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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01029938
First received: December 8, 2009
Last updated: July 22, 2010
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Intracranial Aneurysms
 Procedure: Covered stent
Procedure: Coil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Study of Covered Stent With Coil Embolization in the Treatment of Cranial Internal Carotid Artery Aneurysm: A Nonrandomized Prospective Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

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 [ Time Frame: 53 months after the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Willis covered stents are more effective than recoiling with respect to the complete occlusion of recurrent aneurysms [ Time Frame: 56 months after the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 85
Study Start Date: April 2005
Estimated Study Completion Date: June 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Covered stent
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.
 Procedure: Covered stent
Consecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B)
Other Name: GDCs, covered stent
Procedure: Coil
Consecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B)
Other Name: GDCS, covered stent
Active Comparator: Coil
Coil embolization, which has been widely applied for nearly two decades, is currently the endovascular approach that is first recommended for intracranial aneurysm treatment.
 Procedure: Covered stent
Consecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B)
Other Name: GDCs, covered stent
Procedure: Coil
Consecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B)
Other Name: GDCS, covered stent

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.

  Eligibility

Ages Eligible for Study:   10 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029938

Contacts
Contact: Yong-Dong Li, MD., Ph.D. 0086-21-64844183 dr_liyongdong@sina.com.cn
Contact: Ming-Hua Li, MD.,Ph.D. 0086-21-64844183 liminhua@online.sh.cn

Locations
China, Shanghai
The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200233
The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200233
Contact: Yong-Dong Li, MD, Ph.D.     0086-21-64844183     dr_liyongdong@sina.com.cn    
Contact: Ming-Hua Li, MD, Ph.D.     0086-21-64844183     liminhua@online.sh.cn    
Principal Investigator: Ming-Hua Li, MD.,Ph.D.            
Sub-Investigator: Bing Leng, MD.            
Principal Investigator: Yong-Dong Li, MD.,Ph.D.            
Sub-Investigator: Hua-Qiao Tan, MD, PhD            
Sub-Investigator: Chun Fang, MD.            
Sub-Investigator: Wu Wang, MD.            
Sub-Investigator: Dong-Lei Song, MD.            
Sub-Investigator: Pei-Lei Zhang, MD.            
Sub-Investigator: Yan-Long Tian, MD.            
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Cerebral aneurysm study in China, The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT01029938     History of Changes
Other Study ID Numbers: CASC2, SAPH002
Study First Received: December 8, 2009
Last Updated: July 22, 2010
Health Authority: China: National Natural Science Foundation

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Intracranial aneurysms;
Covered stent;
Coil embolization

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013