Medical Device Complication, Self Efficacy
Conditions
Brief summary
This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of ruptured intracranial saccular aneurysms. The follow-up duration is 1 year.
Detailed description
This study is a prospective multi-centre observational single-arm clinical trial, aiming to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents combined with coils for the treatment of ruptured intracranial saccular aneurysms. As the protocol, clinical follow-up at 30 days (±7 days) after procedure, DSA or MRA follow-up at 6 months (±30 days) after procedure, and clinical follow-up at 1 year (±30 days) after procedure was conducted for each patient. The primary end-points include major adverse events (cerebral infarct and death) in 30 days post-procedure, complete occlusion rate at 6 months (180±30d) follow-up, and modified Rankin Score (mRS) at 1 year follow-up. The secondary end-points were immediate technical success (successful device placement) rate, immediate complete occlusion rate, recurrence rate at 6 months (180±30d) follow-up and in-stent stenosis or obliteration rate at 6 months (180±30d) follow-up. Duration of this study is 2 years.
Interventions
DEVICELVIS stent
Patients who meet the inclusion criteria will be treated with a low profile visualized intraluminal support (LVIS) stent with coils.
Sponsors
Changhai Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients meeting all the following criteria will be enrolled: 1. Patients of the age 18-75 years old. 2. Patients diagnosed with ruptured intracranial saccular aneurysms via CTA, MRA or DSA. 3. Patients treated with LVIS stents combined with coils. 4. Patients willing to follow the clinical trial instructions and receive follow-up assessment. 5. Patients accepting to participate to the study and sign the consent forms.
Exclusion criteria
* Patients meeting any following criterion will be excluded 1. Patients without proper artery approach. 2. Patients with AVM. 3. Patients with a fusiform or dissecting aneurysm. 4. Patients with a recurrent aneurysm. 5. Patients treated with a LVIS stent without coils. 6. Patients in poor clinical status, with mRS ≥4. 7. Patients with life expectancy less than 12 months. 8. Patients participated in other clinical trial, while has not reach the primary endpoint. 9. Patients can not accept anti-platelet regimen. 10. Patients allergic to contrast agent or intolerable. 11. Patients whom the researchers consider should not participate in or continue this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse events (cerebral infarct, death) in 30 days post-procedure | During 30 days post-procedure | Major adverse events (cerebral infarct, death) in 30 days post the procedure is defined as post-procedural cerebral infarct or death caused by any reasons |
| Complete occlusion rate at 6 months (180±30d) follow-up | At 6 months (180±30d) follow-up | Complete occlusion at 6 months follow-up is defined as 100% occlusion of aneurysmal sac proved by DSA at 6 months follow-up |
| Modified Rankin Score at 1 year follow-up | At 1 year follow-up | The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate technical success rate (successful device placement) | Within 24 hours postoperatively | Immediate technical successful is defined as good apposition of stents, effective coverage of aneurysmal neck proved by post-procedural imaging examination |
| In-stent stenosis or obliteration rate at 6 months (180±30d) follow-up | At 6 months (180±30d) follow-up | In-stent stenosis at 6 months follow-up is defined as stenosis more than 50% proved by DSA at 6 months follow-up. In-stent occlusion or thrombosis at 6 months follow-up is defined as complete occlusion of the stent proved by DSA at 6 months follow-up. |
| Immediate complete occlusion rate | Within 24 hours postoperatively | Immediate Raymond scale is defined as immediate angiographic result according to the simplified Raymond scale, classⅠ: complete occlusion; class Ⅱ: neck remnant; class Ⅲ: incomplete occlusion. |
| Recurrence rate at 6 months (180±30d) follow-up | At 6 months (180±30d) follow-up | Recurrence rate was defined as increased contrast filling into the aneurysmal sac compared with immediate angiographic result. |
Countries
China
Contacts
Primary ContactQinghai Huang, Doctor
Backup ContactYongxin Zhang, Doctor
Outcome results
None listed