Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KCRI
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons.
研究概览
简要总结
Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS.
Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly reduced. This is expected to result in better short- and long-term outcomes.
详细描述
Study design:
Following pre-dilatation a BVS will be implanted and optical coherence tomography (OCT) will be performed in all patients. After OCT post-dilatation with non-compliant balloons might be performed if this is considered necessary by the treating interventionist. Final OCT will be performed in all patients. 1:1 Randomization of two strategies before the implantation of bioresorbable scaffolds:
- OPN strategy (study group): pre-dilatation with OPN® NC (non-compliant) Super High Pressure PTCA (percutaneous transluminal coronary angioplasty) balloons
- standard strategy (control group): pre-dilatation with a standard (compliant) balloon
Enrolment:
Randomization of 50 patients
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
- None
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
- •Age > 18 years.
- •Able and willing to give informed consent.
- •Willing to comply with specified follow-up evaluations.
- •Clinical manifestation of coronary artery disease: stable angina, unstable angina or non-ST-elevation myocardial infarction.
- •De novo lesion.
- •Angiographic diameter stenosis > 70 % and/or fractional flow reserve <0.
- •Vessel diameter between 2.5 and 4.0 mm.
- •One- or two vessel disease (defined as diameter stenosis > 70 % in vessels with a diameter > 2.5 mm).
- •Up to two lesions in one or two vessels can be treated.
排除标准
- •Patient characteristics
- •Pregnant or nursing patient or planned pregnancy in the period up to 1 year following the index procedure.
- •Patient with contraindication for 12 months of dual antiplatelet therapy.
- •ST-elevation myocardial infarction.
- •Any contraindication to the implantation of BVS. Lesion characteristics
- •Visible thrombus in coronary angiography
- •Chronic total occlusion
研究组 & 干预措施
OPN strategy
The OPN NC Super High Pressure PTCA Balloon will be used as the study device for lesion preparation for BVS Absorb implantation - OPN strategy of lesion preparation. This balloon has a twin layer balloon construction, which allows a very high pressure resistance of 35 bar. The balloon has a 0.016'' lesion entry profile and is available in sizes between 1.5 and 4.5 mm and lengths of 10, 15 and 20 mm.
干预措施: OPN strategy (Device)
standard strategy
Predilatation with standard coronary balloon will be performed for lesion preparation for BVS Absorb implantation - standard strategy of lesion preparation.
干预措施: standard strategy (Device)
结局指标
主要结局
Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons.
时间窗: During the index procedure
Stent apposition will be assessed based on OCT (optical coherence tomography) visualization.
次要结局
- Procedural success defined as successful delivery of the scaffold.(During the index procedure)
- Need for post-dilatation after initial OCT.(During the index procedure)
- Scaffold apposition after post-dilatation.(During the index procedure)
- Periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation.(During the index procedure)
- Periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin).(During the index procedure)
- In-stent restenosis requiring revascularization within 12 months post-procedure.(12 months after the index procedure)
- Rate of stent thrombosis according the ARC (academic research consortium) criteria within 12 months post procedure.(12 months after the index procedure)
- Death or myocardial infarction within 12 months post procedure.(12 months after the index procedure)