Clinical trial NCT04842838: Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy
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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants with Target lesion failure (TLF)
timeFrame: 12 months
measure: Number of Participants with net adverse clinical cardiovascular events (NACCE)
timeFrame: 12 months
Secondary outcomes:
measure: Technical success rate
timeFrame: 1-2 days
measure: Number of Participants with Target lesion failure (TLF)
timeFrame: 1/6/24/36 month
measure: Number of Participants with Target lesion revascularization (TLR)
timeFrame: 1/6/12/24/36 month
measure: Number of Participants with Target vessel revascularization (TVR)
timeFrame: 1/6/12/24/36 month
measure: Clinical procedure time
timeFrame: during the procedure
measure: DAPT using time
timeFrame: 1/6/12/24/36 month
measure: Number of Participants with Bleeding events（BARC2, 3, and 5）
timeFrame: 1/6/12/24/36 month
measure: Number of Participants with ARC defines stent thrombosis
timeFrame: 1/6/12/24/36 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: