Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds

Study Overview
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Brief Summary
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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
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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)

Official Title
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Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study

Conditions
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Coronary Artery Disease, Angina, Unstable, Angina, Stable

Intervention / Treatment
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* Device: OPN strategy
* Device: standard strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPN strategy<br>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. | Device: OPN strategy<br>* Predilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation.<br>|
| Active Comparator: standard strategy<br>Predilatation with standard coronary balloon will be performed for lesion preparation for BVS Absorb implantation - standard strategy of lesion preparation. | Device: standard strategy<br>* Predilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons. | Stent apposition will be assessed based on OCT (optical coherence tomography) visualization. | During the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success defined as successful delivery of the scaffold. | The frequency of procedural success will be compared in both study groups. | During the index procedure | 
| Need for post-dilatation after initial OCT. | The frequency of post-dilatation will be compared in both study groups. | During the index procedure | 
| Scaffold apposition after post-dilatation. | The scaffold apposition after post-dilatation will be compared based on OCT assessment in both study groups. | During the index procedure | 
| Periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation. | 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. | 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). | The frequency of periprocedural myocardial infarction will be compared in both study groups. | During the index procedure | 
| In-stent restenosis requiring revascularization within 12 months post-procedure. | The frequency of in-stent restenosis requiring revascularization will be compared in both study groups in 12 months follow-up. | 12 months after the index procedure | 
| Rate of stent thrombosis according the ARC (academic research consortium) criteria within 12 months post procedure. | The frequency of stent thrombosis will be compared in both study groups in 12 months follow-up. | 12 months after the index procedure | 
| Death or myocardial infarction within 12 months post procedure. | The frequency of death and myocardial infarction will be compared separately in both study groups in 12 months follow-up. | 12 months after the index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, OPN NC, Angina, Stable, Unstable