Clinical trial NCT05509296: Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease
Official title: A Prospective, Multicenter, Randomized Control, Non-inferiority to Investigate the Effectiveness and Safety of SINOMED CBC for Endovascular Treatment of Stenotic Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Stenosis
Coronary Artery Stenosis
In-stent Restenosis
Keywords: Coronary dilation catheter
Percutaneous coronary artery dilatation
Restenosis
Cutting balloon catheter
scoring balloon catheter
Lead sponsor: Sino Medical Sciences Technology Inc.
Sponsor class: INDUSTRY
Collaborators: name: Peking University First Hospital
First posted: 2022-08-22
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, multicenter, randomized control,non-inferiority clinical study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Device procedural success (lesion level)
timeFrame: immediate post-intervention(approximately 1.4 hour)
Secondary outcomes:
measure: Rate of Procedural success (patient level)
timeFrame: during the hospital stay, an average of 7 days post-procedure
measure: Rate of Target lesion failure (TLF)
timeFrame: during the hospital stay, an average of 7 days post-procedure
measure: Rate of Patient-oriented composite endpoint (POCE)
timeFrame: during the hospital stay, an average of 7 days post-procedure
measure: Incidence of any AE and SAE incidence
timeFrame: during the hospital stay, an average of 7 days post-procedure
measure: Rate of device defect
timeFrame: during the hospital stay, an average of 7 days post-procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
city: Lianyungang
country: China
facility: The First People's Hospital of Lianyungang
city: Tianjin
country: China
facility: Tianjin Chest Hospital
city: Tianjin
country: China
facility: Tianjin Forth Central Hospital
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Xuzhou
country: China
facility: Xuzhou cancer hospital
Study officials:
affiliation: Peking University First Hospital
name: jianping li, M.D/Ph.D
role: PRINCIPAL_INVESTIGATOR
References: