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

Peking University

Status: Not yet enrolling

Conditions: Coronary Artery Disease

Treatments: Device: paclitaxel DCB; Device: DES

Study type: Interventional

Funder types: Other

Identifiers

NCT04842838

CAW-PMS-R01-01

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

DCB strategy

Experimental group

Treatment:

Device: paclitaxel DCB

DES strategy

Active Comparator group

Treatment:

Device: DES