Back to resultsSafety and Efficacy of Spinous Balloon Dilatation Catheter in CAD Treatment
Primary Purpose
Coronary Artery Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
spinous balloon dilatation catheter (Plastic-Blade)
spinous balloon dilatation catheter(lacrosse NSE)
Sponsored by
About this trial
This is an interventional other trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- 1. 18-75 years
- 2.Stable or unstable angina, or previous myocardial infarction, or Asymptomatic ischemia judged by clinician ,Target vascular diameter: 2.00-4.00mm ,Coronary artery stenosis stenosis ≥ 70% by visual inspection, or ≥ 50% with evidence of ischemia, TIMI blood flow≥ 1,the operator judge that the patient needs spinous balloon to treat.
- 3. Paticipant can understand the study ,voluntarily participate in and sign the informed consent form,and accept scheduled follow-up.
Exclusion Criteria:
Patient related:
- 1.Pregnant and breast-feeding women or intention to be pregnant.
- 2.Subjects with MI within one week, or more than one week after the onset of MI,but TNI or TNT have not returned to normal.
- 3.The spinous balloon failed to pass through the stenosis after small balloon dilation , and the lesion need to be rotary grinded.
- 4. Non-target vessel did not be dealed with successful before dealing with target vessel, or non-target vascular lesion number is more than three.
- 5.Serious heart failure（NYHA IV）
- 6.Severe renal failure（Cr>443uMol/L) or patients undergoing hemodialysis.
- 7.Patient with heart transplant.
- 8.Patient with CABG.
- 9.Patients with hemodynamic instability or shock symptoms.
- 10.Life expectancy less than one year.
- 11.Expected to undergo surgery within one month.
- 12.Patients with bleeding tendency, history of active gastrointestinal ulcer, contraindications of antiplatelet or anticoagulant treatment, cannot receive anticoagulant treatment, and patients have hemorrhagic stroke within six months.
- 13.Allergy to heparin and contrast agent.
- 14.The illness of the patient make the treatment and evaluation difficult.
- 15.Those who have participated in other drug or medical device trials have not reached main research endpoint.
- 16.Clinicians estimated that the risk of intervention is very high or the patient should be excluded for other reasons.
- 17.Poor of compliance
Lesion related:
- 18.Lesions of LAD or with a distance of ≤ 2mm beyond LAD.
- 19.Angiogram showed thrombus.
- 20.CTO,and TIMI blood flow=0,
- 21.Coronary artery spasm
- 22.Lesions of LAD without bypass surgery or collateral circulation protection.
- 23.The doctor considered the patient unfit for the trial.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
spinous balloon dilatation catheter(Plastic-Blade)
spinous balloon dilatation catheter(lacrosse NSE)
Arm Description
Patients with CAD will be treated with spinous balloon dilatation catheter(Plastic-Blade).
Patients with CAD will be treated with spinous balloon dilatation catheter(lacrosse NSE)
Outcomes
Primary Outcome Measures
Immediate lumen acquisition
The difference of the minimum diameter of the target lesion before and after balloon dilatation in the test or control group measured by QCA.
Secondary Outcome Measures
Rate of device success
Proportion of patients who meet the success criteria. Success criteria be defined as the residual stenosis of the target lesion is less than 50% after balloon dilatation and the balloon delivery system is successfully withdrawn
Rate of clinical success
Based on device success, no patient occurred composite endpoint (PoCE) during hospitalization
Incidence of related complications
Including acute occlusion, vasospasm, vascular rupture, branch or collateral occlusion, subacute stent thrombosis, intimal tear, dissection, etc.
% change of clinically meaningful laboratory tests
Record the change of clinically meaningful laboratory tests
Number of adverse events
Adverse events occurred during balloon dilatation, after balloon dilatation to 30 ± 7 days after discharge
Number of device related composite endpoint
Including TLF, Cardiac Death, TV-MI and ID-TLR
Number of patient oriented composite endpoint
Including all cause death, MI, TLR, TVR, Revascularization of any coronary arteries and thrombus at the lesion.
Total time of device operation performance
Push capacity, passing capacity and withdrawal capacity
Full Information
NCT ID
NCT05342961
First Posted
March 15, 2022
Last Updated
April 21, 2022
Sponsor
CCRF Inc., Beijing, China
Collaborators
Shanghai 10th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05342961
Brief Title
Safety and Efficacy of Spinous Balloon Dilatation Catheter in CAD Treatment
Official Title
A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Spinous Balloon Dilatation Catheter (Plastic-BladeTM) in the Treatment of Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 16, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CCRF Inc., Beijing, China
Collaborators
Shanghai 10th People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of spinous process balloon dilation catheter (Plastic-Blade) in coronary vascular diseases, which is not inferior to the similar product on the market - coronary spinous process balloon dilation catheter (lacrosse NSE) produced by Goodman Co., Ltd..
