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StrokeSPINASNCT06047964

SeQuent ® Please CIS for the Treatment of INtracranial Atherosclerotic Stenosis

A study testing DCB and POBA in people with Stroke and Intracranial Atherosclerotic Stenosis, run by B. Braun Medical International Trading Company Ltd. at 9 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is aiming to evaluate the safety and efficacy of SeQuent® Please CIS in the endovascular treatment of symptomatic intracranial atherosclerotic stenosis and restenosis after interventional therapy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke, Intracranial Atherosclerotic Stenosis
What is being tested?
DCB and POBA
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
281 participants
Where
9 sitesChina
Study dates
23 Mar 2023to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Aged 18 to 80 years old (including boundary value), gender is not limited;
  • The target lesion of the patient is a symptomatic intracranial atherosclerotic stenosis lesion (applicable to Sub-study A only) or restenosis lesions after interventional therapy (applicable only to Sub-study B);
  • Symptomatic intracranial arterial stenosis (intracranial segment of internal carotid artery (Petrous segment and above), middle cerebral artery, intracranial segment of vertebral artery, basilar artery, etc.) within 6 months, the degree of stenosis of the diseased artery is between 70% and 99% (WASID method);
  • Patients with symptoms occurring more than once (symptoms refer to stroke or transient ischemic attacks) after intensive drug therapy of internal medicine (including antiplatelet therapy, antihypertensive therapy, hypoglycemic therapy and lipid-lowering therapy);
  • The intracranial arterial stenosis lesion to be treated is a single lesion;
  • Patients with at least 1 risk factor for intracranial atherosclerotic plaque, including previous or existing hypertension, hyperlipidemia, diabetes, smoking;
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  • Preoperative mRS ≤ 2, and NIHSS≤8;
  • Patients whose life expectancy is greater than 12 months as assessed by the investigator.
  • Patients or their guardians can understand the trial purpose, voluntarily participate in and sign the informed consent form, and can accept follow-up visits.

Who cannot join

  • Severe calcification in the target vessel, severe distortion of the target vessel or anatomical factors that make it hard for interventional devices to be in place;
  • Ischemic symptoms are only associated with branch events;
  • Severe stenosis or occlusion of tandem extracranial or intracranial vessels at the proximal or distal end of the target vessel;
  • Angioplasty or stenting procedures is planned for extracranial vascular lesions with tandem intracranial vessels;
  • History of endarterectomy in the extracranial segment of carotid artery and vertebral artery within 30 days;
  • The target vessel has previously been treated with stenting or angioplasty or other mechanical devices (applicable to Sub-study A only); the target vessel previously treated with drug-coated balloon expansion (applicable only to Sub-study B);
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  • Acute or subacute intraluminal thrombosis is found in the target vessel;
  • Imaging shows an infarct size > 1/2 of the target vessel's supply area;
  • Patients with intracranial stenosis combined with aneurysm, intracranial tumor or intracranial vascular malformation, or intracranial arterial spasm without significant stenosis;
  • Intracranial hemorrhage (cerebral intraparenchymal hemorrhage, massive subarachnoid hemorrhage, and subdural/epidural hemorrhage) within 3 months;
  • Acute or subacute ischemic stroke occurring within 2 weeks;
  • Non-atherosclerotic stenosis, such as arterial dissection, Moyamoya disease, vasculitis, radiation-induced vasculopathy, or fibromuscular dysplasia;
  • There are cardiogenic stroke or risk factors that may contribute to cardioembolism, such as fibrillation, left ventricular thrombosis or myocardial infarction within 6 weeks,;
  • Patients with abnormal coagulation function or bleeding tendency (e.g., international normalized ratio (INR) > 1.5);
  • Patients with known hypersensitivity to iodine contrast medium, paclitaxel, or iopromide;
  • Any of the following abnormal laboratory test results within 7 days prior to the interventional procedure:
  • White blood cell (WBC) count < 3 × 10^9/L
  • Neutrophil count < 1.0 × 10^9/L
  • Platelet count < 100 × 10^9/L
  • ALT or AST > 3 × upper limit of normal (ULN)
  • Serum creatinine > 3.0 mg/dL;
  • Lactating females, or females of childbearing potential with a positive serum pregnancy test result;
  • The investigator judges that the patient has a severe medical condition that may affect protocol compliance (e.g., severe infection, severe chronic obstructive pulmonary disease [COPD], malignant tumor, dementia, psychiatric illness, or uncontrolled severe hypertension, defined as systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg, etc.);
  • Patients who are participating in clinical trials of other drugs or devices;
  • Blood flow-limiting dissection or residual stenosis > 50% after pre-dilation；
  • Other conditions that the investigator deems the patient unsuitable for enrollment.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

  • The First Hospital of Jilin University

    Changchun, Jilin

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Jining First People's Hospital

    Jining, Shandong

  • Nanyang Central Hospital

    Nanyang, Henan

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • Renji Hospital, Shanghai Jiaotong University, School of Medicine

    Shanghai, Shanghai Municipality

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

Other trials in China

About this study

Official title: A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the Intracranial Paclitaxel Drug-eluting Balloon Catheters (SeQuent® Please CIS) in the Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis and Restenosis After Interventional Therapy

This study is aiming to evaluate the safety and efficacy of SeQuent® Please CIS in the endovascular treatment of symptomatic intracranial atherosclerotic stenosis and restenosis after interventional therapy.

