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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Percutaneous Coronary Intervention with stent implantation

• Registration Number: NCT03548272
• Lead Sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Brief 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.

Detailed 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)

Study Timeline

• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-07
• Study Start: 2018-06-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-19
• Primary Completion: 2019-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 518

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BiOSS LIM C	Percutaneous Coronary Intervention with stent implantation	Intervention: Percutaneous coronary intervention (PCI) with BiOSS LIM C stent implantation. The BiOSS LIM C® is a dedicated bifurcation balloon expandable stent made of cobalt-chromium alloy (strut thickness 70 µm) releasing sirolimus (1.4 µg/mm2) from the surface of a biodegradable coating comprised of a copolymer of lactic and glycolic acids (PGLA). The degradation of the polymer lasts approximately 8 weeks. The BiOSS LIM C® stent consists of two main separate parts with different diameters: wider proximally, and distally smaller. The proximal part is always a bit shorter than the distal one (avg. 1 mm).
regular 2nd generation DES	Percutaneous Coronary Intervention with stent implantation	Intervention: Percutaneous coronary intervention (PCI) with regular drug-eluting stent implantation (rDES). rDES well-tested and available on the market. Xience, Orsiro, Resulte Integrity

Primary Outcome Measures

Name	Time	Method
MACE	12 months	Major Cardiovascular Events rate (cardiac death, myocardial infarction, target lesion revascularization);

Secondary Outcome Measures

Name	Time	Method
All cause death	12 months	All cause death
cardiac death	12 months	cardiac death
myocardial infarction	12 months	myocardial infarction
target lesion revascularization	12 months	target lesion revascularization

Trial Locations

Locations (1)

Department of Invasive Cardiology Central Clinical Hospital of the Ministry of Interior; 🇵🇱 Warsaw, Poland