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

Not Applicable

Completed

• Conditions: Coronary Stenosis; Coronary Artery Stenosis; In-stent Restenosis
• Interventions: Device: SINOMED CBC; Device: NSE Coronary Dilatation Catheter

• Registration Number: NCT05509296
• Lead Sponsor: Sino Medical Sciences Technology Inc.

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.

Study Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-22
• Study Start: 2022-09-20
• Primary Completion: 2022-11-23
• Study Completion: 2022-11-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SINOMED CBC	SINOMED CBC	Cutting balloon catheter (Sino Medical Sciences Technology Inc.)
NSE Coronary Dilatation Catheter	NSE Coronary Dilatation Catheter	NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)

Primary Outcome Measures

Name	Time	Method
Rate of Device procedural success (lesion 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 Outcome Measures

Name	Time	Method
Incidence of any AE and SAE incidence	during the hospital stay, an average of 7 days post-procedure	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 Patient-oriented composite endpoint (POCE)	during the hospital stay, an average of 7 days post-procedure	a composite of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization
Rate of Target lesion failure (TLF)	during the hospital stay, an average of 7 days post-procedure	a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (CI-TLR)
Rate of Procedural success (patient level)	during the hospital stay, an average of 7 days post-procedure	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 device defect	during the hospital stay, an average of 7 days post-procedure	report any device defect during hospitalization

Trial Locations

Locations (8)

Peking University First Hospital; 🇨🇳 Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, China

Kaifeng Central Hospital; 🇨🇳 Kaifeng, China

Tianjin Forth Central Hospital; 🇨🇳 Tianjin, China

Tianjin Chest Hospital; 🇨🇳 Tianjin, China

Wuxi People's Hospital; 🇨🇳 Wuxi, China

The First People's Hospital of Lianyungang; 🇨🇳 Lianyungang, China

Xuzhou cancer hospital; 🇨🇳 Xuzhou, China