Optimal Predilatation Technique for BVS Implantation

Study Overview
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Brief Summary
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The purpose of this study is to determine the optimal way of predilatation for BVS implantation.

Detailed Description
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Randomized, single-center study. Forty-five patients with intended BVS implantation will be randomized in ratio of 1:1:1 to different predilatation strategies(non-compliant balloon/Emerge NC™, Boston Scientific, cutting balloon/Flexitome™, scoring balloon/Scoroflex™,Orbus). Predilatation is intended to be done in a vessel:balloon ratio of 1:1. If the device is not able enter the lesion, it will be replaced with a conventional semicompliant balloon with the same predilatation strategy (a vessel:balloon ratio of 1:1) After a successful predilatation, the BVS (Absorb™, Abbott) will be implanted and this procedure will be accomplished by a high pressure postdilatation with a non-compliant balloon (Emerge NC™, BSCI). The MLA of the Absorb stent will be evaluated with optical coherence tomography (OPTIS, St.Jude).

Official Title
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Optimal Predilatation Technique for BVS Implantation

Conditions
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Coronary Artery Stenosis

Intervention / Treatment
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* Device: Predilatation with non-compliant balloon
* Device: Predilatation with scoring balloon (Scoroflex)
* Device: Predilatation with cutting balloon (Flextome)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing percutaneous coronary intervention (PCI) lesion no more than 25 mm in length with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment Exclusion Criteria: patients with acurate myocardial infarction (STEMI) patients with specific complex lesion features (left main, aorto ostial, bifurcation with side branch ≥ 2 mm in diameter, extreme angulation proximal or within the target lesion, moderate or heavy calcification proximal or within the target lesion, 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 |
| --- | --- |
| Active Comparator: Non-compliant balloon<br>15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon | Device: Predilatation with non-compliant balloon<br>* Coronary artery stenosis is dilated before BVS implantation with the use of non-compliant balloon (standard procedure). Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)<br>|
| Experimental: Scoring balloon<br>15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon | Device: Predilatation with scoring balloon (Scoroflex)<br>* Coronary artery stenosis is dilated before BVS implantation with the use of scoring balloon. Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)<br>|
| Experimental: Cutting balloon<br>15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon | Device: Predilatation with cutting balloon (Flextome)<br>* Coronary artery stenosis is dilated before BVS implantation with the use of cutting balloon. Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal lumen area (MLA) in the BVS (mm2) | After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area. | Immediately after BVS implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically - driven target vessel revascularization | Patient is followed after BVS implantation in 1,6 and 12 months in the outpatient department. | 12 months after the procedure | 
| Eccentricity index | After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area. Eccentricity index is calculated as minimal luminal diameter divided by maximal luminal diameter in the MLA segment. | Immediately after BVS implantation | 
| Expansion index | After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area. Expansion index is calculated as minimal luminal diameter divided by maximal expected diameter of the non-compliant balloon used for high pressure postdilatation. | Immediately after BVS implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, bioabsorbable scaffold