The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease

Stent Restenosis Clinical Trial

Official title:

A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Efficacy and Safety of an Intracranial Self-expanding Drug Eluting Stent System for Symptomatic Intracranial Atherosclerotic Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05217459
• Other study ID #: SINOMED ISS
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 4, 2022
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Sinomed Neurovita Technology Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis.

Description:

This study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of intracranial self-expanding drug stent system in the treatment of symptomatic intracranial atherosclerotic stenosis. A total of 128 patients are planned to be included. The primary endpoint is the incidence of In-stent restenosis at 6 months after operation (ISR is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.). All patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year, and 2 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: June 2024
• Est. primary completion date: August 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 30 to 75 years of age;

2. Patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery;

3. Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in target intracranial artery

4. The target lesion was in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, and it was a single lesion that required surgical treatment;

5. The target lesion reference diameter must be visually estimated to be =2.0 mm and <4.5mm in diameter, and lesion length of =34 mm;

6. mRS < 3;

7. The onset of the latest transient ischemic attack (TIA) was not limited or ischemic stroke occurred within 2 weeks prior to stenting procedure;

8. Willingness to participate in this clinical trial and signing the consent form, and be able to complete the corresponding inspections, follow-ups, etc. according to the requirements of the clinical protocol during the clinical trial.

Exclusion Criteria:

1. The target vessels was complete occlusion;

2. >70% stenosis observed at the intracranial large-vessel distal to the target vessel or >70% stenosis observed at the intracranial/extracranial large-vessel proximal to the target vessel;

3. Preoperative magnetic resonance only showed perforating infarction in the target lesion area;

4. Preoperative CT or MRI showed that there was hemorrhage transformation after infarction in the target vessel area, or a history of primary cerebral hemorrhage, or a history of subarachnoid, subdural and epidural hemorrhage within 30 days before operation, or there was no treatment Chronic subdural hematoma =5mm;

5. Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery;

6. CT showed Severe calcified lesions;

7. Previously received endovascular treatment or surgical intervention at the target vessel (except for patients with simple balloon dilatation);

8. Non-atherosclerosis lesions;

9. Patients with potential sources of cardiac embolism (such as atrial fibrillation, left ventricular thrombosis, myocardial infarction within 6 weeks);

10. Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation;

11. Known hypersensitivity to aspirin, heparin, clopidogrel, rapamycin (sirolimus), lactic acid polymer, poly-n-butyl methacrylate, nickel-titanium alloy, or contraindications to anesthetics and contrast agents;

12. Hemoglobin <100g/L, platelet count <100*109/L, International normalized ratio (INR) >1.5 (irreversible) or uncorrectable hemorrhagic factors;

13. Uncontrollable severe hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg);

14. Known liver or renal insufficiency (ALT> 3x upper limit or AST > 3x upper limit, Serum creatinine>250µmol/L);

15. Life expectancy < 1 year;

16. Pregnant/lactating female patients;

17. Patients with cognitive impairment or mental diseases (except for those with cognitive impairment due to arterial stenosis);

18. Patients who were participated in other clinical trials within 3 months or participating in other clinical trials who had not yet reached the primary clinical endpoint;

19. Inapplicable for intravascular stenting treatment as per investigators judgment.

Related Conditions & MeSH terms

• Intracranial Arterial Diseases
• Percutaneous Transluminal Angioplasty
• Stent Restenosis

Intervention

Device:
• Self-expanding intracranial drug stent system
All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES)

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital, Capital Medical University	Beijing
China	The First Hospital of Jilin University	Changchun
China	The First People's Hospital of Changzhou	Changzhou
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	The First Affiliated Hospital of Harbin Medical University	Ha'erbin
China	Hangzhou First people's Hospital, Zhejiang University School of Medicine	Hangzhou
China	The First Affiliated Hospital of USTC Anhui provincial hospital	Hefei
China	Qilu Hospital, Shandong University	Jinan
China	The Affiliated Hospital of Qingdao University	Qingdao
China	Changhai Hospital	Shanghai
China	Shanghai Fourth People's Hospital	Shanghai
China	The First Hospital of Hebei Medical University	Shijiazhuang
China	Yantai Yu Huang Ding hospital	Yantai
China	The First Affiliated hospital of Zhengzhou hospital	Zhengzhou

Sponsors (2)

Lead Sponsor	Collaborator
Sinomed Neurovita Technology Inc.	Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of In-stent restenosis within 6 months after operation	ISR is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.	6 months after operation
Secondary	Stent success	Stent success is defined as ISS is successfully implanted into the vascular site of the target lesion with balloon pretreatment and the delivery system was successfully withdrawn.	Immediately after operative
Secondary	Procedure success	Procedure success is defined as a reduction in the degree of stenosis to = 30% after the application of any interventional treatment method.	Immediately after operative
Secondary	Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at 6 months follow-up	The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).	6 months after operation
Secondary	Rate of good functional outcomes measured by Modified Rankin Score (mRS)	Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death). This outcome measured percentage of subjects with a "good" functional outcome with a score ranging from 0-2.	30days, 6 months, 1 year ,2 years after operation
Secondary	Rate of all revascularization and target lesion revascularization	The proportion of patients who had revascularization in target lesion or not	30days, 31days to 6 months, 1 year, 2 years after operation
Secondary	Symptomatic ISR within 6 months	Symptomatic ISR is defined as ISR associated with ischemic event in the territory	within 6 months
Secondary	Any stroke or death within 30 days after operation, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year, 2 years after operation.	As a composite endpoint include any stroke or death within 30 days, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year, 2 years after operation.	30days, 31days to 6 months, 1 year, 2 years after operation
Secondary	Any stroke or death within 30 days after operation	Any stroke, death means death from any cause, including stroke or cerebrovascular disease	Within 30days after operation
Secondary	Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel	The proportion of patients who had any stroke or died within 30 days after operation in association with stenting implantion	Within 30days after operation
Secondary	The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year, 2 years after operation.	There is clear imaging evidence to confirm that the target vessel area is occluded again, which leads to ischemic stroke.	31days to 6 months, 1 year, 2 years after operation
Secondary	The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months, 1 year, 2 years after operation.	There is clear imaging evidence to confirm that outside the target vessel area is occluded again, which leads to ischemic stroke.	31days to 6 months, 1 year, 2 years after operation
Secondary	Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage	There is clear imaging evidence to confirm that the incidence of any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage	31days to 6 months, 1 year, 2 years after operation
Secondary	All cause death	The proportion of patients who died from all causes is evaluated from 31 days to 6 months, 1 year, 2 years after operation	31days to 6 months, 1 year, 2 years after operation
Secondary	Adverse events or severe adverse event	The proportion of Adverse events or severe adverse event	31days to 6 months, 1 year, 2 years after operation
Secondary	Incidence of device defects	The proportion of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc.	During operation