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
2 other identifiers
interventional
85
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2005
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 8, 2009
CompletedFirst Posted
Study publicly available on registry
December 10, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJuly 23, 2010
December 1, 2009
3.4 years
December 8, 2009
July 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Willis covered stent indicate good flexibility and efficacy in cranial internal carotid artery (CICA) aneurysm treatment in patients without an extremely tortuous ICA
53 months after the study
Secondary Outcomes (1)
Willis covered stents are more effective than recoiling with respect to the complete occlusion of recurrent aneurysms
56 months after the study
Study Arms (2)
Covered stent
ACTIVE COMPARATORThe 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
ACTIVE COMPARATORCoil embolization, which has been widely applied for nearly two decades, is currently the endovascular approach that is first recommended for intracranial aneurysm treatment.
Interventions
Consecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B)
Consecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200233, China
The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200233, China
Related Publications (3)
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.
PMID: 19789235RESULTLi 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.
PMID: 19687026RESULTLi 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.
PMID: 20700595DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 8, 2009
First Posted
December 10, 2009
Study Start
April 1, 2005
Primary Completion
September 1, 2008
Study Completion
June 1, 2010
Last Updated
July 23, 2010
Record last verified: 2009-12