Coronary Artery StenosisPhase 3OPTI-BVSNCT02946320
Optimal Predilatation Technique for BVS Implantation
A Phase 3 study testing Predilatation with non-compliant balloon, Predilatation with scoring balloon (Scoroflex) and Predilatation with cutting balloon (Flextome) in people with Coronary Artery Stenosis, run by Cardiology Center Agel.
Trial summary
The purpose of this study is to determine the optimal way of predilatation for BVS implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Stenosis
- What is being tested?
- Predilatation with non-compliant balloon, Predilatation with scoring balloon (Scoroflex) and Predilatation with cutting balloon (Flextome)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to determine the optimal way of predilatation for BVS implantation.
Read the 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).
- Conditions
- Coronary Artery Stenosis
- Being tested
- Predilatation with non-compliant balloon, Predilatation with scoring balloon (Scoroflex), Predilatation with cutting balloon (Flextome)
- Keywords
- PCI, bioabsorbable scaffold
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predilatation with non-compliant balloonDevice
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)Device
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)Device
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)
| Study group | Role | What they receive |
|---|---|---|
| Non-compliant balloon | Active comparator | 15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon Receives: Device: Predilatation with non-compliant balloon |
| Scoring balloon | Experimental | 15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon Receives: Device: Predilatation with scoring balloon (Scoroflex) |
| Cutting balloon | Experimental | 15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon Receives: Device: Predilatation with cutting balloon (Flextome) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal lumen area (MLA) in the BVS (mm2)
After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area.
Measured: Immediately after BVS implantation
Secondary outcomes (3)
Clinically - driven target vessel revascularization
Patient is followed after BVS implantation in 1,6 and 12 months in the outpatient department.
Measured: 12 months after the procedure
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.
Measured: Immediately after BVS implantation
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.
Measured: Immediately after BVS implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiology Center Agel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUDr. Ivo Varvařovský, Ph.D, Cardiology Center Agel
- Investigators
- Ivo Varvařovský, MUDr, Ph.D, Principal investigator, Cardiology Center AGEL a.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946320
- Sponsor's protocol ID
- RG4201601
- Acronym
- OPTI-BVS
- Status last verified
- Oct 2016
- First submitted
- 21 Oct 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Predilatation Technique for BVS Implantation
- ClinicalTrials.gov ID
- NCT02946320
- Acronym / sponsor ID
- OPTI-BVS / RG4201601
- Conditions
- Coronary Artery Stenosis
- Keywords
- PCI, bioabsorbable scaffold
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cardiology Center AgelUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the optimal way of predilatation for BVS implantation.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-compliant balloon | Active comparator | Device: Predilatation with non-compliant balloon15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon |
| Scoring balloon | Experimental | Device: Predilatation with scoring balloon (Scoroflex)15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon |
| Cutting balloon | Experimental | Device: Predilatation with cutting balloon (Flextome)15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predilatation with non-compliant balloonCoronary 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 | Non-compliant 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) | Device | Scoring 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) | Device | Cutting balloon |
Primary outcome
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.
3 secondary outcomes
Clinically - driven target vessel revascularization
Time frame: 12 months after the procedure
Eccentricity index
Time frame: Immediately after BVS implantation
Expansion index
Time frame: Immediately after BVS implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Individual participant dataSharing planned: Yes
Related trials for Coronary Artery Stenosis
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
MCG Algorithm Optimization Study in Patients With Coronary Artery Stenosis
Coronary Artery Disease
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Not yet recruiting
Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation
Coronary Artery Disease, Coronary Stent Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivo Varvařovský, MUDr, Ph.D principal investigator
Cardiology Center AGEL a.s.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Predilatation with non-compliant balloon, Predilatation with scoring balloon (Scoroflex) and Predilatation with cutting balloon (Flextome) in people with Coronary Artery Stenosis, run by Cardiology Center Agel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petra Jiroušková, Mgr (+420466014182, petra.jirouskova@kca.agel.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal lumen area (MLA) in the BVS (mm2) (time frame: Immediately after BVS implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.