Intracranial AtherosclerosisNCT04949880
A Single-Arm Trial of Neurovascular Drug-Eluting Balloon Dilatation Catheter Treating Symptomatic Intracranial Atherosclerotic Stenosis
A study testing Neurovascular Drug-Eluting Balloon Dilatation Catheter in people with Intracranial Atherosclerosis, run by Zhejiang Zylox Medical Device Co., Ltd. at 11 sites in China.
Trial summary
This is a trial designed to test the efficacy and safety of the Neurovascular Drug-Eluting Balloon Dilatation Catheter. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Atherosclerosis
- What is being tested?
- Neurovascular Drug-Eluting Balloon Dilatation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 11 sitesChina
- Study dates
- 2 Nov 2021to May 2023
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years, any gender;
- Subject has symptomatic intracranial atherosclerotic stenosis that the degree of the artery stenosis is between 70% and 99% diagnosed by intracranial angiography;
- The target stenotic artery locates in Internal Carotid Artery (intracranial segment), Middle Cerebral Artery (M1, M2), Basilar Artery, Vertebral Artery (intracranial segment);
- Intracranial artery stenosis requiring interventional treatment is a single lesion;
- Subject has at least two atherosclerosis risk factors including history or present hypertension, diabetes, hyperlipidemia, smoking, age>45;
- modified Rankin Scale(mRS) score≤2 before enrollment;
- Subject or guardian is able to understand the purpose of study, agree to provide follow-up data and has provided written informed consent.
Who cannot join
- History of acute ischemic stroke within 2 weeks;
- History of intracranial hemorrhage (including intraparenchymal hemorrhage, subarachnoid hemorrhage, subdural hemorrhage and epidural hemorrhage) within 3 months;
- Hypertension uncontrolled by medicine (Systolic pressure≥180 mmHg or diastolic pressure≥110 mmHg continuously);
- Combined with the intracranial tumor, aneurysm or intracranial arteriovenous malformation;
- The length of intracranial artery stenosis >10mm and extremely angulated >90°, which indicated by angiography;
- History of stent intervention within the target lesion;
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- Allergic to heparin, sirolimus (i.e. rapamycin), contrast agents, aspirin, clopidogrel, anesthetics;
- History of gastrointestinal hemorrhage within 6 months before signing the informed consent form, which is unable to receive antiplatelet therapy;
- Platelet (PLT)<90*10^9/L;
- Creatinine>250 umol/L;
- International Normalized Ratio (INR)>1.5;
- Female subject who is pregnant or breast-feeding, or who has a pregnancy plan within 12 months;
- Expected life <12 months;
- Unable to cooperate with or tolerate the interventional surgery;
- Subject who has participated in other drug or device clinical trials or hasn't reached the primary end point;
- Angiography indicates intracranial artery stenosis caused by arterial dissection, arteritis, and thrombosis;
- Angiography indicates the vascular path is tortuous, the experimental device is difficult to reach the target position or be retracted;
- Other circumstances judged by researchers that are not suitable for enrollment.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Beijing Chao-Yang Hospital, Capital Medical University
Beijing
Xuanwu Hospital Capital Medical University
Beijing
Cangzhou Central hospital
Cangzhou, Hebei
West China Hospital, Sichuan University
Chengdu, Sichuan
The First Affiliated Hospital of USTC
Hefei, Anhui
Linyi People's Hospital
Linyi, Shandong
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Changhai Hospital of Shanghai
Shanghai
General Hospital of Northen Theater Command
Shenyang, Liaoning
Wuhan Hospital of Traditional Chinese and Western Medicine
Wuhan, Hubei
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui
About this study
Official title: The Efficacy and Safety Study for Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis Using Neurovascular Drug-Eluting Balloon Dilatation Catheter: A Prospective Multicentre Single-arm Trial
This is a trial designed to test the efficacy and safety of the Neurovascular Drug-Eluting Balloon Dilatation Catheter.
Read the detailed description
This is a prospective multicentre single-arm trial conducted by 11 centers in mainland China. Approximately 132 subjects with symptomatic intracranial atherosclerotic stenosis receive endovascular treatment using the neurovascular drug-eluting balloon dilatation catheter designed by Zylox.
- Conditions
- Intracranial Atherosclerosis
- Being tested
- Neurovascular Drug-Eluting Balloon Dilatation Catheter
- Medical subject headings
- Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurovascular Drug-Eluting Balloon Dilatation CatheterDevice
The neurovascular drug-eluting balloon dilatation catheter consists of a tip, a drug-coated balloon, markers, a catheter and a catheter hub. The main component of the drug coating is sirolimus, and the coating is evenly distributed on the effective length surface of the balloon.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Neurovascular Drug-Eluting Balloon Dilatation Catheter Receives: Device: Neurovascular Drug-Eluting Balloon Dilatation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restenosis rate of the target lesion
Subjects receive Digital Subtraction Angiography (DSA) / Computed Tomography Angiography (CTA) examination in 180 days to analyze whether the degree of stenosis is greater than or equal to 50%, if so, the target lesion restenosis happens.