Detailed Description
This study is a prospective, multicenter, randomized, controlled and non inferiority designed clinical trial. A total of 160 subjects with CAD from 8 centers will be randomized 1:1 to each group. All subjects evaluated the immediate lumen acquisition immediately after operation and the MACE of 30 ± 7 days after operation. The primary endpoint is the acquisition of lumen immediately after operation. The effectiveness of balloon was evaluated. The safety of balloon was evaluated by adverse events during operation.Clinical follow-up will be conducted at operation, discharge and 30 ± 7 days after operation. The target lesions included the following : opening lesions, bifurcation lesions, calcification lesions and fibrosis lesions; Diameter stenosis ≥ 70% (visual) with evidence of ischemia; Localized lesions with TIMI ≥ 1; RVD=2.00 and 4.00mm , and the vascular segment is suitable for balloon dilatation in anatomical structure。
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
During the study, it is difficult for researchers, operators and patients to blind the method due to objective reasons.
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
spinous balloon dilatation catheter(Plastic-Blade)
Arm Type
Experimental
Arm Description
Patients with CAD will be treated with spinous balloon dilatation catheter(Plastic-Blade).
Arm Title
spinous balloon dilatation catheter(lacrosse NSE)
Arm Type
Experimental
Arm Description
Patients with CAD will be treated with spinous balloon dilatation catheter(lacrosse NSE)
Intervention Type
Procedure
Intervention Name(s)
spinous balloon dilatation catheter (Plastic-Blade)
Intervention Description
To treat Coronary artery disease
Intervention Type
Procedure
Intervention Name(s)
spinous balloon dilatation catheter(lacrosse NSE)
Intervention Description
To treat Coronary artery disease
Primary Outcome Measure Information:
Title
Immediate lumen acquisition
Description
The difference of the minimum diameter of the target lesion before and after balloon dilatation in the test or control group measured by QCA.
Time Frame
during the procedure
Secondary Outcome Measure Information:
Title
Rate of device success
Description
Proportion of patients who meet the success criteria. Success criteria be defined as the residual stenosis of the target lesion is less than 50% after balloon dilatation and the balloon delivery system is successfully withdrawn
Time Frame
during the procedure
Title
Rate of clinical success
Description
Based on device success, no patient occurred composite endpoint (PoCE) during hospitalization
Time Frame
from procedure to discharge ( to the 7th day after procedure)
Title
Incidence of related complications
Description
Including acute occlusion, vasospasm, vascular rupture, branch or collateral occlusion, subacute stent thrombosis, intimal tear, dissection, etc.
Time Frame
30 days after balloon dilatation
Title
% change of clinically meaningful laboratory tests
Description
Record the change of clinically meaningful laboratory tests
Time Frame
30 days after procedure
Title
Number of adverse events
Description
Adverse events occurred during balloon dilatation, after balloon dilatation to 30 ± 7 days after discharge
Time Frame
30 days
Title
Number of device related composite endpoint
Description
Including TLF, Cardiac Death, TV-MI and ID-TLR
Time Frame
30 days
Title
Number of patient oriented composite endpoint
Description
Including all cause death, MI, TLR, TVR, Revascularization of any coronary arteries and thrombus at the lesion.
Time Frame
30 days
Title
Total time of device operation performance
Description
Push capacity, passing capacity and withdrawal capacity
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. 18-75 years
2.Stable or unstable angina, or previous myocardial infarction, or Asymptomatic ischemia judged by clinician ,Target vascular diameter: 2.00-4.00mm ,Coronary artery stenosis stenosis ≥ 70% by visual inspection, or ≥ 50% with evidence of ischemia, TIMI blood flow≥ 1,the operator judge that the patient needs spinous balloon to treat.
3. Paticipant can understand the study ,voluntarily participate in and sign the informed consent form,and accept scheduled follow-up.
Exclusion Criteria:
Patient related:
1.Pregnant and breast-feeding women or intention to be pregnant.
2.Subjects with MI within one week, or more than one week after the onset of MI,but TNI or TNT have not returned to normal.
3.The spinous balloon failed to pass through the stenosis after small balloon dilation , and the lesion need to be rotary grinded.
4. Non-target vessel did not be dealed with successful before dealing with target vessel, or non-target vascular lesion number is more than three.
5.Serious heart failure（NYHA IV）
6.Severe renal failure（Cr>443uMol/L) or patients undergoing hemodialysis.
7.Patient with heart transplant.
8.Patient with CABG.
9.Patients with hemodynamic instability or shock symptoms.
10.Life expectancy less than one year.
11.Expected to undergo surgery within one month.
12.Patients with bleeding tendency, history of active gastrointestinal ulcer, contraindications of antiplatelet or anticoagulant treatment, cannot receive anticoagulant treatment, and patients have hemorrhagic stroke within six months.
13.Allergy to heparin and contrast agent.
14.The illness of the patient make the treatment and evaluation difficult.
15.Those who have participated in other drug or medical device trials have not reached main research endpoint.
16.Clinicians estimated that the risk of intervention is very high or the patient should be excluded for other reasons.
17.Poor of compliance
Lesion related:
18.Lesions of LAD or with a distance of ≤ 2mm beyond LAD.
19.Angiogram showed thrombus.
20.CTO,and TIMI blood flow=0,
21.Coronary artery spasm
22.Lesions of LAD without bypass surgery or collateral circulation protection.
23.The doctor considered the patient unfit for the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Zhang, M.D.
Phone
86-21-66300588
Email
yizshcn@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yawei Xu, MD.,Ph D.
Organizational Affiliation
Department of Cardiology, Shanghai Tenth People's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Efficacy of Spinous Balloon Dilatation Catheter in CAD Treatment
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