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
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section
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 (Bioresorbable Vascular Scaffold).
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 ® 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 (study group)
Interventions planned in this arm are as follows:
- Predilatation with OPN NC balloon catheter.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
干预措施: Predilatation with OPN NC balloon catheter. (Device)
OPN strategy (study group)
Interventions planned in this arm are as follows:
- Predilatation with OPN NC balloon catheter.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
干预措施: Absorb BVS implantation. (Device)
OPN strategy (study group)
Interventions planned in this arm are as follows:
- Predilatation with OPN NC balloon catheter.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
干预措施: Treated segment visualization by OCT. (Procedure)
OPN strategy (study group)
Interventions planned in this arm are as follows:
- Predilatation with OPN NC balloon catheter.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
干预措施: Clinical FU at 12 months. (Other)
Standard strategy (control group)
Interventions planned in this arm are as follows:
- Predilatation with standard compliant balloon.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
干预措施: Predilatation with standard compliant balloon. (Device)
Standard strategy (control group)
Interventions planned in this arm are as follows:
- Predilatation with standard compliant balloon.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
干预措施: Absorb BVS implantation. (Device)
Standard strategy (control group)
Interventions planned in this arm are as follows:
- Predilatation with standard compliant balloon.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
干预措施: Treated segment visualization by OCT. (Procedure)
Standard strategy (control group)
Interventions planned in this arm are as follows:
- Predilatation with standard compliant balloon.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
干预措施: Clinical FU at 12 months. (Other)
结局指标
主要结局
Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section
时间窗: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.
次要结局
- Need for post-dilatation after implantation of the scaffold(Participants will be followed for the duration of index procedure, an expected average of 1 hour.)
- Procedural success defined as successful delivery of the scaffold(Participants will be followed for the duration of index procedure, an expected average of 1 hour.)
- Scaffold apposition after post-dilatation(Participants will be followed for the duration of index procedure, an expected average of 1 hour.)
- Frequency and total number of periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation,(Participants will be followed for the duration of index procedure, an expected average of 1 hour.)