NCT05509296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2022

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

August 16, 2022

Results QC Date

January 27, 2026

Last Update Submit

March 25, 2026

Conditions

Coronary StenosisCoronary Artery StenosisIn-stent Restenosis

Keywords

Coronary dilation catheterPercutaneous coronary artery dilatationRestenosisCutting balloon catheterscoring balloon catheter

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Number of Participants With Procedural Success (Patient Level)

    During the hospital stay, up to 1 week

  • Number of Participants Who Experienced Target Lesion Failure (TLF)

    During the hospital stay, up to 1 week

  • Number of Participants Who Experienced Patient-oriented Composite Endpoint (POCE)

    During the hospital stay, up to 1 week

  • Number of Participants With Any Adverse Events (AE)

    During the hospital stay, up to 1 week

  • Number of Device Defects

    During the hospital stay, up to 1 week

  • +1 more secondary outcomes

Study Arms (2)

SINOMED CBC

EXPERIMENTAL

Cutting balloon catheter (Sino Medical Sciences Technology Inc.)

Device: SINOMED CBC

NSE Coronary Dilatation Catheter

ACTIVE COMPARATOR

NSE Coronary Dilatation Catheter (Goodman Co.,Ltd)

Device: NSE Coronary Dilatation Catheter

Interventions

SINOMED CBCDEVICE

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.

Also known as: cutting balloon catheter, scoring balloon catheter
SINOMED CBC
NSE Coronary Dilatation CatheterDEVICE

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.

Also known as: Lacrosse NSE
NSE Coronary Dilatation Catheter

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient is at least 18 to 75 years of age, male or not pregnant female.
  • Evidence of myocardial ischemia without symptoms, stable or unstable angina, silent ischemia demonstrated by positive territorial functional study, or old myocardial infarction.
  • De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis.
  • Reference vessel diameter (RVD) must be visually estimated ≥ 2.5 and ≤ 5.0mm, and the vessel length must be no more than 30mm.
  • Target lesion(s) must have a diameter stenosis of (a) ≥70% by visual estimation or (b) \>50% with evidence of ischemia.
  • The patient has a planned intervention at no more than two de novo lesions, in different epicardial vessels.
  • Investigators believe that target lesion atherosclerotic plaques require spinous balloon treatment and balloon can be passed through by pre-dilation.
  • Able to understand the purpose of the trial, voluntarily participate and sign the informed consent.

You may not qualify if:

  • Evidence of ongoing acute myocardial infarction within a week.
  • Chronic total occlusion (TIMI 0), left main lesion, intervention-required three-vessel lesions, and bypass lesion.
  • Severe calcification and Target lesion in a severe angulation (\> 45 degrees).
  • Patient has serious heart failure symptoms (NYHA level III or IV), or Left ventricular ejection fraction (LVEF) \<40%.
  • Patient with renal dysfunction, as Cr\>176.82umol/L or Cr \>2.0 mg/dl.
  • 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.
  • Patients with allergies to heparin and contrast media.
  • Target lesion demonstrating severe dissection prior to planned deployment of the trial device.
  • Visible thrombus at the target lesion.
  • Patients received heart transplantation.
  • Participation in another clinical trial (12 months after index procedure).
  • Those who participated in another clinical trials, but did not reach the primary endpoint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Peking University First Hospital

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

Kaifeng Central Hospital

Kaifeng, China

Location

The First People's Hospital of Lianyungang

Lianyungang, China

Location

Tianjin Chest Hospital

Tianjin, China

Location

Tianjin Forth Central Hospital

Tianjin, China

Location

Wuxi People's Hospital

Wuxi, China

Location

Xuzhou cancer hospital

Xuzhou, China

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Results Point of Contact

Title
Piper
Organization
Sino Medical Sciences Technology Inc.
pichaoqiong@sinomed.com
010 8048 2242

Study Officials

  • jianping li, M.D/Ph.D

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, multicenter, randomized control,non-inferiority clinical study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 22, 2022

Study Start

September 20, 2022

Primary Completion

November 23, 2022

Study Completion

November 23, 2022

Last Updated

March 27, 2026

Results First Posted

March 27, 2026

Record last verified: 2026-03

Locations

CN(8)