Back to resultsCompare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease
Primary Purpose
Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SINOMED CBC
NSE Coronary Dilatation Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Stenosis focused on measuring Coronary dilation catheter, Percutaneous coronary artery dilatation, Restenosis, Cutting balloon catheter, scoring balloon catheter
Eligibility Criteria
Inclusion Criteria:
- The patient is at least 18 to 75 years of age, male or not pregnant female.
- Evidence of myocardial ischemia without symptoms, stable or unstable angina, silent ischemia demonstrated by positive territorial functional study, or old myocardial infarction.
- De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis.
- Reference vessel diameter (RVD) must be visually estimated ≥ 2.5 and ≤ 5.0mm, and the vessel length must be no more than 30mm.
- Target lesion(s) must have a diameter stenosis of (a) ≥70% by visual estimation or (b) >50% with evidence of ischemia.
- The patient has a planned intervention at no more than two de novo lesions, in different epicardial vessels.
- Investigators believe that target lesion atherosclerotic plaques require spinous balloon treatment and balloon can be passed through by pre-dilation.
- Able to understand the purpose of the trial, voluntarily participate and sign the informed consent.
Exclusion Criteria:
- Evidence of ongoing acute myocardial infarction within a week.
- Chronic total occlusion (TIMI 0), left main lesion, intervention-required three-vessel lesions, and bypass lesion.
- Severe calcification and Target lesion in a severe angulation (> 45 degrees).
- Patient has serious heart failure symptoms (NYHA level III or IV), or Left ventricular ejection fraction (LVEF) <40%.
- Patient with renal dysfunction, as Cr>176.82umol/L or Cr >2.0 mg/dl.
- Patient with active gastrointestinal bleeding history, any other evidence based bleeding, such as suspected liver failure disease, suffered from cerebral bleeding history, stroke during the last 6 months, with contra-indication of anti-platelet or anti-coagulation.
- Patients with allergies to heparin and contrast media.
- Target lesion demonstrating severe dissection prior to planned deployment of the trial device.
- Visible thrombus at the target lesion.
- Patients received heart transplantation.
- Participation in another clinical trial (12 months after index procedure).
- Those who participated in another clinical trials, but did not reach the primary endpoint.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SINOMED CBC
NSE Coronary Dilatation Catheter
Arm Description
Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)
Outcomes
Primary Outcome Measures
Rate of Device procedural success (lesion level)
Defined as: Successful delivery, inflation, deflation, and withdrawal of the study balloon; and ≤30% final diameter stenosis following completion of the interventional procedure, including adjunctive stenting (For ISR or DCB related stenosis, Final diameter stenosis<50%)
Secondary Outcome Measures
Rate of Procedural success (patient level)
Defined as: ≤30% final diameter stenosis following completion of the interventional procedure, including adjunctive stenting (For ISR or DCB related stenosis, Final diameter stenosis<50%); and freedom from major adverse cardiac events (MACE) during hospitalization
Rate of Target lesion failure (TLF)
a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (CI-TLR)
Rate of Patient-oriented composite endpoint (POCE)
a composite of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization
Incidence of any AE and SAE incidence
report any AE results from a device deficiency or other device issue as related to the use of the study device. Such as Balloon burst、vascular perforation, dissection, acute occlusion, vasospasm, thrombosis (including stent thrombosis), arrhythmia requiring intervention, and so on.
Rate of device defect
report any device defect during hospitalization
Full Information
NCT ID
NCT05509296
First Posted
August 16, 2022
Last Updated
August 22, 2022
Sponsor
Sino Medical Sciences Technology Inc.
Collaborators
Peking University First Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05509296
Brief Title
Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease
Official Title
A Prospective, Multicenter, Randomized Control, Non-inferiority to Investigate the Effectiveness and Safety of SINOMED CBC for Endovascular Treatment of Stenotic Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 23, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
January 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sino Medical Sciences Technology Inc.
Collaborators
Peking University First Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
Detailed Description
The investigation is a prospective, multi-center, randomized control, non-inferiority clinical study. The study will be conducted in up to 8 investigational sites in the China This study will enroll and treat 136 subjects, including in-stent restenosis (ISR). The population for this study is subjects with stenotic coronary artery disease who are suitable candidates for PTCA.
After screening for initial inclusion and exclusion criteria, eligible subjects will be asked to participate in the study by signing a consent form. Following consent, subjects will undergo a baseline visit where eligibility criteria will be assessed. Then, subjects will be randomized to either trial balloon (Sino Medical Sciences Technology Inc. ) or to a NSE Coronary Dilatation Catheter (Goodman Co.,Ltd). Angiograms will be performed before and after intervention.
