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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Intracranial Aneurysms	Procedure: Covered stent; Procedure: Coil	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	85 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	April 2005
Actual Primary Completion Date :	September 2008
Estimated Study Completion Date :	June 2010

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 Measures :

1. Willis covered stents are more effective than recoiling with respect to the complete occlusion of recurrent aneurysms [ Time Frame: 56 months after the study ]

Eligibility Criteria

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Ages Eligible for Study:	10 Years to 85 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Publications of Results:

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.

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.

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

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.

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
First Posted:	December 10, 2009
Last Update Posted:	July 23, 2010
Last Verified:	December 2009

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