Randomized Controlled TrialNCT05049564
Comparison of Clipping Via Keyhole Versus Traditional Approaches and Coiling for Ruptured Aneurysms
A study testing keyhole microneurosurgery, conventional microneurosurgery and endovascular coiling in people with Randomized Controlled Trial and Intracranial Aneurysm, run by ZhuQing.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Randomized Controlled Trial, Intracranial Aneurysm, Microsurgery
- What is being tested?
- keyhole microneurosurgery, conventional microneurosurgery and endovascular coiling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 Dec 2018
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Randomized Controlled Study of Microsurgical Clipping Via Keyhole Approaches Versus Traditional Open Approaches and Endovascular Coiling for Ruptured Anterior Circulation 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.
Read the detailed description
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.
- Being tested
- keyhole microneurosurgery, conventional microneurosurgery, endovascular coiling
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
keyhole microneurosurgeryProcedure or surgery
microsurgical clipping via keyhole approach
conventional microneurosurgeryProcedure or surgery
microsurgical clipping via conventional craniotomy
endovascular coilingProcedure or surgery
endovascular coiling via femoral approach
| Study group | Role | What they receive |
|---|---|---|
| keyhole group | Experimental | patient harbored aneurysm who was treated by microsurgical clipping via keyhole approach. Receives: Procedure: keyhole microneurosurgery |
| conventional group | Experimental | patient harbored aneurysm who was treated by microsurgical clipping via conventional craniotomy. Receives: Procedure: conventional microneurosurgery |
| endovascular group | Experimental | patient harbored aneurysm who was treated by endovascular coiling via femoral approach. Receives: Procedure: endovascular coiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
occlusion rate of aneurysm
occlusion rate of aneurysm
Measured: an average of 1 month
operative time
total operative duration
Measured: an average of 1 month
hospitalization time
hospitalization duration
Measured: up to 3 months after discharge
hospitalization cost
cost during hospitalization
Measured: up to 3 months after discharge
postoperative complication rate
complication rate after intervention
Measured: up to 3 months after discharge
Secondary outcomes (2)
recurrent rate of aneurysm
recurrent rate after treatment of aneurysm
Measured: 6 months after treatment
long-term complication rate
complication rate during follow-up
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start1 Jan 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Randomized Controlled TrialStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZhuQing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ZhuQing, Second Affiliated Hospital of Soochow University
- Investigators
- Qing Lan, Doctor, Study director, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049564
- Sponsor's protocol ID
- SJWKvascular001
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Microsurgical Clipping Via Keyhole Approaches Versus Traditional Open Approaches and Endovascular Coiling for Ruptured Anterior Circulation Aneurysms
- ClinicalTrials.gov ID
- NCT05049564
- Acronym / sponsor ID
- SJWKvascular001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- ZhuQingUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Sep 2021 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| keyhole group | Experimental | Procedure: keyhole microneurosurgerypatient harbored aneurysm who was treated by microsurgical clipping via keyhole approach. |
| conventional group | Experimental | Procedure: conventional microneurosurgerypatient harbored aneurysm who was treated by microsurgical clipping via conventional craniotomy. |
| endovascular group | Experimental | Procedure: endovascular coilingpatient harbored aneurysm who was treated by endovascular coiling via femoral approach. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| keyhole microneurosurgerymicrosurgical clipping via keyhole approach | Procedure or surgery | keyhole group |
| conventional microneurosurgerymicrosurgical clipping via conventional craniotomy | Procedure or surgery | conventional group |
| endovascular coilingendovascular coiling via femoral approach | Procedure or surgery | endovascular group |
Primary outcome
occlusion rate of aneurysm
Time frame: an average of 1 month
occlusion rate of aneurysm
operative time
Time frame: an average of 1 month
total operative duration
hospitalization time
Time frame: up to 3 months after discharge
hospitalization duration
hospitalization cost
Time frame: up to 3 months after discharge
cost during hospitalization
postoperative complication rate
Time frame: up to 3 months after discharge
complication rate after intervention
2 secondary outcomes
recurrent rate of aneurysm
Time frame: 6 months after treatment
long-term complication rate
Time frame: 6 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Randomized Controlled Trial
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
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.
Qing Lan, Doctor study director
Second Affiliated Hospital of Soochow University
Questions about this trial
What is this clinical trial studying?
A study testing keyhole microneurosurgery, conventional microneurosurgery and endovascular coiling in people with Randomized Controlled Trial and Intracranial Aneurysm, run by ZhuQing.
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 5 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: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occlusion rate of aneurysm (time frame: an average of 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2021.