Clinical Trials Logo
  1. Home
  2. Coronary Stenosis
  3. NCT05509296

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

Coronary Stenosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05509296
Study type Interventional
Source Sino Medical Sciences Technology Inc.
Contact
Status Completed
Phase N/A
Start date September 20, 2022
Completion date November 23, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT03427996 - Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice
Terminated NCT03175523 - HOW To Optimally Implant BioResorbable Scaffold - Intravascular Imaging Versus Quantitative Coronary Angiography Guidance N/A
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Completed NCT01184183 - Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy
Completed NCT00697372 - SEA-SIDE: Sirolimus Versus Everolimus-eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-branch Stenosis Phase 4
Recruiting NCT03054324 - Validation of a Predictive Model of Coronary Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis
Enrolling by invitation NCT06194526 - Whole Blood Transcriptomic Signal According to Coronary Atherosclerotic Plaque Burden Assessed by CT Angiography
Not yet recruiting NCT06039748 - Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study
Not yet recruiting NCT05753085 - Multimodality Optical and Ultrasound Intravascular Imaging for Stent Optimization and Atheroma Assessment N/A
Not yet recruiting NCT05471687 - Evaluation of the Functional Impact of Coronary Stenoses in Diabetics by Spectral CT N/A
Not yet recruiting NCT04569669 - The Sensitivity and Specificity of CardioSimFFRct Analysis Software on Coronary Artery Stenosis N/A
Active, not recruiting NCT02508714 - Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents N/A
Completed NCT03301246 - Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease N/A
Completed NCT03606330 - Systemic, Pancoronary and Local Coronary Vulnerability
Completed NCT02870140 - Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent N/A
Not yet recruiting NCT06071702 - IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System N/A
Completed NCT02275143 - Computed Tomography (CT) Coronary Angiogram Evaluation in Cancer Patients Having CT Thorax, Abdomen and Pelvis N/A
Active, not recruiting NCT01794065 - The Promus Element Rewards Study N/A
Completed NCT02120859 - Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty Phase 4