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Comparison of The Efficacy of Jailed Balloon Inflation Or Not in Preventing Side Branch Occlusion in Non-left Coronary Main Bifurcation lesions:A Single-center Prospective Randomized Controlled Study

Comparison of The Efficacy of Jailed Balloon Inflation Or Not in Preventing Side Branch Occlusion in Non-left Coronary Main Bifurcation lesions:A Single-center Prospective Randomized Controlled Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079445
Enrollment
Unknown
Registered
2024-01-03
Start date
2024-01-04
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Coronary Artery Disease

Interventions

Inflation of Jailed Balloon:The jailed balloon inflates simultaneously with the main branch stenting.
Non-Inflation of Jailed Balloon :The jailed balloon do not inflate when the main branch stents.

Sponsors

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: 18-80 years old 2: Patients diagnosed with CAD who underwent coronary angiography (CAG) indicated =1 non-left main true bifurcation lesion (medina: 1.1.1, 1.0.1, 0.1.1), and this bifurcation lesion received main-branch single-stent strategy and the side branch received jailed balloon protection technology. 3: Sign informed consent

Exclusion criteria

Exclusion criteria: 1: Pregnant or lactating women 2: Thrombotic lesions 3: Severe coronary artery calcification, chronic complete occlusion disease (CTO) with true bifurcation 4: Left ventricular ejection fraction < 40% 5: severe hepatic and renal dysfunction 6: drug allergies of aspirin, P2Y12 receptor inhibitors, contrast agents and other 7: Planned surgery within six months 8: Diseases that may lead to a life expectancy of < 12 months (e.g. cancer, end-stage heart failure, etc.) 9: Long-term oral anticoagulant medication, or coagulation dysfunction 10: Currently participating in an investigational drug or device trial that has not completed its primary endpoint

Design outcomes

Primary

MeasureTime frame
Incidence of side branch occlusion immediately after main branch stenting and operation;

Secondary

MeasureTime frame
Dissection rate of the side branch orifice;TIMI flow of the main and side branch;Incidence of MACE events during hospitalization;

Countries

China

Contacts

Public ContactLongwei Li

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

llw3831@163.com+86 152 5515 6200

Outcome results

None listed

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