Coronary Artery Stenosis
Conditions
Keywords
PCI, bioabsorbable scaffold
Brief summary
The purpose of this study is to determine the optimal way of predilatation for BVS implantation.
Detailed description
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).
Interventions
DEVICEPredilatation with non-compliant balloon
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)
DEVICEPredilatation with scoring balloon (Scoroflex)
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)
DEVICEPredilatation with cutting balloon (Flextome)
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)
Sponsors
Cardiology Center Agel
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
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimal lumen area (MLA) in the BVS (mm2) | Immediately after BVS implantation | After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically - driven target vessel revascularization | 12 months after the procedure | Patient is followed after BVS implantation in 1,6 and 12 months in the outpatient department. |
| Eccentricity index | Immediately after BVS implantation | 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. |
| Expansion index | Immediately after BVS implantation | 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. |
Contacts
Primary ContactPetra Jiroušková, Mgr
Outcome results
None listed