Bifurcation ABSORB OCT Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort A
研究概览
简要总结
The Bifurcation ABSORB OCT Trial is a prospective, randomized (1:1) evaluation of the efficacy and performance of single ABSORB everolimus eluting bioresorbable vascular scaffold provisional strategy in the treatment of (a) coronary bifurcation lesion(s) in consecutive subjects with and without fenestration towards the side branch.
Patients included in this study will be divided into three different cohorts:
- Cohort A (patient 1-20): Angiographic FU with OCT at 12 months.
- Cohort B (patient 21-40): Angiographic FU with OCT at 24 months.
- Cohort C (patient 41-60): Angiographic FU with OCT at 36 months.
All patients will also have telephone FU at 30 days, 12, 24 and 36 months.
Inclusion of patients in the BISORB OCT trial stopped in November 2016 after safety concerns of the ABSORB BVS were reported. BISORB OCT included 3 patients, which were all included in the Academic Medical Center
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a bifurcation lesion involving a side-branch larger than 2 mm and having main branch involvement (Medina 0,0,1 lesions are excluded).
- •Subject must agree to undergo all clinical investigation plan-required follow-up visits and to undergo follow-up angiography and optical coherence tomography.
- •Subject is able to verbally confirm understanding and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure,as approved by the appropriate Ethics Committee.
排除标准
- •Subject is younger than 18 years of age
- •Subject is presenting with a STEMI
- •Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
- •Subject has known hypersensitivity or contraindication to contrast, aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
- •Known renal insufficiency (eg. estimated Glomerular Filtration Rate (eGFR) <60mL/min/1.73m2 or serum creatinine level of >2.5mg/dL or subject on dialysis)
- •Subject with a limited life expectancy less than one year.
- •Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or subject unable to read or write.
研究组 & 干预措施
No Fenestration
No fenestration of the Absorb Biovascular Scaffold towards the side-branch
干预措施: ABSORB BVS (Device)
Fenestration
Fenestration of the Absorb Biovascular Scaffold towards the side-branch
干预措施: ABSORB BVS (Device)
结局指标
主要结局
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort A
时间窗: 12 months
3D reconstruction assessment is done visually and the number of strut free compartments are categorized as follows: Non-jailed side branch or jailed side branch. Non-jailed side branch is defined as either no strut over the sidebranch is present or 1 of the BVS struts is present over the side branch but does not compartmentalize the side branch. Jailed side branch is defined as the BVS struts separate the side branch ostium into n compartments. The distribution of the struts creates different patterns of compartments: V, T, H, double V, double T, and double H.
次要结局
- Tissue in-between non-apposed side branch (NASB) struts - Cohort A(12 months)
- The number of non-apposed side branch (NASB) struts - All cohorts(Baseline)
- The number of non-apposed side branch (NASB) struts - Cohort A(12 months)
- The number of non-apposed side branch (NASB) struts - Cohort B(24 months)
- Tissue in-between non-apposed side branch (NASB) struts - Cohort C(36 months)
- Mean/Minimal Lumen diameter/area - Cohort A(12 months)
- Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - All cohorts(Baseline)
- Incomplete strut apposition in the bifurcation region - Cohort A(12 months)
- Incomplete strut apposition in the bifurcation region - Cohort C(36 months)
- Number of embedded and protruded ABSORB BVS struts per region - All cohorts(Baseline)
- Incomplete strut coverage in the bifurcation region - Cohort A(12 months)
- Incomplete strut apposition in the bifurcation region - All cohorts(Baseline)
- Number of embedded and protruded ABSORB BVS struts per region - Cohort A(12 months)
- Number of embedded and protruded ABSORB BVS struts per region - Cohort B(24 months)
- Number of embedded and protruded ABSORB BVS struts per region - Cohort C(36 months)
- Mean/Minimal Lumen diameter/area - Cohort C(36 months)
- Mean/Minimal Scaffold diameter/area - Cohort A(12 months)
- Neointima thickness - Cohort C(36 months)
- Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort B(24 months)
- Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort C(36 months)
- Incomplete strut apposition in the bifurcation region - Cohort B(24 months)
- Incomplete strut coverage in the bifurcation region - Cohort B(24 months)
- Incomplete strut coverage in the bifurcation region - Cohort C(36 months)
- Mean/Minimal Lumen diameter/area - Cohort B(24 months)
- The number of non-apposed side branch (NASB) struts - Cohort C(36 months)
- Neointima thickness - Cohort A(12 months)
- Scaffold pattern irregularities - All cohorts(Baseline)
- Scaffold pattern irregularities - Cohort B(24 months)
- Tissue in-between non-apposed side branch (NASB) struts - Cohort B(24 months)
- Mean/Minimal Lumen diameter/area - All cohorts(Baseline)
- Mean/Minimal Scaffold diameter/area - Cohort C(36 months)
- Scaffold pattern irregularities - Cohort C(36 months)
- Mean/Minimal Scaffold diameter/area - All cohorts(Baseline)
- Neointima thickness - Cohort B(24 months)
- Scaffold pattern irregularities - Cohort A(12 months)
- Mean/Minimal Scaffold diameter/area - Cohort B(24 months)
研究者
J.J. Wykrzykowska
MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)