Coronary Artery Disease Clinical Trial
— POLBOS 3Official title:
POLish Bifurcation Optimal Treatment Strategy (POLBOS 3) Randomized Study
NCT number | NCT03548272 |
Other study ID # | 1.00 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 12, 2018 |
Est. completion date | June 2020 |
Coronary bifurcations are encountered in about 15 - 20% of percutaneous coronary interventions (PCI). They are considered technically challenging and associated with worse clinical outcomes than non-bifurcation lesions. Percutaneous coronary intervention (PCI) to the target bifurcation lesion. Randomization (by means envelope randomization) to investigational device: Group 1 for BiOSS LIM C implantation vs Group 2 for any DES implantation.
Status | Recruiting |
Enrollment | 518 |
Est. completion date | June 2020 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Subject at least 18 years of age. 2. Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. 3. Target main branch lesion(s) located in a native coronary artery with diameter of = 2.5 mm and = 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of = 2.0 mm. 4. Target lesion(s) amenable for PCI with balloon angioplasty of the side branch. Exclusion Criteria: 1. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment). 2. Subjects who refuse to give informed consent. 3. Subjects with LVEF<30% 4. Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy 5. Distal LM stenosis |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Invasive Cardiology Central Clinical Hospital of the Ministry of Interior | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland |
Poland,
1. Latib A, Colombo A, Sangiorgi GM. Bifurcation stenting: current strategies and new devices. Heart. 2009; 95(6): 495-504. 2. Lassen JF, Holm NR, Stankovic G, et al. Percutaneous coronary intervention for coronary bifurcation disease: consensus from the
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MACE | Major Cardiovascular Events rate (cardiac death, myocardial infarction, target lesion revascularization); | 12 months | |
Secondary | All cause death | All cause death | 12 months | |
Secondary | cardiac death | cardiac death | 12 months | |
Secondary | myocardial infarction | myocardial infarction | 12 months | |
Secondary | target lesion revascularization | target lesion revascularization | 12 months |
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