Safety and Efficacy of Spinous Balloon Dilatation Catheter in CAD Treatment
A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Spinous Balloon Dilatation Catheter (Plastic-BladeTM) in the Treatment of Coronary Artery Disease
1 other identifier
interventional
160
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of spinous process balloon dilation catheter (Plastic-Blade) in coronary vascular diseases, which is not inferior to the similar product on the market - coronary spinous process balloon dilation catheter (lacrosse NSE) produced by Goodman Co., Ltd..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started May 2022
Shorter than P25 for not_applicable coronary-artery-disease
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
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedStudy Start
First participant enrolled
May 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 25, 2022
March 1, 2022
8 months
March 15, 2022
April 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Immediate lumen acquisition
The difference of the minimum diameter of the target lesion before and after balloon dilatation in the test or control group measured by QCA.
during the procedure
Secondary Outcomes (8)
Rate of device success
during the procedure
Rate of clinical success
from procedure to discharge ( to the 7th day after procedure)
Incidence of related complications
30 days after balloon dilatation
% change of clinically meaningful laboratory tests
30 days after procedure
Number of adverse events
30 days
- +3 more secondary outcomes
Study Arms (2)
spinous balloon dilatation catheter(Plastic-Blade)
EXPERIMENTALPatients with CAD will be treated with spinous balloon dilatation catheter(Plastic-Blade).
spinous balloon dilatation catheter(lacrosse NSE)
EXPERIMENTALPatients with CAD will be treated with spinous balloon dilatation catheter(lacrosse NSE)
Interventions
To treat Coronary artery disease
To treat Coronary artery disease
Eligibility Criteria
You may qualify if:
- \. 18-75 years
- Stable or unstable angina, or previous myocardial infarction, or Asymptomatic ischemia judged by clinician ,Target vascular diameter: 2.00-4.00mm ,Coronary artery stenosis stenosis ≥ 70% by visual inspection, or ≥ 50% with evidence of ischemia, TIMI blood flow≥ 1,the operator judge that the patient needs spinous balloon to treat.
- \. Paticipant can understand the study ,voluntarily participate in and sign the informed consent form,and accept scheduled follow-up.
You may not qualify if:
- Patient related:
- Pregnant and breast-feeding women or intention to be pregnant.
- Subjects with MI within one week, or more than one week after the onset of MI,but TNI or TNT have not returned to normal.
- The spinous balloon failed to pass through the stenosis after small balloon dilation , and the lesion need to be rotary grinded.
- \. Non-target vessel did not be dealed with successful before dealing with target vessel, or non-target vascular lesion number is more than three.
- Serious heart failure（NYHA IV）
- Severe renal failure（Cr\>443uMol/L) or patients undergoing hemodialysis.
- Patient with heart transplant.
- Patient with CABG.
- Patients with hemodynamic instability or shock symptoms.
- Life expectancy less than one year.
- Expected to undergo surgery within one month.
- Patients with bleeding tendency, history of active gastrointestinal ulcer, contraindications of antiplatelet or anticoagulant treatment, cannot receive anticoagulant treatment, and patients have hemorrhagic stroke within six months.
- Allergy to heparin and contrast agent.
- The illness of the patient make the treatment and evaluation difficult.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CCRF Inc., Beijing, Chinalead
- Shanghai 10th People's Hospitalcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yawei Xu, MD.,Ph D.
Department of Cardiology, Shanghai Tenth People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- During the study, it is difficult for researchers, operators and patients to blind the method due to objective reasons.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2022
First Posted
April 25, 2022
Study Start
May 16, 2022
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
April 25, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share