Status:
UNKNOWN
Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy
Lead Sponsor:
Peking University Third Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04842838
Start Date
June 30 2021
End Date
June 30 2025
Last Update
April 13 2021
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China