Standardized Procedure for Intracranial Drug-Eluting Stenting in the Treatment of Intracranial Atherosclerotic Stenosis

March 26, 2025 updated by: Sino Medical Sciences Technology Inc.

A Prospective, Multicenter, Registry Study to Evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis

The primary objective of this trial is to evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigation is a prospective, multi-center clinical study. The trial is expected to enroll 300 subjects. The population for this study is subjects with intracranial atherosclerotic stenosis who are suitable candidates for stent angioplasty. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after they signed the informed consent form. The study consists of ten visits including preoperative screening, procedure date, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years. The primary endpoints are stroke or death within 30 days after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Zhengzhou, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Sheng Guan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males or females between 18 and 80 years of age
  2. Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm
  3. Intracranial artery stenosis ( ≥70%) conformed by DSA
  4. Those who voluntarily participate in the study and sign informed consent form

Exclusion Criteria:

  1. Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above);
  2. Subjects of acute hemorrhagic stroke within 3 months;
  3. The baseline mRS of disabling stroke is more than 3;
  4. The target vessel is severely calcified and closely related to stenosis;
  5. Non-atherosclerotic diseases (e.g. arterial dissection, Moya Moya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm);
  6. It is suspected that the ischemic event is due to embolism or arterial embolism from the extracranial segment (including ipsilateral chest or neck vascular occlusive disease) or potential cardiogenic embolism (e.g. atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.);
  7. The presence of a >50% stenosis in the main blood supply artery of the target vessel. For example, when the lesion is located in the middle cerebral artery, the ipsilateral internal carotid artery stenosis by over 50% should be excluded; when the lesion is located in the basilar artery, the dominant side vertebral artery stenosis >50% should be excluded;
  8. There are intracranial tumors, or intracranial arteriovenous malformations;
  9. Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and stent components;
  10. Pregnant and lactating women
  11. Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders;
  12. Inapplicable for this study at the investigators' viewpoints.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NOVA DES
Patients who met the inclusion criteria were implanted with the NOVA stent, and the procedure was documented in detail.
Device: NOVA DES
The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stroke or death within 30 days after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure.
Time Frame: 1 year after procedure
This outcome includes ischemic/hemorrhagic stroke and all-cause death within 30 days after procedure of the qualifying lesion during follow-up, or any ischemic stroke and revascularization from the original culprit symptomatic intracranial artery beyond 30 days through 12 months after procedure.
1 year after procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Device defect
Time Frame: within 5 years of whole trial
Device defects refer to the unreasonable risks that may endanger human health and life safety during the normal use of medical devices in the course of clinical trials, such as label errors, quality problems, failures, etc.
within 5 years of whole trial
Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after procedure
Time Frame: 30 days after procedure
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the target blood supply area
30 days after procedure
Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after procedure
Time Frame: 30 days after procedure
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the non-target blood supply area
30 days after procedure
Rate of TIA at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Time Frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
TIA is a temporary blockage of blood flow to the brain with symptoms last from only a few minutes up to 24 hours
30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Time Frame: 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the target blood supply area
3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Time Frame: 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the non-target blood supply area
3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Rate of death (vascular/ non-vascular death) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Time Frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
The cause of death was classified as vascular or nonvascular and based on information obtained from the family, medical records, and death certificates. Vascular death included death due to stroke, MI, heart failure, pulmonary embolus, cardiac arrhythmia, or other vascular cause.
30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Rate of symptomatic ISR and Revascularization at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Time Frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
symptomatic ISR is defined as ISR associated with an ischemic event in the territory. Revascularization is the restoration or improvement of blood supply, and included surgical operation, endovascular procedures, etc.
30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Rate of modified Rankin Scale (mRS) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Time Frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
EQ-5D score at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Time Frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
A health state defined by the descriptive EQ-5D system can be described by a five-digit number, each digit indicating the score of the corresponding dimension.
30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Rate of in-stent restenosis at 1, 2, 3, 4 years and 5 years after procedure (Optional)
Time Frame: 1, 2, 3, 4 years and 5 years after procedure
Patients with ≥50% stenosis of the vessel
1, 2, 3, 4 years and 5 years after procedure
Rate of bleeding events at 1 years after procedure
Time Frame: 1 year after procedure
Bleeding was defined according to Bleeding Academic Research Consortium
1 year after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sino Medical Sciences Technology Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tongji Hospital
The First Affiliated Hospital of Zhengzhou University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sheng Guan, The First Affiliated Hospital of Zhengzhou University
  • Principal Investigator: Chun Fang, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 8, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SN-NOVA II SOP-202501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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