Health TrialsbyHealthPanel

Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

ConditionIntracranial Atherosclerotic Stenosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBochang

About this trial

This test took the target lesion restenosis rate 6 months after the operation as the main endpoint to verify the effectiveness of the intracranial balloon expansion catheter of Biolimus coating. After completing the follow-up 6 months after the operation, a clinical summary report was issued for the registration application of the product, and on this basis, 12 months of postoperative follow-up was carried out to evaluate the mid-term curative effect.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 to 80 years old;

Symptomatic intracranial artery stenosis, and the degree of visual stenosis of target blood vessels under intracranial angiography is 70~99%(WASID method);

Disqualifiers

Target blood vessels are seriously calcified and distorted, and it is difficult to put the interventional instruments in place or recover;

Ischemic cerebral infarction occurred 3 weeks before surgery;

Cerebral hemorrhage 3 months before operation;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Drug balloon dilated

    Device

    Through the expansion after the balloon is in place,Release drugs on the surface of the balloon and improve the blood perfusion of nerve vessels to treat stenosis

  • balloon dilated

    Device

    Through the expansion after the balloon is in place, improve the blood perfusion of nerve vessels to treat stenosis.

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-month target lesion restenosis rate

Time frame
6-month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bochang

Lead sponsor

Xuanwu Hospital, Beijing

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

First People's Hospital of Hangzhou

Collaborator

Jinan Central Hospital

Collaborator

The Affiliated Hospital of Qingdao University

Collaborator

Beijing Geriatric Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: