IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)

NCT05974033 | Not Yet Recruiting DMC

• 1 other identifier: ICAS-MT
• Study Type: interventional
• Target: 536
• Locations: 0 countries
• Sites: N/A

Brief Summary

A multicenter, open-label, blinded-endpoint, prospective, randomized controlled clinical trial with an "all comers" design.

Conditions

ICAS - Intracranial Atherosclerosis

Keywords

ICAS; Cerebral Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

• Stroke or death

  Stroke or death within 30 days after enrollment; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 30 days and 1 year.

  Stroke or death within 30 days after enrollment; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 30 days and 1 year.

Secondary Outcomes (7)

• Ischemic stroke in the target vessel territory

  Within 1-3 years after enrollment

• Ischemic stroke in non-target vessel territory

  Within 30 days to 1 year, and within 1-3 years after enrollment

• Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage

  Within 30 days to 3 years after enrollment

• Any cause of death

  Within 30 days to 3 years after enrollment

• mRS score

  At 1 year, 2 years, and 3 years after enrollment

Study Arms (2)

Intervention group

EXPERIMENTAL

Stenting plus medical therapy

Combination Product: Stenting plus medical therapy

Control group

ACTIVE COMPARATOR

Medical therapy alone

Drug: Medical therapy alone

Interventions

Stenting plus medical therapy COMBINATION_PRODUCT

Patients randomized to intervention group received the percutaneous transluminal balloon angioplasty with stenting within 5 days after randomization, and loading dose of aspirin and clopidogrel was allowed. Received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after procedure.

Intervention group

Medical therapy alone DRUG

Medical therapy alone: received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after randomisation.

Control group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥30 and ≤80 years old.
• Symptomatic intracranial atherosclerotic stenosis: Transient ischemic attack (TIA) or stroke related to 70%-99% stenosis in the major intracranial arteries (intracranial segment of the internal carotid artery, M1 segment of the middle cerebral artery, V4 segment of the vertebral artery, and basilar artery) within the past 3 months.
• Only one target vessel with 70-99% stenosis confirmed by angiography for enrollment in the trial (WASID criteria).
• Patients with ischemic stroke should be performed with stenting beyond a duration of 2 weeks from the latest ischemic symptom onset, patients with TIA have no time restriction.
• Pre-enrollment modified Rankin Scale (mRS) score ≤2.
• Target vessel reference diameter must be measured to be 2 mm to 4.5 mm, target area of stenosis is less than or equal to 14mm in length.
• Patients required to meet at least with one atherosclerotic risk factors, including hypertension, diabetes, hyperlipidemia, hyperhomocysteinemia, coronary heart disease, obesity, smoking history, and atherosclerosis in other arterial vessels.
• Negative pregnancy test in a female who has had any menses in the last 18 months.
• Patient is willing and able to return for all follow-up visits required by the protocol.
• Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent.

You may not qualify if:

• Intracranial arterial stenosis not caused by atherosclerotic lesions, such as arterial dissection, moya-moya disease, vasculitic disease, viral vascular lesions (e.g., herpes zoster, varicella), neurosyphilis, other intracranial infections, radiation-induced vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, benign central nervous system vascular diseases, postpartum angiopathy, suspected vasospastic process, suspected recanalized embolus, etc.
• Any conditions that precludes proper angiographic assessment.
• Preoperative MRI indicating only lacunar infarction in the target lesion territory.
• History of subarachnoid hemorrhage, subdural or epidural hematoma within 30 days prior to enrollment, or untreated chronic subdural hematoma thickness≥5mm, or history of primary intracerebral hemorrhage.
• At risk of hemorrhagic transformation during the procedure (CT or MRI showing infarct area diameter \>5 cm); hemorrhagic transformation of an ischemic stroke within the past 15 days (detected by CT).
• Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion
• Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which lesion is symptomatic (for example, if patient has pon, midbrain, temporal and occipital symptoms).
• Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date.
• Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform staged angioplasty followed by stenting of target lesion
• Severe vascular tortuosity, severe calcification, or other factors that would preclude the safe introduction of a guiding catheter, guiding sheath or stent placement.
• Presence of intraluminal thrombus proximal to or at the target lesion.
• Any aneurysm proximal to or distal to intracranial stenotic artery.
• Intracranial tumors or any intracranial vascular malformations.
• Potential cardiac sources of emboli such as atrial fibrillation, left ventricular thrombus, heart valve replacement, atrial septal defect, ventricular septal defect, atrial myxoma, etc.
• Myocardial infarction within previous 30 days.

Sponsors & Collaborators

• Changhai Hospital: lead

MeSH Terms

Conditions

Intracranial Arteriosclerosis

Interventions

Stents

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Jianimin Liu, M.D.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengfei Yang, M.D.

CONTACT

86-21-31161784; 15921196312@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 3, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• Access Criteria: 1. The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. 2. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. 3. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. 4. Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. 5. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses