DES Versus BiOSS LIM - POLBOS II Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jacek Bil, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT02198300
First received: July 20, 2014
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary interventions (PCI) and are associated with higher rates of periprocedural complications as well as higher rates of in-stent restenosis and stent thrombosis. Provisional T-stenting (PTS) is the best treatment strategy at the moment. However, the optimal approach to coronary bifurcations treatment is still a subject of debate, especially when the side branch is large, not easily accessible and narrowed by a long lesion. One of the proposed alternatives are dedicated bifurcation stents (DBS). However, there is large scarcity of randomized trials with DBS. POLBOS II study is continuation of POLBOS I (POLish Bifurcation Optimal Stenting) study, in which paclitaxel-eluting stent BiOSS Expert® (Balton, Poland) was assessed. Now performance of sirolimus-eluting stent BiOSS LIM® (Balton, Poland) is verified.


Condition Intervention Phase
Coronary Artery Disease
Procedure: Coronary angioplasty with stent implantation
Drug: Dual antipletlet therapy (DAPT)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Regular Drug Eluting Stent Versus Dedicated Bifurcation Sirolimus-eluting Stent BiOSS LIM in Coronary Bifurcation Treatment - Randomized POLBOS II Study.

Further study details as provided by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland:

Primary Outcome Measures:
  • MACE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR)


Secondary Outcome Measures:
  • cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • all-cause death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • MI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    myocardial infarction

  • TLR [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    target lesion revascularization

  • TVR [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    target vessel revascularization

  • LLL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    late lumen loss


Enrollment: 202
Study Start Date: November 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rDES Group
regular drug-eluting stent implantation in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim
Procedure: Coronary angioplasty with stent implantation
Other Names:
  • device: LucChopin (Balton, Poland)
  • device: Xience (Abbot Vascular)
  • device: Promus (Boston Scientific)
  • device: Resolute Integrity (Medtronic)
  • device: Biomatrix (Biosensors)
  • device: Prolim (Balton, Poland)
Drug: Dual antipletlet therapy (DAPT)
DAPT given to each patient before stent implantation
Other Names:
  • acetysalicylic acid
  • clopidogrel
Experimental: BiOSS LIM Group
BiOSS LIM® stent implantation into coronary lesion within bifurcation.
Procedure: Coronary angioplasty with stent implantation
Other Names:
  • device: LucChopin (Balton, Poland)
  • device: Xience (Abbot Vascular)
  • device: Promus (Boston Scientific)
  • device: Resolute Integrity (Medtronic)
  • device: Biomatrix (Biosensors)
  • device: Prolim (Balton, Poland)
Drug: Dual antipletlet therapy (DAPT)
DAPT given to each patient before stent implantation
Other Names:
  • acetysalicylic acid
  • clopidogrel

Detailed Description:

After signing the informed consent patients were randomly assigned to one of two treatment strategies: BiOSS LIM® stent implantation or rDES implantation (envelope randomization, 1:1). If the patient was enrolled to rDES Group there was a second randomization: with or without final kissing ballooning (FKB). Clinical follow-up was performed with office visits or telephone contacts at 1 and 12 months after intervention. Adverse events were monitored throughout the study period. Follow-up coronary angiography was performed at 12 months unless clinically indicated earlier.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stable coronary artery disease (CAD) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS)
  • age ≥ 18 years old,
  • de novo coronary bifurcation lesion (including unprotected LMS),
  • MV diameter ≥ 2.5 mm and SB diameter ≥ 2.0 mm assessed by visual estimation.

Exclusion Criteria:

  • ST-elevation myocardial infarction (STEMI),
  • bifurcations with Medina type 0,0,1,
  • serum creatinine level ≥ 2.0 mg/dl,
  • inability to take dual antiplatelet therapy for 12 months,
  • left ejection fraction ≤ 30%
  • lack of an informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02198300

Locations
Poland
Central Clinical Hospital of the Ministry of Interior
Warsaw, Mazowieckie, Poland, 02-507
Sponsors and Collaborators
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Investigators
Principal Investigator: Robert J Gil, MD, PhD Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
  More Information

Publications:

Responsible Party: Jacek Bil, MD, PhD, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT02198300     History of Changes
Other Study ID Numbers: 2.1
Study First Received: July 20, 2014
Last Updated: July 21, 2014
Health Authority: Poland: Ministry of Health

Keywords provided by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland:
dedicated bifurcation stent
sirolimus eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 02, 2014