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Enrolling by invitation NCT06683118

Registration Trial of the Drug-coated Balloon for the Symptomatic Cerebral Atherosclerotic Stenosis

No phase Interventional Cerebral Atherosclerotic Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rapamycin neurovascular Balloon Catheter, Conventional Balloon.
Who it may be relevant to
Registry conditions: Cerebral Atherosclerotic Stenosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SUPERIORITY, RANDOMIZED, CONTROLLED REGISTRATION TRIAL OF THE RAPAMYCIN NEUROVASCULAR BALLOON CATHETER FOR THE TREATMENT OF SYMPTOMATIC CEREBRAL ATHEROSCLEROTIC STENOSIS

Overview

The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis

Interventions

  • Device Rapamycin neurovascular Balloon Catheter
    Drug-coated balloon for the symptomatic cerebral atherosclerotic stenosis
  • Device Conventional Balloon
    Conventional Balloon for the symptomatic cerebral atherosclerotic stenosis

Primary outcome measures

  • Target lesion restenosis rate at 6 month postoperative [Time frame: 180±30days]
Secondary outcome measures (7)
  • Technical succeed rate [Time frame: Intraoperation]
  • Target vascular-related stroke or death at 30 days postoperatively [Time frame: 30±7days]
  • Any stroke or death at 30 days postoperatively [Time frame: 30±7days]
  • Target vascular-related stroke or death at 6 month postoperatively [Time frame: 180±30days]
  • Any stroke or death at 6 month postoperatively [Time frame: 180±30days]
  • Target vascular-related stroke or death at 12 month postoperatively [Time frame: 360±60days]
  • Any stroke or death at 12 month postoperatively [Time frame: 360±60days]

Eligibility criteria

Incsion Criteria:

  • Age 18 to 80 years old at informed consent signing.
  • Symptomatic atherosclerotic stenosis of cerebrovascular arteries with ≥70% stenosis.
  • Medication ineffective.
  • modified Rankin Scale(mRS) score≤2.
  • The subject or guardian is able to understand the purpose of the study, is willing to participate and has given written informed consent.

Exclusion criteria

  • History of acute ischemic stroke within 2 weeks;
  • Stenosis due to non-atherosclerotic lesions such as arterial dissection, Moya-Moya disease and vasculitic disease;
  • Target vessels complete occlusion or with thrombus in target vessels;
  • Target vessel with severe calcification or distortion that making interventional device is difficult to place;
  • History of stenting in the target artery;
  • Target vessel restenosis following stenting or balloon angioplasty;
  • Combined with other lesion with ≥70% stenosis in target vessel.
  • Residual stenosis ≥50% or vessel dissection with obvious blood flow restriction occurs after predilation.
  • Combined with intracranial tumour, arteriovenous malformation or aneurysm of the target vessel.
  • History of intracranial hemorrhage within 90days.
  • Presence of severe systemic diseases that cannot tolerate surgery, such as severe liver and kidney dysfunction;
  • Contraindication to the use of anticoagulants and antiplatelet agents, such as sllergy to anticoagulants and antiplatelet agents, active bleeding or coagulation disorders;
  • Allergic to contrast agents or rapamycin;
  • Pregnant or lactating women;
  • Participating or intending to participate in any other drug/device clinical trials;
  • Life expectancy <1 year;
  • Any other conditions that the investigator deems the patient unsuitable for enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Tiantan Hospital Affiliated of Peking University — Beijing
  • Huashan Hospital Affiliated of Fudan University — Shanghai

Identifiers

NCT: NCT06683118 · JUJI-2023-01-CIP-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