Optimal Predilatation Technique for BVS Implantation (OPTI-BVS)

October 25, 2016 updated by: MUDr. Ivo Varvařovský, Ph.D, Cardiology Center Agel
The purpose of this study is to determine the optimal way of predilatation for BVS implantation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non-compliant balloon
15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon
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)
Experimental: Scoring balloon
15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon
Device: 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)
Experimental: Cutting balloon
15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon
Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal lumen area (MLA) in the BVS (mm2)
Time Frame: Immediately after BVS implantation
After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area.
Immediately after BVS implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically - driven target vessel revascularization
Time Frame: 12 months after the procedure
Patient is followed after BVS implantation in 1,6 and 12 months in the outpatient department.
12 months after the procedure
Eccentricity index
Time Frame: 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.
Immediately after BVS implantation
Expansion index
Time Frame: 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.
Immediately after BVS implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiology Center Agel

Investigators

  • Principal Investigator: Ivo Varvařovský, MUDr, Ph.D, Cardiology Center AGEL a.s.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

October 21, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 27, 2016

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG4201601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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