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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

518 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-12

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)

NCT03508219

Coronary Stenosis

TERMINATED NA

POLish Bifurcation Optimal Stenting Study

NCT02192840

Coronary Artery Disease

COMPLETED PHASE4

BiOSS Study (BiOSS LIM C Stent Registry in Bifurcated Lesions)

NCT03475563

Coronary Artery Disease

UNKNOWN

Long-term Outcomes of Patients After Coronary Bifurcation Stenting

NCT00325884

Coronary Artery Disease Death Myocardial Infarction

COMPLETED

BOVAS: Bifurcation Optimal Viewing Angle Selection Study

NCT01300494

Coronary Bifurcation Lesion

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BiOSS LIM C

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).

Group Type EXPERIMENTAL

Percutaneous Coronary Intervention with stent implantation

Intervention Type PROCEDURE

PCI with BiOSS LIM C or rDES depending on the randomization

regular 2nd generation DES

Intervention: Percutaneous coronary intervention (PCI) with regular drug-eluting stent implantation (rDES).

rDES well-tested and available on the market. Xience, Orsiro, Resulte Integrity

Group Type ACTIVE_COMPARATOR

Percutaneous Coronary Intervention with stent implantation

Intervention Type PROCEDURE

PCI with BiOSS LIM C or rDES depending on the randomization

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Percutaneous Coronary Intervention with stent implantation

PCI with BiOSS LIM C or rDES depending on the randomization

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No