BIfurcation Optimal Treatment Strategy With LYMus Eluting Dedicated Bifurcation Versus Convention Stent Randomized Study

NCT01430364 | Unknown Phase 4 DMC

• 1 other identifier: BIOSS LIM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Study aims: to compare two intervention strategies for bifurcation treatment - provisional T-stenting (PTS) with drug-eluting stent (sirolimus eluting), with kissing balloon inflation at the end of procedure - the best treatment strategy at the moment, with stenting of bifurcation lesions with dedicated bifurcation drug-eluting stent BiOSS Lym.

Conditions

Coronary Bifurcation Stenosis

Keywords

coronary bifurcation stenosis; dedicated bifurcation stent; sirolymus; PTS; BiOSS Lym

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events (MACE)

  death, myocardial infarction (MI), target vessel revascularization (TVR)

  12 months

Secondary Outcomes (1)

• Target lesion revascularization (TLR)

  12 months

Study Arms (1)

BIOSS implantation

ACTIVE COMPARATOR

Device: BIOSS LIM implantation; Device: BIOSS Lim; Device: CarloS

Interventions

BIOSS LIM implantation DEVICE

BIOSS LIM is a dedicated bifurcation stent system with sirolymus elution.

BIOSS implantation

BIOSS Lim DEVICE

BIOSS implantation

CarloS DEVICE

BIOSS implantation

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject at least 18 years of age.
• 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.
• 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.
• Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.

You may not qualify if:

• STEMI
• 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).
• Subjects who refuse to give informed consent.
• Subjects with LVEF\<30%
• Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy
• Contraindications for 12 months DAP

Sponsors & Collaborators

• Medica Cor Heart Hospital: lead

Study Sites (1)

Medica Cor Heart Hospital

Rousse, 7000, Bulgaria

RECRUITING

Central Study Contacts

Dobrin Vassilev, MD, PhD

CONTACT

00359886846550; dobrinv@gmail.com

Kristiyan Ivanov, MD

CONTACT

00359884460101; kristik@abv.bg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2011
• First Posted: September 8, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: December 25, 2013

Record last verified: 2013-12

Locations

BU (1)