Skip to content

A Multicenter Randomized Controlled Trial of Jailed Balloon-Proximal Optimization Techniquein in True Coronary Bifurcation Lesions

A Multicenter Randomized Controlled Trial of Jailed Balloon-Proximal Optimization Techniquein in True Coronary Bifurcation Lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071356
Enrollment
Unknown
Registered
2023-05-12
Start date
2023-05-12
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

True Bifurcation of Coronary Artery

Interventions

group 1:Jailed Balloon-Proximal Optimization Techniquein
group 2:Traditional JWT

Sponsors

Department of Cardiology, Tangdu Hospital, Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Ages ranging from 18 to 90 years; 2. Coronary imaging confirming true non-LMB lesions (Medina classification: 1,1,1; 0,1,1; or 1,0,1), with MV diameter stenosis >= 70%, vessel diameter >= 2.5 mm, and SB diameter stenosis >= 50%, vessel diameter >=2.0 mm, TIMI pre-stent flow grade >= 1; 3. After comprehensive evaluation by the operator, the bifurcation lesion needs side branch protection, and patients scheduled for stepwise PS following comprehensive evaluation by physiologists; 4. The target vessel has no previous history of PCI and coronary artery bypass grafting (CABG); 5. Not participating in other research.

Exclusion criteria

Exclusion criteria: 1. Patients who are judged by the operator to be eligible for coronary artery bypass grafting. 2. In cases where mild calcification is detected during coronary angiography, further intravascular ultrasound (IVUS) examination is carried out. If the lesions on the side of the proximal main branch and side branch show that the calcification angle is greater than 90° and there are calcified nodules, as well as overly tortuous lesions. 3. Patients whose true bifurcation lesions are evaluated by the operator according to the DEFINITION criteria (1 major criterion: for non-left main bifurcation lesions, the length of the side branch lesion is >= 10mm and the diameter stenosis degree is >= 90%, combined with 2 of the 6 minor criteria including a reference diameter of the main branch vessel 70°, a main branch lesion length > 25mm, and lesions containing thrombus). In this trial, the first 2 minor criteria have been excluded, that is, if a patient meets 1 major criterion and at the same time satisfies 2 or more of the remaining 4 minor criteria, the lesion is considered a complex bifurcation lesion and will be excluded. 4. Patients who are allergic to aspirin, clopidogrel, or ticagrelor. 5. Patients with non-transient liver dysfunction, coagulation dysfunction, or a high bleeding risk. 6. Patients who are scheduled to undergo non-cardiac surgery within 1 year and need to discontinue the use of antiplatelet aggregation drugs. 7. Patients with other concurrent diseases and an expected lifespan of less than 3 months. 8. Pregnant patients. 9. Patients with severe mental disorders who are unable to cooperate with the surgery or subsequent follow-up.

Design outcomes

Primary

MeasureTime frame
Incidence of branch occlusion during PCI;

Secondary

MeasureTime frame
The incidence of branch reentry guide wire;Success rate of reentering branch guide wire;TIMI blood flow in main branches and branches after operation;The incidence of major adverse cardiovascular events during perioperative period and 12 months after surgery;Dose of contrast agent used;Gamma ray measurement is involved;Operation duration;

Countries

China

Contacts

Public ContactGuo Wangang

Air Force Medical University Tangdu Hospital

wg_guoxn@163.com+86 186 2958 1753

Outcome results

None listed

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