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Optimal Predilatation Technique for BVS Implantation

NCT02946320 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-10-27

No results posted yet for this study

Summary

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

Conditions

  • Coronary Artery Stenosis

Interventions

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)

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)

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)

Sponsors & Collaborators

  • Cardiology Center Agel

    lead OTHER

Principal Investigators

  • Ivo Varvařovský, MUDr, Ph.D · Cardiology Center AGEL a.s.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-03-31
Completion
2017-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02946320 on ClinicalTrials.gov