Read the detailed description

This study includes 2 sub-studies, sub-study A and sub-study B, namely.

Sub-study A is a prospective, multicenter, randomized controlled, superior clinical trial to evaluate the safety and effectiveness of paclitaxel drug-releasing intracranial balloon catheter (SeQuent® Please CIS) in the treatment of symptomatic intracranial atherosclerotic stenosis.

Sub-study B is a prospective, multicenter, single-arm clinical trial designed to evaluate the safety and efficacy of paclitaxel drug-releasing intracranial balloon catheter (SeQuent® Please CIS) for the treatment of restenosis following interventional treatment for symptomatic intracranial atherosclerotic stenosis.

A total of 277 subjects are expected to be enrolled, including 252 subjects in sub-study A and 25 subjects in sub-study B. Subjects enrolled in sub-study A will be randomized into the study arm and the control arm with the ratio of 1:1. The study arm will be treated with SeQuent® Please CIS (paclitaxel drug-releasing intracranial balloon catheter), while the control arm will be treated with intracranial PTA balloon catheter. Subjects enrolled in sub-study B will all be treated with SeQuent®, Please CIS.

All subjects will be followed up till 12 month post procedure.

Being tested
DCB, POBA
Keywords
symptomatic intracranial atherosclerotic stenosis, DCB
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DCBDevice

    Intracranial paclitaxel drug-eluting balloon catheters (SeQuent® Please CIS)

  • POBADevice

    Intracranial PTA balloon catheter

Study groups in NCT06047964
Study groupRoleWhat they receive
Sub-study A: De-novo DCB groupExperimentalPatients with de-novo symptomatic intracranial atherosclerotic stenosis and treated with DCB
Receives: Device: DCB
Sub-study A: De-novo POBA groupActive comparatorPatients with de-novo symptomatic intracranial atherosclerotic stenosis and treated with POBA
Receives: Device: POBA
Sub-study B: Restenosis groupExperimentalPatients with symptomatic intracranial atherosclerotic re-stenosis after interventional therapy and treated with DCB
Receives: Device: DCB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. restenosis incidence of target lesion

    angiographic restenosis measured by WASID ( Warfarin-Aspirin Symptomatic Intracranial Disease) method in core-lab

    Measured: 6 months post-procedure

Secondary outcomes (6)

  1. Device success rate

    Successful delivery, dilatation and withdraw of the balloon

    Measured: baseline procedure

  2. The changes of Modified Rankin Scale(mRS) score

    Scores range from 0 to 6, with higher scores indicating more severe nerve damage; Change of mRS score = mRS score at 6 months (12 months) after surgery - mRS score at baseline

    Measured: 6 and 12 months post-procedure

  3. The changes of NIH Stroke Scale(NIHSS) score

    Scores range from 0 to 42, with higher scores indicating more severe nerve damage; Change of NIHSS score = NIHSS score at 6 months (12 months) after surgery - NIHSS score at baseline.

    Measured: 6 and 12 months post-procedure

  4. Number and incidence (%) of target vessel stroke events (including ischemic or hemorrhagic stroke), transient ischemic attack

    Incidence of target vessel stroke events (%) = (number of subjects with target vessel stroke events/total number of subjects) × 100%.

    Incidence of transient ischemic attacks (%) = (number of subjects with transient ischemic attacks/total number of subjects) × 100%.

    Measured: 6 and 12 months post-procedure

  5. Recurrence incidence of ipsilateral ischemic stroke

    Recurrence incidence of ipsilateral ischemic stroke (%) = (number of subjects with recurrent ipsilateral ischemic stroke/total number of subjects) × 100%.

    Measured: 30 days, 6 and 12 months post-procedure

  6. restenosis incidence of target lesion

    angiographic restenosis measured by WASID ( Warfarin-Aspirin Symptomatic Intracranial Disease) method in core-lab

    Measured: ≥12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start23 Mar 2023
  3. Primary completion29 Sep 2024
  4. Study completion30 Sep 2026 (estimated)

Resources

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
None (open label)
Enrolment
281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06047964
Sponsor's protocol ID
SPINAS
Acronym
SPINAS
Status last verified
Jun 2026
First submitted
30 Aug 2023
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing DCB and POBA in people with Stroke and Intracranial Atherosclerotic Stenosis, run by B. Braun Medical International Trading Company Ltd. at 9 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 9 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

This study is still under way. Results are not available in the source record yet.

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 incidence of target lesion (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06047964.

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 12 Jun 2026.

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SPINAS Clinical Trial NCT06047964 | AzTrials