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Comparison of Ostial Optimization Versus Proximal Optimization and Its Related Techniques for Treatment of Side-Branch Ostium Following Main-Branch Stenting of Coronary Bifurcation Lesions: a Single Center Randomized Controlled Trial

Comparison of Ostial Optimization Versus Proximal Optimization and Its Related Techniques for Treatment of Side-Branch Ostium Following Main-Branch Stenting of Coronary Bifurcation Lesions: a Single Center Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030749
Enrollment
Unknown
Registered
2020-03-13
Start date
2020-04-01
Completion date
Unknown
Last updated
2020-03-16

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:POT and its related techniques(POT-kissing-POT and POT-side-POT)
control group:OOT technique

Sponsors

Union Hospital Affiliated to Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged > 18 and 2.5 mm and the side-branch > 2.25 mm by visually angiographic estimation; 4. The lesion is suitable for PCI (if the left main trunk bifurcated lesion, SYNTAX score <= 32), and if necessary, the lesion is suitable for double stent implantation; 5. Patients willing to participating and following up; 6. Patients (or legal guardian) understanding the trial protocol and requirement with written consent.

Exclusion criteria

Exclusion criteria: 1. Chronic total occlusion with either of branches unable to recanalization, severely calcified bifurcation lesion requiring rotablation; 2. Patients Intolerance to dual-antiplatelet therapy; 3. Patients with obvious hemopoietic system abnormalities, for instances, plt 700*10^9/L, white count 5 URL)or renal dysfunction (eGR F> 30ml/min/1.73m2), congestive heart failure (NYHA > III) etc. 6. Severe illness with life expectance of <= 12 months, for instances, cancers, other end-stage deceases; 7. Women with or planning to pregnancy; 8. Patients with contraindications or allergies to the stent platforms or the associated medications, for instances, stent eluting drugs, stainless steel or alloy, aspirin, P2Y12 inhibitors, contrast agents, etc.; 9. Patients participating another drug or instrument ongoing trial, or planning to participate another drug or instrument trial within 12 month post-procedurally.

Design outcomes

Primary

MeasureTime frame
the composite rate of the target lesion failure (TLF) including cardiac death, myocardial infarction (Q- or non-Q-wave) and ischemic target lesion revascularization (iTLR).;

Secondary

MeasureTime frame
acute loss side branch during procedure;Emergency target lesions revascularization and acute in-stent thrombosis (IST) during perioperative or hospitalization;;Procedure-related myocardial necrotic biomarkers release and elevation according to the third universal definition of myocardial infarction.;The incidence of major adverse cardiovascular events (MACE) 12 months after PCI procedure;, including cardiac death, myocardial infarction (Q wave or non-Q wave), in-stent thrombosis (IST) and ischemic target lesion revascularization (iTLR);The rate of in-stent and in-segment restenosis of the MB and SB 12 months after PCI procedure;All-cause death, myocardial infarction and any vascular remodeling (including target lesions, target and non-target vascular revascularization) 12 months after PCI procedure;ARC defined in-stent thrombosis (IST) including acute, subacute, late and very late IST;Cardiac function graded by the New York Heart Association (NYHA);Stable angina grading by Canadian Cardiovascular Society (CCS) or unstable angina by Braunwald;

Countries

China

Contacts

Public ContactChen Lianglong

Union Hospital Affiliated to Fujian Medical University

lianglongchenfjj@126.com+86 13365910396

Outcome results

None listed

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