Skip to main content
OpenTrials
Completed

NCT Number: NCT05049564

Comparison of Clipping Via Keyhole Versus Traditional Approaches and Coiling for Ruptured Aneurysms

Endovascular coiling has become a strategy of choice of intracranial aneurysms due to its minimally invasiveness. However, there has few prospective randomized controlled studies on the comparison of therapeutic effect between endovascular coiling and microsurgical clipping, especially the latter via keyhole approaches, which has been widely used in recent years. Based on the data of a single center, a randomized controlled study was conducted on patients with ruptured anterior circulation aneurysms suitable for both endovascular and extravascular treatment, including endovascular coiling, microsurgical clipping via conventional craniotomy and keyhole approaches, in order to compare the efficacy of the above strategies and provide more objective basis for treatment selection for operators.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Consecutive patients of a single center will be screened. If spontaneous subarachnoid hemorrhage (SAH) is confirmed by head computed tomography (CT), a diagnostic CT angiography (CTA) or digital subtraction angiography (DSA) will be carried out emergently. A patients harbored a single intracranial aneurysm of anterior circulation that resulted in SAH will be concerned. Based on the assessment of condition, the patient will enrolled into this study without indication of decompressive craniectomy. The enrolled patients will be divided randomly into 3 groups, who experienced endovascular coiling, microsurgical clipping via conventional craniotomy and via keyhole approaches. All of these treatment will be conducted by a same senior neurosurgeon. CTA or DSA were followed up regularly. The occlusion rate, operative period, hospitalization duration and cost, surgical complications were compared and analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Single intracranial anterior circulation aneurysm diagnosed by CTA or DSA
  • CT showed that subarachnoid hemorrhage originated from the rupture of the aneurysm and was confirmed during operation
  • No indication of decompressive craniectomy (Hunt-Hess grade ≤ 4, Glasgow Coma Scale ≥ 7, no brain herniation; CT showed midline displacement < 5mm)
  • The aneurysm is suitable for both endovascular treatment and microsurgical clipping

Exclusion criteria

  • The patients and their families did not agree to join the study
  • Patients with unruptured anterior circulation aneurysms
  • Patients with posterior circulation aneurysms
  • Patients with multiple intracranial aneurysms
  • Those who cannot receive treatment due to serious concomitant diseases

Treatment and study plan

keyhole microneurosurgery

Procedure

microsurgical clipping via keyhole approach

conventional microneurosurgery

Procedure

microsurgical clipping via conventional craniotomy

endovascular coiling

Procedure

endovascular coiling via femoral approach

Primary outcomes

  1. occlusion rate of aneurysm

    Time frame: an average of 1 month

    occlusion rate of aneurysm

  2. operative time

    Time frame: an average of 1 month

    total operative duration

  3. hospitalization time

    Time frame: up to 3 months after discharge

    hospitalization duration

  4. hospitalization cost

    Time frame: up to 3 months after discharge

    cost during hospitalization

  5. postoperative complication rate

    Time frame: up to 3 months after discharge

    complication rate after intervention

Secondary outcomes

  1. recurrent rate of aneurysm

    Time frame: 6 months after treatment

    recurrent rate after treatment of aneurysm

  2. long-term complication rate

    Time frame: 6 months after treatment

    complication rate during follow-up

Sponsors and collaborators

Lead sponsor

ZhuQing

Other

Registry information

Official study title

A Randomized Controlled Study of Microsurgical Clipping Via Keyhole Approaches Versus Traditional Open Approaches and Endovascular Coiling for Ruptured Anterior Circulation Aneurysms

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Sep 20, 2021
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.