Coronary Artery Stenosis, Coronary Stenosis, In-stent Restenosis
Conditions
Keywords
Coronary dilation catheter, Percutaneous coronary artery dilatation, Restenosis, Cutting balloon catheter, scoring balloon catheter
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.
Interventions
DEVICESINOMED CBC
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.
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.
Sponsors
Sino Medical Sciences Technology Inc.
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, multicenter, randomized control,non-inferiority clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The patient is at least 18 to 75 years of age, male or not pregnant female. 2. Evidence of myocardial ischemia without symptoms, stable or unstable angina, silent ischemia demonstrated by positive territorial functional study, or old myocardial infarction. 3. De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis. 4. Reference vessel diameter (RVD) must be visually estimated ≥ 2.5 and ≤ 5.0mm, and the vessel length must be no more than 30mm. 5. Target lesion(s) must have a diameter stenosis of (a) ≥70% by visual estimation or (b) \>50% with evidence of ischemia. 6. The patient has a planned intervention at no more than two de novo lesions, in different epicardial vessels. 7. Investigators believe that target lesion atherosclerotic plaques require spinous balloon treatment and balloon can be passed through by pre-dilation. 8. Able to understand the purpose of the trial, voluntarily participate and sign the informed consent.
Exclusion criteria
1. Evidence of ongoing acute myocardial infarction within a week. 2. Chronic total occlusion (TIMI 0), left main lesion, intervention-required three-vessel lesions, and bypass lesion. 3. Severe calcification and Target lesion in a severe angulation (\> 45 degrees). 4. Patient has serious heart failure symptoms (NYHA level III or IV), or Left ventricular ejection fraction (LVEF) \<40%. 5. Patient with renal dysfunction, as Cr\>176.82umol/L or Cr \>2.0 mg/dl. 6. 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. 7. Patients with allergies to heparin and contrast media. 8. Target lesion demonstrating severe dissection prior to planned deployment of the trial device. 9. Visible thrombus at the target lesion. 10. Patients received heart transplantation. 11. Participation in another clinical trial (12 months after index procedure). 12. Those who participated in another clinical trials, but did not reach the primary endpoint.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Device Procedural Success(Lesions Level) | immediate post-intervention(approximately 1.4 hour) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedural Success (Patient Level) | During the hospital stay, up to 1 week | 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 |
| Number of Participants Who Experienced Target Lesion Failure (TLF) | During the hospital stay, up to 1 week | A composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (CI-TLR) |
| Number of Participants Who Experienced Patient-oriented Composite Endpoint (POCE) | During the hospital stay, up to 1 week | A composite of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization |
| Number of Participants With Any Adverse Events (AE) | During the hospital stay, up to 1 week | 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. |
| Number of Device Defects | During the hospital stay, up to 1 week | Report any device defect during hospitalization |
| Number of Participants With Serious Adverse Events (SAE) | During the hospital stay, up to 1 week | Report any SAE 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORjianping li, M.D/Ph.D
Peking University First Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.44 years STANDARD_DEVIATION 8.27 |
| Number of target lesions 1 Lesion | 65 Participants |
| Number of target lesions 2 Leisons | 3 Participants |
| Race/Ethnicity, Customized China | 134 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 68 |
| other Total, other adverse events | 21 / 66 | 18 / 68 |
| serious Total, serious adverse events | 1 / 66 | 1 / 68 |
Outcome results
None listed