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

July 22, 2010 updated by: Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

85

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200233
        • Recruiting
        • The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ming-Hua Li, MD.,Ph.D.
        • Sub-Investigator:
          • Bing Leng, MD.
        • Principal Investigator:
          • Yong-Dong Li, MD.,Ph.D.
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 85 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • GDCS, covered stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
53 months after the study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ANTICIPATED)

June 1, 2010

Study Registration Dates

First Submitted

December 8, 2009

First Submitted That Met QC Criteria

December 9, 2009

First Posted (ESTIMATE)

December 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 23, 2010

Last Update Submitted That Met QC Criteria

July 22, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASC2
  • SAPH002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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