BiOSS LIM C vs 2nd Generation DES in Non-LM Bifurcations

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03548272
• Date of registration: 24/05/2018
• Prospective Registration: Yes
• Primary sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
• Public title: BiOSS LIM C vs 2nd Generation DES in Non-LM Bifurcations POLBOS 3
• Scientific title: POLish Bifurcation Optimal Treatment Strategy (POLBOS 3) Randomized Study
• Date of first enrolment: June 12, 2018
• Target sample size: 518
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03548272
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Poland

Contacts

• Name: Robert J Gil, MD, PhD, FESC

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Intervention(s)

Procedure: Percutaneous Coronary Intervention with stent implantation

Primary Outcome(s)

MACE [Time Frame: 12 months]

Secondary Outcome(s)

All cause death [Time Frame: 12 months]

cardiac death [Time Frame: 12 months]

myocardial infarction [Time Frame: 12 months]

target lesion revascularization [Time Frame: 12 months]

Secondary ID(s)

1.00

Source(s) of Monetary Support

Please refer to primary and secondary sponsors