Optimal Predilatation Technique for BVS Implantation

Phase 3

• Conditions: Coronary Artery Stenosis
• Interventions: Device: Predilatation with non-compliant balloon; Device: Predilatation with scoring balloon (Scoroflex); Device: Predilatation with cutting balloon (Flextome)

• Registration Number: NCT02946320
• Lead Sponsor: Cardiology Center Agel

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).

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-25
• Last Update Submitted: 2016-10-25
• Study First Posted: 2016-10-27
• Last Update Posted: 2016-10-27
• Study Start: 2016-11
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-compliant balloon	Predilatation with non-compliant balloon	15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon
Scoring balloon	Predilatation with scoring balloon (Scoroflex)	15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon
Cutting balloon	Predilatation with cutting balloon (Flextome)	15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.