Intracranial AneurysmsPhase 4NCT01029938
Treatment of Cranial Internal Carotid Artery Aneurysm With Willis Covered Stent and Coil Embolization
A Phase 4 study testing Covered stent and Coil in people with Intracranial Aneurysms, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 85 years
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- Covered stent and Coil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2005to Jun 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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. -
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200233
- Recruiting
The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200233
Yong-Dong Li, MD, Ph.D., 0086-21-64844183, dr_liyongdong@sina.com.cn
Ming-Hua Li, MD, Ph.D., 0086-21-64844183, liminhua@online.sh.cn
About this study
Official title: Comparative Study of Covered Stent With Coil Embolization in the Treatment of Cranial Internal Carotid Artery Aneurysm: A Nonrandomized Prospective Trial
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.
Read the 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.
- Conditions
- Intracranial Aneurysms
- Being tested
- Covered stent, Coil
- Keywords
- Intracranial aneurysms;, Covered stent;, Coil embolization
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covered stentProcedure or surgery
Also called GDCs, covered stent
Consecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B)
CoilProcedure or surgery
Also called GDCS, covered stent
Consecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B)
| Study group | Role | What they receive |
|---|---|---|
| Covered stent | Active comparator | 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. Receives: Procedure: Covered stent; Procedure: Coil |
| Coil | Active comparator | Coil embolization, which has been widely applied for nearly two decades, is currently the endovascular approach that is first recommended for intracranial aneurysm treatment. Receives: Procedure: Covered stent; Procedure: Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willis covered stent indicate good flexibility and efficacy in cranial internal carotid artery (CICA) aneurysm treatment in patients without an extremely tortuous ICA
Measured: 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
Measured: 56 months after the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startApr 2005
- Primary completionSep 2008
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029938
- Sponsor's protocol ID
- CASC2
- Other IDs
- SAPH002
- Status last verified
- Dec 2009
- First submitted
- 8 Dec 2009
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19789235Li 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.
PubMed 19687026Li 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.
PubMed 20700595
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Covered Stent With Coil Embolization in the Treatment of Cranial Internal Carotid Artery Aneurysm: A Nonrandomized Prospective Trial
- ClinicalTrials.gov ID
- NCT01029938
- Acronym / sponsor ID
- CASC2
- Conditions
- Intracranial Aneurysms
- Keywords
- Intracranial aneurysms;, Covered stent;, Coil embolization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jun 2010 (estimated)
- First posted
- 10 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covered stent | Active comparator | Procedure: Covered stent, Procedure: CoilThe 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 comparator | Procedure: Covered stent, Procedure: CoilCoil embolization, which has been widely applied for nearly two decades, is currently the endovascular approach that is first recommended for intracranial aneurysm treatment. |
Who may qualify
- Ages
- 10 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covered stentAlso: GDCs, covered stentConsecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B) | Procedure or surgery | Coil, Covered stent |
| CoilAlso: GDCS, covered stentConsecutive patients with CICA aneurysms were endovasculartreated with a Willis covered stent (group A) or coil embolization (group B) | Procedure or surgery | Coil, Covered stent |
Primary outcome
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
1 secondary outcome
Willis covered stents are more effective than recoiling with respect to the complete occlusion of recurrent aneurysms
Time frame: 56 months after the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
- Results publication: PubMed 19789235Li 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.
- Results publication: PubMed 19687026Li 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.
- Derived from this study: PubMed 20700595Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Covered stent and Coil in people with Intracranial Aneurysms, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong-Dong Li, MD., Ph.D. (0086-21-64844183, dr_liyongdong@sina.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01029938, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2010.