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

Coronary Artery Disease Clinical Trial

— POLBOS 3  

Official title:

POLish Bifurcation Optimal Treatment Strategy (POLBOS 3) Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03548272
• Other study ID #: 1.00
• Status: Recruiting
• Phase: Phase 4
• Start date: June 12, 2018
• Est. completion date: June 2020

Study information

• Verified date: July 2018
• Source: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Single stent implantation in the main vessel-main branch across a side branch is the default strategy (provisional T-stenting, PTS) in all patients enrolled. Bifurcation lesions are assessed according to Medina classification using an index of 1 for stenosis greater than 50% and 0 for no stenosis (visual estimation). There is no restriction regarding lesion length in patient selection. If required, additional stent can be implanted (Alex Plus in the BiOSS Lim C Group). A stent in a side branch (Alex Plus in the BiOSS Lim C Group) should be implanted only if there is proximal residual stenosis greater than 70% after balloon dilatation and/or significant flow impairment after main vessel - main branch stenting and/or a flow limiting dissection.

The implantation protocol for bifurcation is as follows:

1. wiring of both branches;

2. main vessel predilatation and/or side branch predilatation according to the operator's decision;

3. stent implantation (inflation for at least 20 s);

4. proximal optimization technique (POT)

5. side branch postdilatation/side branch stent implantation if necessary

6. final kissing balloon inflation at operator's discretion.

7. Second proximal optimization technique (re-POT)

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Percutaneous Coronary Intervention with stent implantation
PCI with BiOSS LIM C or rDES depending on the randomization

Locations

Country	Name	City	State
Poland	Department of Invasive Cardiology Central Clinical Hospital of the Ministry of Interior	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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

Outcome

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