Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
45 participants
INTERVENTIONAL
2016-11-30
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non-compliant balloon
15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon
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)
Scoring balloon
15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon
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)
Cutting balloon
15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Cardiology Center Agel
OTHER
Responsible Party
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MUDr. Ivo Varvařovský, Ph.D
Head of Cardiology Center Agel
Principal Investigators
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Ivo Varvařovský, MUDr, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Cardiology Center AGEL a.s.
Central Contacts
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Other Identifiers
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RG4201601
Identifier Type: -
Identifier Source: org_study_id