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

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 (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.

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 ® 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 Angina

Intervention / Treatment
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* Device: Predilatation with OPN NC balloon catheter.
* Device: Predilatation with standard compliant balloon.
* Device: Absorb BVS implantation.
* Procedure: Treated segment visualization by OCT.
* Other: Clinical FU at 12 months.


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 |
| --- | --- |
| Other: OPN strategy (study group)<br>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. | Device: Predilatation with OPN NC balloon catheter.<br>* Target lesion will be prepared by predilatation with OPN NC balloon catheter.<br>Device: Absorb BVS implantation.<br>* After lesion preparation implantation of BVS Absorb scaffold will be performed.<br>Procedure: Treated segment visualization by OCT.<br>* Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).<br>Other: Clinical FU at 12 months.<br>* All patients will be clinically followed for 12 months.<br>|
| Other: Standard strategy (control group)<br>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. | Device: Predilatation with standard compliant balloon.<br>* Target lesion will be prepared by predilatation with standard balloon catheter (compliant).<br>Device: Absorb BVS implantation.<br>* After lesion preparation implantation of BVS Absorb scaffold will be performed.<br>Procedure: Treated segment visualization by OCT.<br>* Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).<br>Other: Clinical FU at 12 months.<br>* All patients will be clinically followed for 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section | Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure. | Participants will be followed for the duration of index procedure, an expected average of 1 hour. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| Scaffold apposition after post-dilatation | Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure. | 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. | 

 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