DES Versus BiOSS LIM - POLBOS II Study

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rDES Group

regular drug-eluting stent implantation in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim

Group Type ACTIVE_COMPARATOR

Coronary angioplasty with stent implantation

Intervention Type PROCEDURE

Dual antipletlet therapy (DAPT)

Intervention Type DRUG

DAPT given to each patient before stent implantation

BiOSS LIM Group

BiOSS LIM® stent implantation into coronary lesion within bifurcation.

Group Type EXPERIMENTAL

Coronary angioplasty with stent implantation

Intervention Type PROCEDURE

Dual antipletlet therapy (DAPT)

Intervention Type DRUG

DAPT given to each patient before stent implantation

Interventions

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Coronary angioplasty with stent implantation

Intervention Type PROCEDURE

Dual antipletlet therapy (DAPT)

DAPT given to each patient before stent implantation

Intervention Type DRUG

Other Intervention Names

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device: LucChopin (Balton, Poland) device: Xience (Abbot Vascular) device: Promus (Boston Scientific) device: Resolute Integrity (Medtronic) device: Biomatrix (Biosensors) device: Prolim (Balton, Poland) acetysalicylic acid clopidogrel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No