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

February 29, 2024 updated by: Sino Medical Sciences Technology Inc.

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Rate of Device procedural success (lesion level)
Time Frame: 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%)
immediate post-intervention(approximately 1.4 hour)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Procedural success (patient level)
Time Frame: 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
during the hospital stay, an average of 7 days post-procedure
Rate of Target lesion failure (TLF)
Time Frame: 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)
during the hospital stay, an average of 7 days post-procedure
Rate of Patient-oriented composite endpoint (POCE)
Time Frame: 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
during the hospital stay, an average of 7 days post-procedure
Incidence of any AE and SAE incidence
Time Frame: 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.
during the hospital stay, an average of 7 days post-procedure
Rate of device defect
Time Frame: during the hospital stay, an average of 7 days post-procedure
report any device defect during hospitalization
during the hospital stay, an average of 7 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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