Subjects will be followed through hospital discharge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
Keywords
Coronary dilation catheter, Percutaneous coronary artery dilatation, Restenosis, Cutting balloon catheter, scoring balloon catheter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, multicenter, randomized control,non-inferiority clinical study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SINOMED CBC
Arm Type
Experimental
Arm Description
Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
Arm Title
NSE Coronary Dilatation Catheter
Arm Type
Active Comparator
Arm Description
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)
Intervention Type
Device
Intervention Name(s)
SINOMED CBC
Other Intervention Name(s)
cutting balloon catheter, scoring balloon catheter
Intervention Description
The Coronary Dilatation Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.
Intervention Type
Device
Intervention Name(s)
NSE Coronary Dilatation Catheter
Other Intervention Name(s)
Lacrosse NSE
Intervention Description
The Coronary Dilatation Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.
Primary Outcome Measure Information:
Title
Rate of Device procedural success (lesion level)
Description
Defined as: Successful delivery, inflation, deflation, and withdrawal of the study balloon; and ≤30% final diameter stenosis following completion of the interventional procedure, including adjunctive stenting (For ISR or DCB related stenosis, Final diameter stenosis<50%)
Time Frame
immediate post-intervention(approximately 1.4 hour)
Secondary Outcome Measure Information:
Title
Rate of Procedural success (patient level)
Description
Defined as: ≤30% final diameter stenosis following completion of the interventional procedure, including adjunctive stenting (For ISR or DCB related stenosis, Final diameter stenosis<50%); and freedom from major adverse cardiac events (MACE) during hospitalization
Time Frame
during the hospital stay, an average of 7 days post-procedure
Title
Rate of Target lesion failure (TLF)
Description
a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (CI-TLR)
Time Frame
during the hospital stay, an average of 7 days post-procedure
Title
Rate of Patient-oriented composite endpoint (POCE)
Description
a composite of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization
Time Frame
during the hospital stay, an average of 7 days post-procedure
Title
Incidence of any AE and SAE incidence
Description
report any AE results from a device deficiency or other device issue as related to the use of the study device. Such as Balloon burst、vascular perforation, dissection, acute occlusion, vasospasm, thrombosis (including stent thrombosis), arrhythmia requiring intervention, and so on.
Time Frame
during the hospital stay, an average of 7 days post-procedure
Title
Rate of device defect
Description
report any device defect during hospitalization
Time Frame
during the hospital stay, an average of 7 days post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient is at least 18 to 75 years of age, male or not pregnant female.
Evidence of myocardial ischemia without symptoms, stable or unstable angina, silent ischemia demonstrated by positive territorial functional study, or old myocardial infarction.
De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis.
Reference vessel diameter (RVD) must be visually estimated ≥ 2.5 and ≤ 5.0mm, and the vessel length must be no more than 30mm.
Target lesion(s) must have a diameter stenosis of (a) ≥70% by visual estimation or (b) >50% with evidence of ischemia.
The patient has a planned intervention at no more than two de novo lesions, in different epicardial vessels.
Investigators believe that target lesion atherosclerotic plaques require spinous balloon treatment and balloon can be passed through by pre-dilation.
Able to understand the purpose of the trial, voluntarily participate and sign the informed consent.
Exclusion Criteria:
Evidence of ongoing acute myocardial infarction within a week.
Chronic total occlusion (TIMI 0), left main lesion, intervention-required three-vessel lesions, and bypass lesion.
Severe calcification and Target lesion in a severe angulation (> 45 degrees).
Patient has serious heart failure symptoms (NYHA level III or IV), or Left ventricular ejection fraction (LVEF) <40%.
Patient with renal dysfunction, as Cr>176.82umol/L or Cr >2.0 mg/dl.
Patient with active gastrointestinal bleeding history, any other evidence based bleeding, such as suspected liver failure disease, suffered from cerebral bleeding history, stroke during the last 6 months, with contra-indication of anti-platelet or anti-coagulation.
Patients with allergies to heparin and contrast media.
Target lesion demonstrating severe dissection prior to planned deployment of the trial device.
Visible thrombus at the target lesion.
Patients received heart transplantation.
Participation in another clinical trial (12 months after index procedure).
Those who participated in another clinical trials, but did not reach the primary endpoint.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyan Yu
Phone
18614030565
Email
yuxiaoyan@sinomed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jianping li, M.D/Ph.D
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease
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