Registration Trial of the Drug-coated Balloon for the Symptomatic Cerebral Atherosclerotic Stenosis (NCT06683118) | Clinical Trial Compass
By InvitationNot Applicable
Registration Trial of the Drug-coated Balloon for the Symptomatic Cerebral Atherosclerotic Stenosis
China212 participantsStarted 2024-05-27
Plain-language summary
The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ra…
What they're measuring
1
Target lesion restenosis rate at 6 month postoperative