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The purpose of this study is to determine the optimal way of predilatation for BVS implantation.
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 NCâ„¢, Boston Scientific, cutting balloon/Flexitomeâ„¢, scoring balloon/Scoroflexâ„¢,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 (Absorbâ„¢, Abbott) will be implanted and this procedure will be accomplished by a high pressure postdilatation with a non-compliant balloon (Emerge NCâ„¢, BSCI). The MLA of the Absorb stent will be evaluated with optical coherence tomography (OPTIS, St.Jude).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-compliant balloon | Active Comparator | 15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon |
|
| Scoring balloon | Experimental | 15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon |
|
| Cutting balloon | Experimental | 15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Predilatation with non-compliant balloon | Device | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petra Jiroušková, Mgr | Contact | +420466014182 | petra.jirouskova@kca.agel.cz |
| Name | Affiliation | Role |
|---|---|---|
| Ivo Varvařovský, MUDr, Ph.D | Cardiology Center AGEL a.s. | Principal Investigator |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Predilatation with scoring balloon (Scoroflex) | Device | 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) |
|
| Predilatation with cutting balloon (Flextome) | Device | 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) |
|
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 |
| D014652 |
| Vascular Diseases |