Optimal Predilatation Technique for BVS Implantation

Coronary Artery Stenosis Clinical Trial

— OPTI-BVS  

Official title:

Optimal Predilatation Technique for BVS Implantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02946320
• Other study ID #: RG4201601
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 21, 2016
• Last updated: October 25, 2016
• Start date: November 2016
• Est. completion date: March 2017

Study information

• Verified date: October 2016
• Source: Cardiology Center Agel
• Contact: Petra Jiroušková, Mgr
• Phone: +420466014182
• Email: petra.jirouskova[@]kca.agel.cz
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

Device:
• Predilatation 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)
• Predilatation 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)
• Predilatation 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cardiology Center Agel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No