Back to resultsComparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy (Kissing-DCB)
Primary Purpose
Coronary Artery Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
paclitaxel DCB
DES
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- At least 18 years old;
- Evidence of myocardial ischemia and indications of PCI, stable or unstable angina pectoris, or old myocardial infarction;
- Primary and bifurcated coronary artery lesions (Medina classification 1,1,1 or 1,0,1 or 0,1,1);
- Visual angiography of the main branch reference vessel diameter ≥2.5mm, and ≤4.0mm;Branch reference vessel diameter ≥2.0mm;
- Diameter stenosis of main and branch lesions ≥ 70%, and diameter stenosis of branch lesions ≥ 50%;
- Visual examination of residual stenosis of main branch lesions after pre-dilation ≤ 30% without vascular dissection or dissection with NHLBI classification A, B, C type.
- If 2 bifurcation lesions meet the inclusion requirements, only 1 lesion can be included in the study, and the other lesion can be treated or not treated as a non-target lesion.
Exclusion Criteria:
- Main branch or branching target lesions require treatment with more than one device (DES or DCB);
- There is more than 1 non-target lesion requiring intervention on the target blood vessel;
- The distance between non-target lesion and target lesion is less than 10 mm;
- Main and branch lesions > 26 mm or branch lesions length BBB> mm;
- Left main lesion and its bifurcation lesion;
- Intra-stent restenosis or severe calcification;
- ST-segment elevation or non-ST-segment elevation myocardial infarction 7 days before surgery;
- Severe heart failure (NYHA-IV or left ventricular ejection fraction <35%);
- Cardiogenic shock;
- known to have renal failure (EGFR <30ml/min/1.73m2);
- Pregnant or lactating women, or women of reproductive age who had family planning or were unable to take adequate contraceptive measures during the study period;
- Any known allergic reactions or contraindications to the drug and coating or scaffold metal required for DCB in the study;
- Other DES or DCB treatment contraindications;
- Failing to sign an informed consent or having an expected life of less than 12 months;
- Other researchers consider it inappropriate to participate in this study.
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DCB strategy
DES strategy
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants with Target lesion failure (TLF)
Target lesion failure, defined as cardiac death, clinically driven target vessel myocardial infarction and target lesion revascularization.
Number of Participants with net adverse clinical cardiovascular events (NACCE)
Net adverse clinical cardiovascular events, defined as cardiac death, clinically driven target vessel myocardial infarction, target lesion revascularization and major bleeding (BARC type 2, 3, 5 bleeding)
Secondary Outcome Measures
Technical success rate
According to CAG, the residual stenosis of the main branch is less than 30% and the residual stenosis of the side branch is less than 50%. The blood flow is of TIMI III as well
Number of Participants with Target lesion failure (TLF)
Target lesion failure, defined as cardiac death, clinically driven target vessel myocardial infarction and target lesion revascularization
Number of Participants with Target lesion revascularization (TLR)
Target lesion revascularization, defined as clinically indicated percutaneous or surgical revascularization of the index lesion during follow-up, like using stent, balloon, coronary atherectomy, or CABG
Number of Participants with Target vessel revascularization (TVR)
Target vessel revascularization, defined as clinically indicated percutaneous or surgical revascularization of the target vessel during follow-up, like using stent, balloon, coronary atherectomy, or CABG
Clinical procedure time
The used time in the clinical procedure
DAPT using time
The using time of DAPT
Number of Participants with Bleeding events（BARC2, 3, and 5）
Definite, probable, or possible thrombus in the device defined by ARC: Acute thrombus, subacute thrombus, late thrombus, and very late thrombus
Number of Participants with ARC defines stent thrombosis
The identification and possibility of stent thrombosis were included in the time ranges of acute, subacute, late, and late
Full Information
NCT ID
NCT04842838
First Posted
April 2, 2021
Last Updated
April 9, 2021
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04842838
Brief Title
Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy
Acronym
Kissing-DCB
Official Title
Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy in the Treatment of True Bifurcation Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 30, 2021 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The trial aims to evaluate the long-term clinical outcome of the DCB-only technique is non-inferior to the provisional T stenting with DES in the patients who have 'true' bifurcation lesions.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DCB strategy
Arm Type
Experimental
Arm Title
DES strategy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
paclitaxel DCB
Intervention Description
Drug-coated balloon is a new kind of coronary interventional device. The balloon coated with anti-cell proliferation drugs (paclitaxel, etc.) is sent to the stenosis site. The balloon is closely adhered to the vascular wall during the expansion, and the drug is rapidly and evenly coated on the disaffected vessels.In recent years, DCB has gradually become an alternative for the treatment of in-stent restenosis (ISR), small vessel disease (SVD) and bifurcation disease.
