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

Sino Medical Sciences Technology

Status: Completed

Conditions: Coronary Artery Stenosis; In-stent Restenosis; Coronary Stenosis

Treatments: Device: NSE Coronary Dilatation Catheter; Device: SINOMED CBC

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05509296

SN-CBC-202201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

SINOMED CBC

Experimental group

Description:

Cutting balloon catheter (Sino Medical Sciences Technology Inc.)

Treatment:

Device: SINOMED CBC

NSE Coronary Dilatation Catheter

Active Comparator group

Description:

NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)

Treatment:

Device: NSE Coronary Dilatation Catheter