Trial Outcomes & Findings for Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease (NCT NCT05509296)
NCT ID: NCT05509296
Last Updated: 2026-03-27
Results Overview
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%)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
136 participants
Primary outcome timeframe
immediate post-intervention(approximately 1.4 hour)
Results posted on
2026-03-27
Participant Flow
Participant milestones
| Measure |
SINOMED CBC
Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
SINOMED 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.
|
NSE Coronary Dilatation Catheter
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)
NSE Coronary Dilatation Catheter: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
69
|
|
Overall Study
COMPLETED
|
66
|
68
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease
Baseline characteristics by cohort
| Measure |
SINOMED CBC
n=66 Participants
Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
SINOMED 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.
|
NSE Coronary Dilatation Catheter
n=68 Participants
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)
NSE Coronary Dilatation Catheter: 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.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.44 years
STANDARD_DEVIATION 8.27 • n=56 Participants
|
63.72 years
STANDARD_DEVIATION 8.16 • n=62 Participants
|
63.09 years
STANDARD_DEVIATION 8.21 • n=123 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=56 Participants
|
22 Participants
n=62 Participants
|
41 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=56 Participants
|
46 Participants
n=62 Participants
|
93 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
China
|
66 Participants
n=56 Participants
|
68 Participants
n=62 Participants
|
134 Participants
n=123 Participants
|
|
Number of target lesions
1 Lesion
|
63 Participants
n=56 Participants
|
65 Participants
n=62 Participants
|
128 Participants
n=123 Participants
|
|
Number of target lesions
2 Leisons
|
3 Participants
n=56 Participants
|
3 Participants
n=62 Participants
|
6 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: immediate post-intervention(approximately 1.4 hour)Population: lesions
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%)
Outcome measures
| Measure |
SINOMED CBC
n=69 Lesions
Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
SINOMED 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.
|
NSE Coronary Dilatation Catheter
n=71 Lesions
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)
NSE Coronary Dilatation Catheter: 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.
|
|---|---|---|
|
Number of Device Procedural Success(Lesions Level)
|
68 lesions
|
68 lesions
|
SECONDARY outcome
Timeframe: During the hospital stay, up to 1 weekDefined 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
Outcome measures
| Measure |
SINOMED CBC
n=66 Participants
Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
SINOMED 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.
|
NSE Coronary Dilatation Catheter
n=68 Participants
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)
NSE Coronary Dilatation Catheter: 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.
|
|---|---|---|
|
Number of Participants With Procedural Success (Patient Level)
|
65 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: During the hospital stay, up to 1 weekA composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (CI-TLR)
Outcome measures
| Measure |
SINOMED CBC
n=66 Participants
Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
SINOMED 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.
|
NSE Coronary Dilatation Catheter
n=68 Participants
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)
NSE Coronary Dilatation Catheter: 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.
|
|---|---|---|
|
Number of Participants Who Experienced Target Lesion Failure (TLF)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the hospital stay, up to 1 weekA composite of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization
Outcome measures
| Measure |
SINOMED CBC
n=66 Participants
Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
SINOMED 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.
|
NSE Coronary Dilatation Catheter
n=68 Participants
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)
NSE Coronary Dilatation Catheter: 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.
|
|---|---|---|
|
Number of Participants Who Experienced Patient-oriented Composite Endpoint (POCE)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the hospital stay, up to 1 weekReport 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.
Outcome measures
| Measure |
SINOMED CBC
n=66 Participants
Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
SINOMED 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.
|
NSE Coronary Dilatation Catheter
n=68 Participants
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)
NSE Coronary Dilatation Catheter: 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.
|
|---|---|---|
|
Number of Participants With Any Adverse Events (AE)
|
21 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: During the hospital stay, up to 1 weekReport any device defect during hospitalization
Outcome measures
| Measure |
SINOMED CBC
n=66 Participants
Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
SINOMED 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.
|
NSE Coronary Dilatation Catheter
n=68 Participants
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)
NSE Coronary Dilatation Catheter: 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.
|
|---|---|---|
|
Number of Device Defects
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the hospital stay, up to 1 weekReport 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.
