Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy (Kissing-DCB)

• ClinicalTrials.gov Identifier: NCT04842838
• Recruitment Status: Not yet recruiting
• First Posted: April 13, 2021
• Last Update Posted: April 13, 2021
• Sponsor: Peking University Third Hospital
• Information provided by (Responsible Party): Peking University Third Hospital

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Device: paclitaxel DCB; Device: DES	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy in the Treatment of True Bifurcation Coronary Artery Disease
• Estimated Study Start Date: June 30, 2021
• Estimated Primary Completion Date: June 30, 2023
• Estimated Study Completion Date: June 30, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: DCB strategy	Device: paclitaxel DCB; 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.
Active Comparator: DES strategy	Device: DES; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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)

Secondary Outcome Measures :

1. Technical success rate [ Time Frame: 1-2 days ]
   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
2. Number of Participants with Target lesion failure (TLF) [ Time Frame: 1/6/24/36 month ]
   Target lesion failure, defined as cardiac death, clinically driven target vessel myocardial infarction and target lesion revascularization
3. Number of Participants with Target lesion revascularization (TLR) [ Time Frame: 1/6/12/24/36 month ]
   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
4. Number of Participants with Target vessel revascularization (TVR) [ Time Frame: 1/6/12/24/36 month ]
   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
5. Clinical procedure time [ Time Frame: during the procedure ]
   The used time in the clinical procedure
6. DAPT using time [ Time Frame: 1/6/12/24/36 month ]
   The using time of DAPT
7. Number of Participants with Bleeding events（BARC2, 3, and 5） [ Time Frame: 1/6/12/24/36 month ]
   Definite, probable, or possible thrombus in the device defined by ARC: Acute thrombus, subacute thrombus, late thrombus, and very late thrombus
8. Number of Participants with ARC defines stent thrombosis [ Time Frame: 1/6/12/24/36 month ]
   The identification and possibility of stent thrombosis were included in the time ranges of acute, subacute, late, and late

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. At least 18 years old;
2. Evidence of myocardial ischemia and indications of PCI, stable or unstable angina pectoris, or old myocardial infarction;
3. Primary and bifurcated coronary artery lesions (Medina classification 1,1,1 or 1,0,1 or 0,1,1);
4. Visual angiography of the main branch reference vessel diameter ≥2.5mm, and ≤4.0mm;Branch reference vessel diameter ≥2.0mm;
5. Diameter stenosis of main and branch lesions ≥ 70%, and diameter stenosis of branch lesions ≥ 50%;
6. 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.
7. 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:

1. Main branch or branching target lesions require treatment with more than one device (DES or DCB);
2. There is more than 1 non-target lesion requiring intervention on the target blood vessel;
3. The distance between non-target lesion and target lesion is less than 10 mm;
4. Main and branch lesions > 26 mm or branch lesions length BBB> mm;
5. Left main lesion and its bifurcation lesion;
6. Intra-stent restenosis or severe calcification;
7. ST-segment elevation or non-ST-segment elevation myocardial infarction 7 days before surgery;
8. Severe heart failure (NYHA-IV or left ventricular ejection fraction <35%);
9. Cardiogenic shock;
10. known to have renal failure (EGFR <30ml/min/1.73m2);
11. 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;
12. Any known allergic reactions or contraindications to the drug and coating or scaffold metal required for DCB in the study;
13. Other DES or DCB treatment contraindications;
14. Failing to sign an informed consent or having an expected life of less than 12 months;
15. Other researchers consider it inappropriate to participate in this study.

Contacts and Locations

Contacts

Contact: Yida Tang, Prof; 13901010211; tang_yida@163.com

Contact: Yupeng Wang, Prof; wangyp007@163.com

Locations

China, Beijing

Peking University Third Hospital

Beijing, Beijing, China

Contact: Yida Tang, Prof tang_yida@163.com

Contact: Yupeng Wang, Prof wangyp007@163.com

Sponsors and Collaborators

Peking University Third Hospital

More Information

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04842838
• Other Study ID Numbers: CAW-PMS-R01-01
• First Posted: April 13, 2021
• Last Update Posted: April 13, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Paclitaxel; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action