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Safety and efficacy of the stabilizer device using in endovascular therapy (SD-01 Trial)

Safety and efficacy of the stabilizer device using in endovascular therapy (SD-01 Trial)

31

Total number of samples is 31 by using the study device and the breakdown is as follows; There was no terminated sample out of the total cases. [Sex]Male : 8 samples (25.8%), Female : 23 samples (74.2%) [By age]16 samples (51.6%) by under 65 years old, 15 samples (48.4%) by over 65 years old, its average 63.7-year-old, and its median 63-year-old [Target disease]Cerebral aneurysm was 24 samples (77.4%), and cerebral artery stenosis was 7 samples (22.6%). [HPI]Asymptomatic cerebral aneurysm was 17 samples (58.1%), Symptomatic cerebral aneurysm (mass effect) was 6 samples (19.4%), other cerebral aneurysm was 1 samples (3.2%), cerebral artery stenosis which shows ischemic stroke was 6 samples (19.4%), asymptomatic cerebral artery stenosis was 1 sample (3.2%) [Modified Rankin Scale (mRS) at baseline) ] Grade 0:24 samples (77.4%), Grade 1:6 samples (19.4%), Grade 2 (3.2%):1 sample [NIHSS score at baseline] 0:24 samples (77.4%), 1~5:5 samples (16.1%), 15~24:2 samples (6.5%)

On April 22nd, 2022, the study was reviewed by IRB of Kobe City Medical Center General Hospital, and was approved on April 28th, then its notification of clinical trial plan was submitted on May 9th, 2022. IRB review has been started at each participating hospital since July 2022, and obtained approval sequentially. On 10th July, 2022, obtained consent for the 1st sample at Kobe City Medical Center General Hospital, and its procedure carried out on July 21, 2022. Procedure of the 31st sample was carried out on March 10th, 2023, and the period of observation for all samples ended on March 20, 2023.

To total 31 samples, number of samples of Adverse Event (here in after referred to as AE) was expressed 21 (67.7%), number of expressions was 51 cases. Number of Serious Adverse Event (there in after referred to as SAE) within those was 4 samples (12.9%) 4 cases, number of AE that cannot be denied to be related to the study device was 9 samples (29.0%) 9 cases, number of AE that cannot be denied to be related to cerebrovascular treatment was 18 samples (58.1%) 29 cases, number of SAE that cannot be denied to be related to the study device was 1 sample (3.2%) 1 case, number of SAE that cannot be denied to be related to cerebrovascular treatment was 3 samples (9.7%) 3 cases. In the major classification by organ, nervous system disorders had the highest rate of expression, which accounted for 54.8% of the total. Next angiopathy was 19.4%, and subsequently stomachache was 16.1%, were reported by frequency. AE which was reported by more than 2 cases were, headache (9 samples, 29.0%), stroke (8 samples, 25.8%), nausea (4 samples, 12.9%), anemia (2 samples, 6.5%), and backache (2 samples, 6.5%), the AE which was over 10% of the rate of expression was 3 cases which were headache, stroke and nausea. Further, out of the reported AE, the status of expression that cannot be denied to be related to the study equipment were stroke (6 cases), cerebral artery occlusion (1 case), headache (1 case), and extravasation at injection site (1 case). Moreover, any SAEs were classified as angiopathy, then cerebral artery occlusion, the 6th cranial nerve palsy, embolic cerebral infarction and cranial neuropathy were expressed one case each. The cerebral artery occlusion was determined cannot be denied to be related to the study device and to be related to cerebrovascular treatment, the cranial neuropathy was determined cannot be denied to be related to cerebrovascular treatment, the 6th cranial nerve palsy was determined to be related to cerebrovascular treatment. Outcome for these 3 events were all recovered or nimble. The embolic cerebral infarction was denied to be related to the study device and cerebrovascular treatment.

The success rate of therapeutic techniques as the primary endpoint of efficacy, was 96.8%, the success rate of delivery of therapeutic medical devices as a secondary endpoint efficacy was 100%, very high success rates were shown in both endpoints. The rate of subjects determined to be successful in the treatment procedure (the primary endpoint of efficacy) was 30 of 31 samples (96.8%). The success rate for each target disease was 23 of 24 samples (95.8%) for cerebral aneurysm, 7 of 7 cases (100.0%) by cerebral artery stenosis. There was no report for defect of the study device, and the success rate of delivery of therapeutic medical devices (the secondary endpoint efficacy) was 31 of 31 samples (100.0%). The rate of expression of SAE (the primary endpoint of efficacy) within 7days of treatment was 3 out of 31 samples (9.6%). In particular, the cranial neuropathy, cerebral artery occlusion and the 6th cranial nerve palsy expressed in 1 case each. Then, hemorrhagic stroke requiring treatment within 7 days of treatment or by discharge from the hospital was 0 of 31 samples (0.0%), ischemic stroke requiring treatment within 7 days of treatment or by discharge from the hospital was 3 of 31 samples (9.7%), artery dissection requiring treatment that cannot be denied to be related to the study device was 0 of 31 samples (0.0%), symptomatic angiospasm that cannot be denied to be related to the study device was 0 of 31 samples (0.0%), and other SAE that cannot be denied to be related to the study device was 0 of 31 samples (0.0%).

The study device is considered to be a promising medical device candidate that excels in both efficacy and safety and can provide effective and safe treatment for patients with cerebral aneurysms or cerebral artery stenosis who cannot deliver therapeutic medical devices to the target site by conventional methods, including replacement methods.

Mar. 31, 2025

Mar. 31, 2025

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCT2052220056

Sakai Nobuyuki

Kobe City Medical Center General Hospital

2-1-1,Minatojima minamimachi,Chuo-ku,Kobe City,Hyogo

n.sakai@siren.ocn.ne.jp

Shirono Utako

Kobe City Medical Center General Hospital

2-2 Minatojima minamimachi,Chuo-ku,Kobe City,Hyogo

+81-783024321

ushirono@kcho.jp

Complete

July. 01, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

1 Patients aged between 20years and 80years old at the time of concent acquisition
2 modified Rankin Scale is 3 or less
3 Patients with cerebral aneurysm or cerebral artery stenosis who cannot deliver therapeutic medical devices by conventional methods including replacement during endovascular treatment
4 patients who concented to the study in writing.

1. Heparin cannot be administered for medical reasons
2. It is difficult to follow up 7 days after surgery
3. Have a history of severe contrast agent allergies
4. The following patients who are contraindicated in the clinical trial device summary
(1) Patients with allergies to metals contained in the investigational equipment The following patients who are contraindicated in the investigational equipment summary
(2) Patients with carotid artery dissection, carotid cervical obstruction or vasculitis
5. Participating in other clinical trials
6. Pregnant or breastfeeding, or unwilling to use contraception during the trial (female only)
7. In addition, the investigator or the investigator has determined that it is inappropriate for conducting this clinical trial.

Both

cerebral aneurysm, cerebral artery stenosis

Deliver therapeutic equipment to lesions using unapproved devices during cerebrovascular treatment

Effectiveness assessment:Successful rate of treatment procedure
Safety evaluation:Rate of serious adverse events within 7 days of treatment

1, Rate of serious adverse events within 7 days of treatment
2. Hemorrhagic stroke requiring treatment within 7 days of treatment or until discharge
3, Ischemic stroke requiring treatment within 7 days of treatment or until discharge
4, Arterial dissection requiring treatment that cannot be denied to be related to the investigational device
5, Symptomatic vasospasm that cannot be denied to be related to the investigational device
6, Other serious adverse events that cannot be denied to be related to the investigational device

+81-783024321

April. 28, 2022

none