Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease

A Prospective, Multicenter, Randomized Control, Non-inferiority to Investigate the Effectiveness and Safety of SINOMED CBC for Endovascular Treatment of Stenotic Coronary Artery Disease

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.

Study Overview

• Status: Completed
• Conditions: Coronary Stenosis; Coronary Artery Stenosis; In-stent Restenosis
• Intervention / Treatment: Device: SINOMED CBC; Device: NSE Coronary Dilatation Catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
  • Beijing, China
    • Peking University Third Hospital
  • Kaifeng, China
    • Kaifeng Central Hospital
  • Lianyungang, China
    • The First People's Hospital of Lianyungang
  • Tianjin, China
    • Tianjin Chest Hospital
  • Tianjin, China
    • Tianjin Forth Central Hospital
  • Wuxi, China
    • Wuxi People's Hospital
  • Xuzhou, China
    • Xuzhou cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SINOMED CBC; Cutting balloon catheter (Sino Medical Sciences Technology Inc.)	Device: 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.; Other Names: cutting balloon catheter; scoring balloon catheter
Active Comparator: NSE Coronary Dilatation Catheter; NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)	Device: 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.; Other Names: Lacrosse NSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Device Procedural Success(Lesions 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%)	immediate post-intervention(approximately 1.4 hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 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	During the hospital stay, up to 1 week
Number of Participants Who Experienced Target Lesion Failure (TLF)	A composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (CI-TLR)	During the hospital stay, up to 1 week
Number of Participants Who Experienced Patient-oriented Composite Endpoint (POCE)	A composite of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization	During the hospital stay, up to 1 week
Number of Participants With Any Adverse Events (AE)	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.	During the hospital stay, up to 1 week
Number of Device Defects	Report any device defect during hospitalization	During the hospital stay, up to 1 week
Number of Participants With Serious Adverse Events (SAE)	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.	During the hospital stay, up to 1 week

Collaborators and Investigators

• Sponsor: Sino Medical Sciences Technology Inc.
• Collaborators: Peking University First Hospital
• Investigators: Principal Investigator: jianping li, M.D/Ph.D, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Actual): November 23, 2022
• Study Completion (Actual): November 23, 2022

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Restenosis; Coronary dilation catheter; Percutaneous coronary artery dilatation; Cutting balloon catheter; scoring balloon catheter
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Coronary Stenosis
• Other Study ID Numbers: SN-CBC-202201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No