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The Bioresorbable Implants for Scaffolding Obstructions in Randomized Bifurcations (BIFSORB) Study (BIFSORB)

2021年1月5日 更新者：Evald Hoej Christiansen、Aarhus University Hospital Skejby

Bioresorbable Vascular Stents for Treatment of Coronary Bifurcation Lesions Assessed by Optical Coherence Tomography - The BIFSORB Study

Coronary artery disease is often treated by implantation of permanent metallic stents.Coronary stents are required in the early healing phase after balloon dilatation but constitute a lifelong foreign body. New bioresorbable stents have been developed and are believed to improve long-term safety. The purpose of this study is to compare the safety and vessel healing after treatment of simple bifurcation lesions with the CE-marked bioresorbable stents Absorb and Desolve.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

BIFSORB is a prospective, randomized multicenter trial comparing 6-month healing outcome after treatment of simple coronary bifurcation lesions by Absorb or Desolve BRS. for treatment of coronary bifurcation lesions.

BRS are promising in treatment of coronary artery disease. The concept of bifurcation treatment using BRS is particular appealing as struts covering the side branch ostium may resorb over time.

The aim of this study is to compare the 6 months safety and vessel healing after treatment of coronary bifurcation lesions by the Desolve or Absorb BRS.

Hypothesis: Treatment of coronary bifurcation lesions using Absorb and Desolve bioresorbable stents is safe. Treatment of coronary bifurcation lesions by Desolve BRS is associated with a lower index of adverse vessel wall features (main vessel area stenosis, acquired malapposition, evaginations, late recoil, single end attached protruding struts, side branch ostial area stenosis) at 6 months compared to treatment with Absorb BRS.

Methods:

Prospective, open label, single blind, randomized, feasibility and safety pilot study with inclusion of 120 patients. Randomization 1:1 to Absorb or Desolve. Planned 6- and 24-month follow-up by OCT and follow-up for clinical endpoints until 10 years.

Eligible patients with a bifurcation lesion are treated by the provisional technique with mandatory jailing of the side branch and provisional opening of side branch ostium by the mini-kiss technique in case of severe pinching or TIMI-flow less than III. Proximal post-dilatation is mandatory. No dilatation beyond the expansion limits of the BRS.

The patients are assessed by optical coherence tomography (OCT) before, during and after implantation of the Absorb or Desolve BRS at baseline procedure and again at 6- and 24-month follow-up, or before if they are readmitted with a possible target lesion failure.

The operator is not blinded to pre-PCI OCT images that may be used for sizing and positioning of the scaffolds. Procedural OCT may be used to optimize scaffold implantation before performing final OCT.

Results are reported as clinical safety at 6 months (myocardial infarction, revascularization, death) and stent healing index by OCT including malapposition, stent coverage, side branch ostial area late loss, fracture and evaginations.

研究类型

介入性

注册 (预期的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Aarhus N、丹麦、8200
        • Aarhus University Hospital
      • Odense、丹麦
        • Odense University Hospital
      • Roskilde、丹麦
        • Zealand University Hospital, Roskilde
  • 拉脱维亚
      • Riga、拉脱维亚
        • Latvian Heart Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Stable angina pectoris
  • Age > 18 years
  • Stabilized non-ST elevation myocardial infarction
  • Silent angina
  • De novo coronary bifurcation lesions at LAD/diagonal, CX/obtuse marginal, RCA-PDA/posterolateral branch
  • All Medina classes except Medina x.x.1
  • Diameter of side branch ≥ 2.5 mm
  • Signed informed consent

Exclusion Criteria:

  • ST-elevation infarction within 48 hours
  • Expected survival < 1 year
  • Severe heart failure (NYHA≥III)
  • S-creatinine > 120 µmol/L
  • Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine, everolimus or novolimus
  • Unable to cover main vessel lesion with one scaffold
  • Severe tortuosity
  • Severe calcification

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Absorb
Randomization to implantation of Absorb BVS in bifurcation lesion
设备：Absorb
Randomization to implantation of Absorb BVS in bifurcation lesion
实验性的：Desolve
Randomization to implantation of Desolve BRS in bifurcation lesion
设备：Desolve
Randomization to implantation of Desolve BRS in bifurcation lesion

