram taken > 6 months after the initial treatment Exclusion Criteria: An extremely tortuous vessel proximal to the parent artery and/or lack of appropriate accessible routes, thereby rendering the patient unsuitable for endovascular treatment; Parent artery diameter of < 3 mm or > 5.0 mm; Inability of the patient to undergo general anesthesia or endovascular intervention; or Expected patient survival of < 1 year because of other co-existing diseases. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong-Dong Li, MD., Ph.D.
Phone
0086-21-64844183
Email
dr_liyongdong@sina.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Hua Li, MD.,Ph.D.
Phone
0086-21-64844183
Email
liminhua@online.sh.cn
Facility Information:
Facility Name
The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Recruiting
Facility Name
The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong-Dong Li, MD, Ph.D.
Phone
0086-21-64844183
Email
dr_liyongdong@sina.com.cn
First Name & Middle Initial & Last Name & Degree
Ming-Hua Li, MD, Ph.D.
Phone
0086-21-64844183
Email
liminhua@online.sh.cn
First Name & Middle Initial & Last Name & Degree
Ming-Hua Li, MD.,Ph.D.
First Name & Middle Initial & Last Name & Degree
Bing Leng, MD.
First Name & Middle Initial & Last Name & Degree
Yong-Dong Li, MD.,Ph.D.
First Name & Middle Initial & Last Name & Degree
Hua-Qiao Tan, MD, PhD
First Name & Middle Initial & Last Name & Degree
Chun Fang, MD.
First Name & Middle Initial & Last Name & Degree
Wu Wang, MD.
First Name & Middle Initial & Last Name & Degree
Dong-Lei Song, MD.
First Name & Middle Initial & Last Name & Degree
Pei-Lei Zhang, MD.
First Name & Middle Initial & Last Name & Degree
Yan-Long Tian, MD.

12. IPD Sharing Statement

Citations:
PubMed Identifier
19789235
Citation
Li MH, Li YD, Tan HQ, Luo QY, Cheng YS. Treatment of distal internal carotid artery aneurysm with the willis covered stent: a prospective pilot study. Radiology. 2009 Nov;253(2):470-7. doi: 10.1148/radiol.2532090037. Epub 2009 Sep 29.
Results Reference
result
PubMed Identifier
19687026
Citation
Li YD, Li MH, Gao BL, Fang C, Cheng YS, Wang W, Li WB, Zhao JG, Zhang PL, Wang J, Li M. Endovascular treatment of recurrent intracranial aneurysms with re-coiling or covered stents. J Neurol Neurosurg Psychiatry. 2010 Jan;81(1):74-9. doi: 10.1136/jnnp.2009.171967. Epub 2009 Aug 16.
Results Reference
result
PubMed Identifier
20700595
Citation
Li MH, Leng B, Li YD, Tan HQ, Wang W, Song DL, Tian YL. Comparative study of covered stent with coil embolization in the treatment of cranial internal carotid artery aneurysm: a nonrandomized prospective trial. Eur Radiol. 2010 Nov;20(11):2732-9. doi: 10.1007/s00330-010-1854-z. Epub 2010 Aug 11.
Results Reference
derived

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Treatment of Cranial Internal Carotid Artery Aneurysm With Willis Covered Stent and Coil Embolization

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