Treatment of Cranial Internal Carotid Artery Aneurysm With Willis Covered Stent and Coil Embolization
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ClinicalTrials.gov Identifier: NCT01029938 |
Recruitment Status
: Unknown
Verified December 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting
First Posted
: December 10, 2009
Last Update Posted
: July 23, 2010
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Condition or disease | Intervention/treatment | Phase |
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Intracranial Aneurysms | Procedure: Covered stent Procedure: Coil | Phase 4 |
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 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 |
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.
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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
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- 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 ]
- Willis covered stents are more effective than recoiling with respect to the complete occlusion of recurrent aneurysms [ Time Frame: 56 months after the study ]

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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 |
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. -

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029938
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 |
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. |
Publications of Results:
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 |
First Posted: | December 10, 2009 Key Record Dates |
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 |