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of participants with Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.
大体时间：6 months
Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.
6 months
Index of adverse vessel wall features
大体时间：6 months
Side branch ostial area late loss, strut fracture, uncovered non-side branch apposed stent struts, uncovered stent struts in front of side branch, uncovered stent struts on acquired or persistent malapposed struts, persistent malapposition, max neointimal thickness/area stenosis, cumulated extra stent lumen gain
6 months

次要结果测量

结果测量
措施说明
大体时间
光学相干断层扫描终点：支柱上的急性血栓
大体时间：基线
基线
血管造影终点：主血管支架置入后孔口侧支急性增益
大体时间：基线
基线
血管造影终点：主血管支架置入术后远端主血管口急性增益
大体时间：基线
基线
血管造影终点：主血管支架置入术后近端主血管急性增益
大体时间：基线
基线
Optical coherence tomography endpoint: acute malapposition
大体时间：Baseline
Baseline
Optical coherence tomography endpoint: acquired malapposition
大体时间：6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: persistent malapposition
大体时间：6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: Coverage of jailing struts
大体时间：6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: Extra stent lumen (including evaginations)
大体时间：Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Late stent recoil
大体时间：6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: stent fracture
大体时间：Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts
大体时间：Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Ostial strut loss
大体时间：Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Mean neointimal thickness
大体时间：6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: Stent strut coverage
大体时间：6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: Minimal luminal area in segmental analysis
大体时间：Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Minimal stent area in segmental analysis
大体时间：Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Minimum scaffold expansion area %
大体时间：Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Segmental area stenosis
大体时间：Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Healing above calcified plaque
大体时间：6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: Healing above lipid plaque
大体时间：6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: Late thrombus on struts
大体时间：6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: Acute expansion
大体时间：Baseline
Measured in segments with; 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation
Baseline
Optical coherence tomography endpoint:Late recoil
大体时间：6 and 24 months
Measured in segments with; 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation
6 and 24 months
Angiographic endpoint: Ostial side branch area stenosis
大体时间：Baseline, 6 and 24 months
Baseline, 6 and 24 months
Angiographic endpoint: Ostial side branch late loss
大体时间：6 and 24 months
6 and 24 months
Angiographic endpoint: Ostial distal main vessel area stenosis
大体时间：Baseline, 6 and 24 months
Baseline, 6 and 24 months
Angiographic endpoint: Ostial distal main vessel late loss
大体时间：6 and 24 months
6 and 24 months
Angiographic endpoint: Proximal main vessel area stenosis
大体时间：Baseline, 6 and 24 months
Baseline, 6 and 24 months
Angiographic endpoint: Proximal main vessel late loss
大体时间：6 and 24 months
6 and 24 months
Angiographic endpoint: Minimal luminal area of all segments
大体时间：Baseline, 6 and 24 months
Baseline, 6 and 24 months
Procedural endpoints: Procedure time
大体时间：Baseline
From sheath insertion to closure device excluding treatment of other vessels
Baseline
Procedural endpoints: Contrast use
大体时间：Baseline
Baseline
Procedural endpoints: Fluoroscopy time
大体时间：Baseline
Baseline

其他结果措施

结果测量
大体时间
Clinical endpoints: Myocardial infarction
大体时间：10 years
10 years
Clinical endpoints: Target lesion failure
大体时间：10 years
10 years
Clinical endpoints: Target lesion revascularization
大体时间：10 years
10 years
Clinical endpoints: Stent thrombosis
大体时间：10 years
10 years
Clinical endpoints: Cardiac death
大体时间：10 years
10 years
Clinical endpoints: Non-Cardiac death
大体时间：10 years
10 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Aarhus University Hospital Skejby

调查人员

  • 首席研究员：Evald H Christiansen, MD, PhD、Aarhus University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年1月1日

初级完成 (预期的)

2026年11月1日

研究完成 (预期的)

2028年9月1日

研究注册日期

首次提交

2016年11月22日

首先提交符合 QC 标准的

2016年11月22日

首次发布 (估计)

2016年11月25日

研究记录更新

最后更新发布 (实际的)

2021年1月6日

上次提交的符合 QC 标准的更新

2021年1月5日

最后验证

2021年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 1-10-72-215-14

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

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