Coronary Artery DiseaseKissing-DCBNCT04842838
Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy
A study testing paclitaxel DCB and DES in people with Coronary Artery Disease, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- paclitaxel DCB and DES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Yupeng Wang, Prof contact
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality
Yida Tang, Prof, tang_yida@163.com
Yupeng Wang, Prof, wangyp007@163.com
About this study
Official title: Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy in the Treatment of True Bifurcation Coronary Artery Disease
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.
- Conditions
- Coronary Artery Disease
- Being tested
- paclitaxel DCB, DES
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel DCBDevice
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.
DESDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| DCB strategy | Experimental | Not described Receives: Device: paclitaxel DCB |
| DES strategy | Active comparator | Not described Receives: Device: DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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)
Measured: 12 months
Secondary outcomes (8)
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
Measured: 1-2 days
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
Measured: 1/6/24/36 month
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
Measured: 1/6/12/24/36 month
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
Measured: 1/6/12/24/36 month
Clinical procedure time
The used time in the clinical procedure
Measured: during the procedure
DAPT using time
The using time of DAPT
Measured: 1/6/12/24/36 month
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
Measured: 1/6/12/24/36 month
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
Measured: 1/6/12/24/36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start30 Jun 2021 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842838
- Sponsor's protocol ID
- CAW-PMS-R01-01
- Acronym
- Kissing-DCB
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy in the Treatment of True Bifurcation Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04842838
- Acronym / sponsor ID
- Kissing-DCB / CAW-PMS-R01-01
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCB strategy | Experimental | Device: paclitaxel DCB |
| DES strategy | Active comparator | Device: DES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxel DCBDrug-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. | Device | DCB strategy |
| DESProvisional 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. | Device | DES strategy |
Primary outcome
Number of Participants with Target lesion failure (TLF)
Time frame: 12 months
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)
Time frame: 12 months
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)
8 secondary outcomes
Technical success rate
Time frame: 1-2 days
Number of Participants with Target lesion failure (TLF)
Time frame: 1/6/24/36 month
Number of Participants with Target lesion revascularization (TLR)
Time frame: 1/6/12/24/36 month
Number of Participants with Target vessel revascularization (TVR)
Time frame: 1/6/12/24/36 month
Clinical procedure time
Time frame: during the procedure
DAPT using time
Time frame: 1/6/12/24/36 month
Number of Participants with Bleeding events（BARC2, 3, and 5）
Time frame: 1/6/12/24/36 month
Number of Participants with ARC defines stent thrombosis
Time frame: 1/6/12/24/36 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yupeng Wang, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paclitaxel DCB and DES in people with Coronary Artery Disease, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yida Tang, Prof (13901010211, tang_yida@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Target lesion failure (TLF) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.