Skip to content

A prospective, single-center, randomized controlled study of DCB-only and main stent implantation stent branch drug balloon dilatation strategy in the treatment of true bifurcation of coronary artery disease

A prospective, single-center, randomized controlled study of DCB-only and main stent implantation stent branch drug balloon dilatation strategy in the treatment of true bifurcation of coronary artery disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044080
Enrollment
Unknown
Registered
2021-03-09
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-07-21

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

Conditions

coronary artery disease

Interventions

experimental group:DCB-only
control group:The main branch was implanted with stent, and the branch was treated with drug balloon.

Sponsors

China-Japan Union Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: The eligible patients were male and non-pregnant female patients with true coronary bifurcation disease (Medina type 1,1,1;1,0,1;0,1,1) Branch diameter 2.0-3.5mm, stenosis >= 70%, length = grade 3; branch residual stenosis < 50% after pretreatment.

Exclusion criteria

Exclusion criteria: 1. Unprotected left main artery disease and its branches; 2. In-stent restenosis; 3. Severe calcification or unsuitable balloon dilatation; 4. Life expectancy less than 1 year; 5. Severe heart failure (NYHA heart function grade, heart function >= III) or left ventricular ejection fraction < 35%; 6. Unable to tolerate dual antiplatelet therapy for 12 months; 7. Higher risk of bleeding (patients with high risk and above risk grades were excluded by CRUSADE score). 8. It is not possible to provide written informed consent.

Design outcomes

Primary

MeasureTime frame
late lumen loss;Branch opening area;

Secondary

MeasureTime frame
MACE(major adverse cardiac enents) during follow-up;

Countries

China

Contacts

Public ContactYuquan He

China-Japan Union Hospital of Jilin University

hyq2@sina.com+86 13944145413

Outcome results

None listed

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