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A single-center, randomized, single-blind, controlled clinical study for the efficacy of jailed semi-inflated balloon technique and non-inflated balloon technique with coronary bifurcation lesions

A single-center, randomized, single-blind, controlled clinical study for the efficacy of jailed semi-inflated balloon technique and non-inflated balloon technique with coronary bifurcation lesions

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023770
Enrollment
Unknown
Registered
2019-06-11
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-06-17

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

Conditions

coronary heart disease

Interventions

experimental group:Jailed semi-inflated balloon technique
control group:jailed balloon technique

Sponsors

Department of cardiology, Union Hospital, Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients were eligible for the studies if they were 18 to 75 years old with complex coronary bifurcation lesions of V-RESOLVE score =12 undergoing PCI; 2. Coronary bifurcation lesions with an SB diameter = 2.0 mm based on visual estimation were included in the two groups.

Exclusion criteria

Exclusion criteria: 1, Subject with renal failure (serum creatinine > 2.0 mg/dl); 2, Subject exhibited severe left ventricular dysfunction (LVEF < 35%); 3, Subject with a serious comorbidity or with life expectancy < 1 year; 4, Subject exhibited contraindications to aspirin or clopidogrel.

Design outcomes

Primary

MeasureTime frame
the incidences of side branch;the occurrence of in-hospital MACEs;the total numbers of FKBI used;the probability of balloons and wires damaged or even broken;The incidence of perioperative myocardial infarction;

Secondary

MeasureTime frame
a composite of the rehospitalization rate due to angina pectoris and MACEs at 12 months;

Countries

china

Contacts

Public ContactYucheng Zhong
zyc811029@126.com+86 15872374991

Outcome results

None listed

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