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Prospective single-center randomized controlled clinical trial of safety and efficacy of drug-coated balloon treating coronary true bifurcation

Prospective single-center randomized controlled clinical trial of safety and efficacy of drug-coated balloon treating coronary true bifurcation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059108
Enrollment
Unknown
Registered
2022-04-25
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Interventions

Group A:A drug balloon was used in the side vessel, followed by a drug eluting stent in the main vessel
Group B:A drug-eluting stent was used in the main vessel followed by a drug balloon in the side vessel
Group C:Both main and side branches were treated with drug balloon

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with stable angina pectoris, unstable angina pectoris or acute non-ST-segment elevation myocardial infarction; 2. De novo true coronary bifurcation lesions (including Medina 1,1,1, 1,0,1, 0,1,1); 3. Main vessel diameter >= 2.25mm, diameter stenosis rate >=70%; The diameter of side vessels was >=2.0 mm, and the diameter stenosis rate was >=50%; 4. After pretreatment, residual stenosis of vessels was less than 50%, no type C or above dissection, and TIMI blood flow level 3.

Exclusion criteria

Exclusion criteria: 1. Aged =III) or left ventricular ejection fraction <35%; 8. Life expectancy <12 months.

Design outcomes

Primary

MeasureTime frame
Rate of late lumen loss and diameter narrowing of main and branch;

Secondary

MeasureTime frame
Acute vascular occlusion;Incidence of major cardiac adverse events;Target vessel failure rate;

Countries

China

Contacts

Public ContactWu Zheng

Beijing Anzhen Hospital, Capital Medical University

zhengwu1@hotmail.com+86 13901333309

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026