Measured: 180+60 days
Secondary outcomes (3)
Average stenosis degree of the target lesion
Subjects receive DSA / CTA examination in 180 days.
Measured: 180+60 days
Success rate of device
After receiving DSA examination, success rate of device is defined as experimental device-neurovascular drug-eluting balloon dilatation catheter advanced on position successfully, balloon retracted smoothly after expanded, without balloon rupture and balloon catheter break, etc.
Measured: Intraoperation
Success rate of surgery
After receiving DSA examination, success rate of surgery is defined as the final residual stenosis degree of target lesion<50% and modified thrombolysis in cerebral infarction score (mTICI) 2b/3, whether or not other additional treatments are applied.
Measured: Intraoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start2 Nov 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AtherosclerosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianmin Liu, Principal investigator, Changhai HospitalLiqun Jiao, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949880
- Sponsor's protocol ID
- ZYLOX34202105
- Status last verified
- Oct 2022
- First submitted
- 24 Jun 2021
- Last updated
- 17 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety Study for Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis Using Neurovascular Drug-Eluting Balloon Dilatation Catheter: A Prospective Multicentre Single-arm Trial
- ClinicalTrials.gov ID
- NCT04949880
- Acronym / sponsor ID
- ZYLOX34202105
- Conditions
- Intracranial Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 2 Jul 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.
This is a trial designed to test the efficacy and safety of the Neurovascular Drug-Eluting Balloon Dilatation Catheter.
Detailed description
This is a prospective multicentre single-arm trial conducted by 11 centers in mainland China. Approximately 132 subjects with symptomatic intracranial atherosclerotic stenosis receive endovascular treatment using the neurovascular drug-eluting balloon dilatation catheter designed by Zylox.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Neurovascular Drug-Eluting Balloon Dilatation CatheterNeurovascular Drug-Eluting Balloon Dilatation Catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 80 years, any gender;
- Subject has symptomatic intracranial atherosclerotic stenosis that the degree of the artery stenosis is between 70% and 99% diagnosed by intracranial angiography;
- The target stenotic artery locates in Internal Carotid Artery (intracranial segment), Middle Cerebral Artery (M1, M2), Basilar Artery, Vertebral Artery (intracranial segment);
- Intracranial artery stenosis requiring interventional treatment is a single lesion;
- Subject has at least two atherosclerosis risk factors including history or present hypertension, diabetes, hyperlipidemia, smoking, age>45;
Key exclusion criteria (18 listed)
- History of acute ischemic stroke within 2 weeks;
- History of intracranial hemorrhage (including intraparenchymal hemorrhage, subarachnoid hemorrhage, subdural hemorrhage and epidural hemorrhage) within 3 months;
- Hypertension uncontrolled by medicine (Systolic pressure≥180 mmHg or diastolic pressure≥110 mmHg continuously);
- Combined with the intracranial tumor, aneurysm or intracranial arteriovenous malformation;
- The length of intracranial artery stenosis >10mm and extremely angulated >90°, which indicated by angiography;
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 |
|---|---|---|
| Neurovascular Drug-Eluting Balloon Dilatation CatheterThe neurovascular drug-eluting balloon dilatation catheter consists of a tip, a drug-coated balloon, markers, a catheter and a catheter hub. The main component of the drug coating is sirolimus, and the coating is evenly distributed on the effective length surface of the balloon. | Device | Group A |
Primary outcome
Restenosis rate of the target lesion
Time frame: 180+60 days
Subjects receive Digital Subtraction Angiography (DSA) / Computed Tomography Angiography (CTA) examination in 180 days to analyze whether the degree of stenosis is greater than or equal to 50%, if so, the target lesion restenosis happens.
3 secondary outcomes
Average stenosis degree of the target lesion
Time frame: 180+60 days
Success rate of device
Time frame: Intraoperation
Success rate of surgery
Time frame: Intraoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
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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.
Jianmin Liu principal investigator
Changhai Hospital
Liqun Jiao principal investigator
Xuanwu Hospital, Beijing
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurovascular Drug-Eluting Balloon Dilatation Catheter in people with Intracranial Atherosclerosis, run by Zhejiang Zylox Medical Device Co., Ltd. at 11 sites in China.
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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Restenosis rate of the target lesion (time frame: 180+60 days). 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 17 Oct 2022.