Angina, Stable, Angina, Unstable, Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, OPN NC, Angina, Stable, Unstable
Brief summary
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.
Detailed description
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 * 25 in the OPN strategy (study group) * 25 in the standard strategy (control group)
Interventions
DEVICEOPN strategy
Predilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation.
DEVICEstandard strategy
Predilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation.
Sponsors
SIS Medical AG
KCRI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 \<0.80. * 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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons. | During the index procedure | Stent apposition will be assessed based on OCT (optical coherence tomography) visualization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for post-dilatation after initial OCT. | During the index procedure | The frequency of post-dilatation will be compared in both study groups. |
| Scaffold apposition after post-dilatation. | During the index procedure | The scaffold apposition after post-dilatation will be compared based on OCT assessment in both study groups. |
| Periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation. | During the index procedure | The frequency of periprocedural complications as dissection, slow-flow, no flow and dissection requiring additional stent implantation will be compared separately in both study group. |
| Procedural success defined as successful delivery of the scaffold. | During the index procedure | The frequency of procedural success will be compared in both study groups. |
| In-stent restenosis requiring revascularization within 12 months post-procedure. | 12 months after the index procedure | The frequency of in-stent restenosis requiring revascularization will be compared in both study groups in 12 months follow-up. |
| Rate of stent thrombosis according the ARC (academic research consortium) criteria within 12 months post procedure. | 12 months after the index procedure | The frequency of stent thrombosis will be compared in both study groups in 12 months follow-up. |
| Death or myocardial infarction within 12 months post procedure. | 12 months after the index procedure | The frequency of death and myocardial infarction will be compared separately in both study groups in 12 months follow-up. |
| 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 | The frequency of periprocedural myocardial infarction will be compared in both study groups. |
Countries
Switzerland
Outcome results
None listed