A Single-Arm Trial of Neurovascular Drug-Eluting Balloon Dilatation Catheter Treating Symptomatic Intracranial Atherosclerotic Stenosis
The Efficacy and Safety Study for Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis Using Neurovascular Drug-Eluting Balloon Dilatation Catheter: A Prospective Multicentre Single-arm Trial
1 other identifier
interventional
132
1 country
11
Brief Summary
This is a trial designed to test the efficacy and safety of the Neurovascular Drug-Eluting Balloon Dilatation Catheter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2021
CompletedFirst Posted
Study publicly available on registry
July 2, 2021
CompletedStudy Start
First participant enrolled
November 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedOctober 17, 2022
October 1, 2022
1.5 years
June 24, 2021
October 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Restenosis rate of the target lesion
Subjects receive Digital Subtraction Angiography (DSA) / Computed Tomography Angiography (CTA) examination in 180 days to analyze whether the degree of stenosis is greater than or equal to 50%, if so, the target lesion restenosis happens.
180+60 days
Secondary Outcomes (3)
Average stenosis degree of the target lesion
180+60 days
Success rate of device
Intraoperation
Success rate of surgery
Intraoperation
Other Outcomes (5)
Incidence of device deficiency
within 180+60 days
Incidence of stroke events
7 days or at discharge / 30±7 days / 180+60 days
Rate of death
7 days or at discharge / 30±7 days / 180+60 days
- +2 more other outcomes
Study Arms (1)
Group A
EXPERIMENTALNeurovascular Drug-Eluting Balloon Dilatation Catheter
Interventions
The neurovascular drug-eluting balloon dilatation catheter consists of a tip, a drug-coated balloon, markers, a catheter and a catheter hub. The main component of the drug coating is sirolimus, and the coating is evenly distributed on the effective length surface of the balloon.
Eligibility Criteria
You may qualify if:
- Age 18 to 80 years, any gender;
- Subject has symptomatic intracranial atherosclerotic stenosis that the degree of the artery stenosis is between 70% and 99% diagnosed by intracranial angiography;
- The target stenotic artery locates in Internal Carotid Artery (intracranial segment), Middle Cerebral Artery (M1, M2), Basilar Artery, Vertebral Artery (intracranial segment);
- Intracranial artery stenosis requiring interventional treatment is a single lesion;
- Subject has at least two atherosclerosis risk factors including history or present hypertension, diabetes, hyperlipidemia, smoking, age\>45;
- modified Rankin Scale(mRS) score≤2 before enrollment;
- Subject or guardian is able to understand the purpose of study, agree to provide follow-up data and has provided written informed consent.
You may not qualify if:
- History of acute ischemic stroke within 2 weeks;
- History of intracranial hemorrhage (including intraparenchymal hemorrhage, subarachnoid hemorrhage, subdural hemorrhage and epidural hemorrhage) within 3 months;
- Hypertension uncontrolled by medicine (Systolic pressure≥180 mmHg or diastolic pressure≥110 mmHg continuously);
- Combined with the intracranial tumor, aneurysm or intracranial arteriovenous malformation;
- The length of intracranial artery stenosis \>10mm and extremely angulated \>90°, which indicated by angiography;
- History of stent intervention within the target lesion;
- Allergic to heparin, sirolimus (i.e. rapamycin), contrast agents, aspirin, clopidogrel, anesthetics;
- History of gastrointestinal hemorrhage within 6 months before signing the informed consent form, which is unable to receive antiplatelet therapy;
- Platelet (PLT)\<90\*10\^9/L;
- Creatinine\>250 umol/L;
- International Normalized Ratio (INR)\>1.5;
- Female subject who is pregnant or breast-feeding, or who has a pregnancy plan within 12 months;
- Expected life \<12 months;
- Unable to cooperate with or tolerate the interventional surgery;
- Subject who has participated in other drug or device clinical trials or hasn't reached the primary end point;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
The First Affiliated Hospital of USTC
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Cangzhou Central hospital
Cangzhou, Hebei, China
Wuhan Hospital of Traditional Chinese and Western Medicine
Wuhan, Hubei, China
General Hospital of Northen Theater Command
Shenyang, Liaoning, China
Linyi People's Hospital
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
Xuanwu Hospital Capital Medical University
Beijing, China
Changhai Hospital of Shanghai
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianmin Liu
Changhai Hospital
- PRINCIPAL INVESTIGATOR
Liqun Jiao
Xuanwu Hospital, Beijing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2021
First Posted
July 2, 2021
Study Start
November 2, 2021
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
October 17, 2022
Record last verified: 2022-10