Optimal Predilatation Technique for BVS Implantation
OPTI-BVS
1 other identifier
interventional
45
0 countries
N/A
Brief Summary
The purpose of this study is to determine the optimal way of predilatation for BVS implantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2016
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2016
CompletedFirst Posted
Study publicly available on registry
October 27, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedOctober 27, 2016
October 1, 2016
4 months
October 21, 2016
October 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Clinically - driven target vessel revascularization
12 months after the procedure
Eccentricity index
Immediately after BVS implantation
Expansion index
Immediately after BVS implantation
Study Arms (3)
Non-compliant balloon
ACTIVE COMPARATOR15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon
Scoring balloon
EXPERIMENTAL15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon
Cutting balloon
EXPERIMENTAL15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon
Interventions
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)
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)
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
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ivo Varvařovský, MUDr, Ph.D
Cardiology Center AGEL a.s.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Cardiology Center Agel
Study Record Dates
First Submitted
October 21, 2016
First Posted
October 27, 2016
Study Start
November 1, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
October 27, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share