Outcome measures
| Measure |
SINOMED CBC
n=66 Participants
Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
SINOMED 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.
|
NSE Coronary Dilatation Catheter
n=68 Participants
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)
NSE Coronary Dilatation Catheter: 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.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAE)
|
1 Participants
|
1 Participants
|
Adverse Events
SINOMED CBC
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
NSE Coronary Dilatation Catheter
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SINOMED CBC
n=66 participants at risk
Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
SINOMED 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.
|
NSE Coronary Dilatation Catheter
n=68 participants at risk
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)
NSE Coronary Dilatation Catheter: 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.
|
|---|---|---|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/66 • During the hospital, up to 1 week
|
1.5%
1/68 • During the hospital, up to 1 week
|
|
Vascular disorders
Mesenteric arteriosclerosis
|
1.5%
1/66 • During the hospital, up to 1 week
|
0.00%
0/68 • During the hospital, up to 1 week
|
Other adverse events
| Measure |
SINOMED CBC
n=66 participants at risk
Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
SINOMED 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.
|
NSE Coronary Dilatation Catheter
n=68 participants at risk
NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)
NSE Coronary Dilatation Catheter: 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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/66 • During the hospital, up to 1 week
|
1.5%
1/68 • During the hospital, up to 1 week
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/66 • During the hospital, up to 1 week
|
0.00%
0/68 • During the hospital, up to 1 week
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
1.5%
1/66 • During the hospital, up to 1 week
|
0.00%
0/68 • During the hospital, up to 1 week
|
|
Immune system disorders
Hypersensitivity
|
1.5%
1/66 • During the hospital, up to 1 week
|
0.00%
0/68 • During the hospital, up to 1 week
|
|
Injury, poisoning and procedural complications
Peripheral edema
|
1.5%
1/66 • During the hospital, up to 1 week
|
0.00%
0/68 • During the hospital, up to 1 week
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/66 • During the hospital, up to 1 week
|
1.5%
1/68 • During the hospital, up to 1 week
|
|
Eye disorders
Visual field loss
|
0.00%
0/66 • During the hospital, up to 1 week
|
1.5%
1/68 • During the hospital, up to 1 week
|
|
Gastrointestinal disorders
Gingival hemorrhage
|
0.00%
0/66 • During the hospital, up to 1 week
|
2.9%
2/68 • During the hospital, up to 1 week
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/66 • During the hospital, up to 1 week
|
0.00%
0/68 • During the hospital, up to 1 week
|
|
Psychiatric disorders
Insomnia
|
3.0%
2/66 • During the hospital, up to 1 week
|
0.00%
0/68 • During the hospital, up to 1 week
|
|
Psychiatric disorders
Anxiety
|
1.5%
1/66 • During the hospital, up to 1 week
|
0.00%
0/68 • During the hospital, up to 1 week
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
2/66 • During the hospital, up to 1 week
|
0.00%
0/68 • During the hospital, up to 1 week
|
|
Nervous system disorders
Headache
|
0.00%
0/66 • During the hospital, up to 1 week
|
1.5%
1/68 • During the hospital, up to 1 week
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
1/66 • During the hospital, up to 1 week
|
1.5%
1/68 • During the hospital, up to 1 week
|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
2/66 • During the hospital, up to 1 week
|
0.00%
0/68 • During the hospital, up to 1 week
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.5%
3/66 • During the hospital, up to 1 week
|
2.9%
2/68 • During the hospital, up to 1 week
|
|
Metabolism and nutrition disorders
Hyperlipemia
|
1.5%
1/66 • During the hospital, up to 1 week
|
1.5%
1/68 • During the hospital, up to 1 week
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.5%
1/66 • During the hospital, up to 1 week
|
1.5%
1/68 • During the hospital, up to 1 week
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.5%
1/66 • During the hospital, up to 1 week
|
0.00%
0/68 • During the hospital, up to 1 week
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/66 • During the hospital, up to 1 week
|
1.5%
1/68 • During the hospital, up to 1 week
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/66 • During the hospital, up to 1 week
|
1.5%
1/68 • During the hospital, up to 1 week
|
|
Cardiac disorders
Myocardial injury
|
9.1%
6/66 • During the hospital, up to 1 week
|
7.4%
5/68 • During the hospital, up to 1 week
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/66 • During the hospital, up to 1 week
|
0.00%
0/68 • During the hospital, up to 1 week
|
|
Cardiac disorders
Chest pain
|
0.00%
0/66 • During the hospital, up to 1 week
|
1.5%
1/68 • During the hospital, up to 1 week
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/66 • During the hospital, up to 1 week
|
2.9%
2/68 • During the hospital, up to 1 week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place