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

Comparative Study of Covered Stent With Coil Embolization in the Treatment of Cranial Internal Carotid Artery Aneurysm: A Nonrandomized Prospective Trial

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01029938
Enrollment
85
Registered
2009-12-10
Start date
2005-04-30
Completion date
2010-06-30
Last updated
2010-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Aneurysms

Keywords

Intracranial aneurysms;, Covered stent;, Coil embolization

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.

Interventions

PROCEDURECovered stent

Consecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B)

PROCEDURECoil

Consecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B)

Sponsors

Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 85 Years
Healthy volunteers
No

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. -

Design outcomes

Primary

MeasureTime frame
Willis covered stent indicate good flexibility and efficacy in cranial internal carotid artery (CICA) aneurysm treatment in patients without an extremely tortuous ICA53 months after the study

Secondary

MeasureTime frame
Willis covered stents are more effective than recoiling with respect to the complete occlusion of recurrent aneurysms56 months after the study

Countries

China

Contacts

Primary ContactYong-Dong Li, MD., Ph.D.
dr_liyongdong@sina.com.cn0086-21-64844183
Backup ContactMing-Hua Li, MD.,Ph.D.
liminhua@online.sh.cn0086-21-64844183

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026