Optimal Predilatation Technique for BVS Implantation (OPTI-BVS)

Cardiology Center Agel

Status and phase: Unknown; Phase 3

Conditions: Coronary Artery Stenosis

Treatments: Device: Predilatation with cutting balloon (Flextome); Device: Predilatation with scoring balloon (Scoroflex); Device: Predilatation with non-compliant balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02946320

RG4201601

Details and patient eligibility

About

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

Full 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).

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Non-compliant balloon

Active Comparator group

Description:

15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon

Treatment:

Device: Predilatation with non-compliant balloon

Scoring balloon

Experimental group

Description:

15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon

Treatment:

Device: Predilatation with scoring balloon (Scoroflex)

Cutting balloon

Experimental group

Description:

15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon

Treatment:

Device: Predilatation with cutting balloon (Flextome)