Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: DES; Device: paclitaxel DCB

• Registration Number: NCT04842838
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-09
• Last Update Submitted: 2021-04-09
• Study First Posted: 2021-04-13
• Last Update Posted: 2021-04-13
• Study Start: 2021-06-30
• Primary Completion: 2023-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DES strategy	DES	-
DCB strategy	paclitaxel DCB	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Target lesion failure (TLF)	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)	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

Name	Time	Method
Technical success rate	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
DAPT using time	1/6/12/24/36 month	The using time of DAPT
Clinical procedure time	during the procedure	The used time in the clinical procedure
Number of Participants with ARC defines stent thrombosis	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
Number of Participants with Bleeding events（BARC2, 3, and 5）	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
Number of Participants with Target lesion failure (TLF)	1/6/24/36 month	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)	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
Number of Participants with Target vessel revascularization (TVR)	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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China