Intervention Type
Device
Intervention Name(s)
DES
Intervention Description
Provisional T technique is the preferred method for the treatment of bifurcation lesions with the existing stent.According to the 2018 European Guidelines on revascularization and the consensus group of the European Bifurcation Club (EBC), Provisional T technique is still the first choice for the treatment of Bifurcation, despite the problems related to side branches.
Primary Outcome Measure Information:
Title
Number of Participants with Target lesion failure (TLF)
Description
Target lesion failure, defined as cardiac death, clinically driven target vessel myocardial infarction and target lesion revascularization.
Time Frame
12 months
Title
Number of Participants with net adverse clinical cardiovascular events (NACCE)
Description
Net adverse clinical cardiovascular events, defined as cardiac death, clinically driven target vessel myocardial infarction, target lesion revascularization and major bleeding (BARC type 2, 3, 5 bleeding)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Technical success rate
Description
According to CAG, the residual stenosis of the main branch is less than 30% and the residual stenosis of the side branch is less than 50%. The blood flow is of TIMI III as well
Time Frame
1-2 days
Title
Number of Participants with Target lesion failure (TLF)
Description
Target lesion failure, defined as cardiac death, clinically driven target vessel myocardial infarction and target lesion revascularization
Time Frame
1/6/24/36 month
Title
Number of Participants with Target lesion revascularization (TLR)
Description
Target lesion revascularization, defined as clinically indicated percutaneous or surgical revascularization of the index lesion during follow-up, like using stent, balloon, coronary atherectomy, or CABG
Time Frame
1/6/12/24/36 month
Title
Number of Participants with Target vessel revascularization (TVR)
Description
Target vessel revascularization, defined as clinically indicated percutaneous or surgical revascularization of the target vessel during follow-up, like using stent, balloon, coronary atherectomy, or CABG
Time Frame
1/6/12/24/36 month
Title
Clinical procedure time
Description
The used time in the clinical procedure
Time Frame
during the procedure
Title
DAPT using time
Description
The using time of DAPT
Time Frame
1/6/12/24/36 month
Title
Number of Participants with Bleeding events（BARC2, 3, and 5）
Description
Definite, probable, or possible thrombus in the device defined by ARC: Acute thrombus, subacute thrombus, late thrombus, and very late thrombus
Time Frame
1/6/12/24/36 month
Title
Number of Participants with ARC defines stent thrombosis
Description
The identification and possibility of stent thrombosis were included in the time ranges of acute, subacute, late, and late
Time Frame
1/6/12/24/36 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years old;
Evidence of myocardial ischemia and indications of PCI, stable or unstable angina pectoris, or old myocardial infarction;
Primary and bifurcated coronary artery lesions (Medina classification 1,1,1 or 1,0,1 or 0,1,1);
Visual angiography of the main branch reference vessel diameter ≥2.5mm, and ≤4.0mm;Branch reference vessel diameter ≥2.0mm;
Diameter stenosis of main and branch lesions ≥ 70%, and diameter stenosis of branch lesions ≥ 50%;
Visual examination of residual stenosis of main branch lesions after pre-dilation ≤ 30% without vascular dissection or dissection with NHLBI classification A, B, C type.
If 2 bifurcation lesions meet the inclusion requirements, only 1 lesion can be included in the study, and the other lesion can be treated or not treated as a non-target lesion.
Exclusion Criteria:
Main branch or branching target lesions require treatment with more than one device (DES or DCB);
There is more than 1 non-target lesion requiring intervention on the target blood vessel;
The distance between non-target lesion and target lesion is less than 10 mm;
Main and branch lesions > 26 mm or branch lesions length BBB> mm;
Left main lesion and its bifurcation lesion;
Intra-stent restenosis or severe calcification;
ST-segment elevation or non-ST-segment elevation myocardial infarction 7 days before surgery;
Severe heart failure (NYHA-IV or left ventricular ejection fraction <35%);
Cardiogenic shock;
known to have renal failure (EGFR <30ml/min/1.73m2);
Pregnant or lactating women, or women of reproductive age who had family planning or were unable to take adequate contraceptive measures during the study period;
Any known allergic reactions or contraindications to the drug and coating or scaffold metal required for DCB in the study;
Other DES or DCB treatment contraindications;
Failing to sign an informed consent or having an expected life of less than 12 months;
Other researchers consider it inappropriate to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yida Tang, Prof
Phone
13901010211
Email
tang_yida@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yupeng Wang, Prof
Email
wangyp007@163.com
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yida Tang, Prof
Email
tang_yida@163.com
First Name & Middle Initial & Last Name & Degree
Yupeng Wang, Prof
Email
wangyp007@163.com
12. IPD Sharing Statement
Learn more about this trial
Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy
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