Coronary Bifurcation LesionsNCT03027830
iFR Pressure Wires in Assessment of the Provisional Side-branch Intervention Strategy for Bifurcation Lesions
A study testing iFR pressure-wire and Conventional in people with Coronary Bifurcation Lesions, run by Nova-Med Medical Research Association.
Trial summary
Even in the era of drug-eluting stents, bifurcation lesions remain one of the most challenging lesion subsets in coronary intervention practice. This study was performed to evaluate the functional outcomes of pressure wires (IFR)-guided jailed side-branch intervention strategy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Bifurcation Lesions
- What is being tested?
- iFR pressure-wire and Conventional
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jan 2017
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with acute coronary syndrome
- Jailed side-branch of a vessel size > 2 mm
- Vessel length > 40 mm
- Lesion length < 10 mm by visual estimation
Who cannot join
- Significant stenosis in the left main coronary artery or the main branch proximal to the stented segment
- Totally occluded bifurcation lesions
- Primary myocardial disease
- Serum creatinine level of ≥ 2.
About this study
Official title: Physiological and Clinical Assessment of the Provisional Side-branch Intervention Strategy for Coronary Bifurcation Lesions Using iFR Pressure Wires
Even in the era of drug-eluting stents, bifurcation lesions remain one of the most challenging lesion subsets in coronary intervention practice. This study was performed to evaluate the functional outcomes of pressure wires (IFR)-guided jailed side-branch intervention strategy.
Read the detailed description
Fractional flow reserve (FFR) measurements require minimal and constant microvascular resistance which is routinely achieved by intravenous adenosine infusion. Adenosine-induced hyperemia establishes an optimal vascular environment for FFR measurement. However, breathlessness and chest tightness are common adverse events during adenosine infusion and severe asthma occurs occasionally. The Introduction of an adenosine-independent index (instantaneous wave-free ratio [iFR]) into clinical practice offered easier and hyperemia-free method for lesion assessment.
Physiological changes and clinical evaluation of iFR warrants further research. Therefore, the investigators conducted this study to evaluate the functional aspects of iFR-guided provisional jailed side-branch intervention strategy and compare clinical endpoints to conventional non-iFR-guided operations.
- Conditions
- Coronary Bifurcation Lesions
- Being tested
- iFR pressure-wire, Conventional
- Keywords
- Provisional side-branch intervention strategy, iFR, Pilot study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFR pressure-wireDevice
The instantaneous wave-free ratio (iFR) as an adenosine-independent index of coronary stenosis severity, calculated as the ratio between the distal trans-stenotic pressure and the proximal coronary pressure during a specific diastolic wave-free period
ConventionalDevice
Other diagnostic devices (including FFR and angiography)
| Study group | Role | What they receive |
|---|---|---|
| iFR pressure-wire | Experimental | Not described Receives: Device: iFR pressure-wire |
| Conventional | Active comparator | Not described Receives: Device: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological evaluation of iFR-guided intervention
iFR changes after drug-eluting balloon (DEB) inflation of the jailed side branch.
Measured: 6-month
Secondary outcomes (8)
length of hospital stay
Measured: 6-month
Procedure time
Measured: 30-day
Fluoroscopy time
Measured: 30-day
In-hospital heart failure class
Measured: 30-day
6-month heart failure class
Measured: 6-month
Post-PCI angina
Comparison of the incidence of angina after performing PCI in both the iFR and conventional groups
Measured: 6-month
Ejection fraction at 6 months' post operation
Measured: 6-month
The amount of dye injection for angiography
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startMar 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Bifurcation LesionsStudies 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova-Med Medical Research Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027830
- Sponsor's protocol ID
- 1
- Status last verified
- Jan 2017
- First submitted
- 18 Jan 2017
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Clinical Assessment of the Provisional Side-branch Intervention Strategy for Coronary Bifurcation Lesions Using iFR Pressure Wires
- ClinicalTrials.gov ID
- NCT03027830
- Acronym / sponsor ID
- 1
- Conditions
- Coronary Bifurcation Lesions
- Keywords
- Provisional side-branch intervention strategy, iFR, Pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nova-Med Medical Research AssociationUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 Jan 2017 (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.
Even in the era of drug-eluting stents, bifurcation lesions remain one of the most challenging lesion subsets in coronary intervention practice. This study was performed to evaluate the functional outcomes of pressure wires (IFR)-guided jailed side-branch intervention strategy.
Detailed description
Fractional flow reserve (FFR) measurements require minimal and constant microvascular resistance which is routinely achieved by intravenous adenosine infusion. Adenosine-induced hyperemia establishes an optimal vascular environment for FFR measurement. However, breathlessness and chest tightness are common adverse events during adenosine infusion and severe asthma occurs occasionally. The Introduction of an adenosine-independent index (instantaneous wave-free ratio [iFR]) into clinical practice offered easier and hyperemia-free method for lesion assessment.
Physiological changes and clinical evaluation of iFR warrants further research. Therefore, the investigators conducted this study to evaluate the functional aspects of iFR-guided provisional jailed side-branch intervention strategy and compare clinical endpoints to conventional non-iFR-guided operations.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iFR pressure-wire | Experimental | Device: iFR pressure-wire |
| Conventional | Active comparator | Device: Conventional |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with acute coronary syndrome
- Jailed side-branch of a vessel size > 2 mm
- Vessel length > 40 mm
- Lesion length < 10 mm by visual estimation
Key exclusion criteria (4 listed)
- Significant stenosis in the left main coronary artery or the main branch proximal to the stented segment
- Totally occluded bifurcation lesions
- Primary myocardial disease
- Serum creatinine level of ≥ 2.
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 |
|---|---|---|
| iFR pressure-wireThe instantaneous wave-free ratio (iFR) as an adenosine-independent index of coronary stenosis severity, calculated as the ratio between the distal trans-stenotic pressure and the proximal coronary pressure during a specific diastolic wave-free period | Device | iFR pressure-wire |
| ConventionalOther diagnostic devices (including FFR and angiography) | Device | Conventional |
Primary outcome
Physiological evaluation of iFR-guided intervention
Time frame: 6-month
iFR changes after drug-eluting balloon (DEB) inflation of the jailed side branch.
8 secondary outcomes
length of hospital stay
Time frame: 6-month
Procedure time
Time frame: 30-day
Fluoroscopy time
Time frame: 30-day
In-hospital heart failure class
Time frame: 30-day
6-month heart failure class
Time frame: 6-month
Post-PCI angina
Time frame: 6-month
Ejection fraction at 6 months' post operation
Time frame: 6-month
The amount of dye injection for angiography
Time frame: 30-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing iFR pressure-wire and Conventional in people with Coronary Bifurcation Lesions, run by Nova-Med Medical Research Association.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 23 Jan 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological evaluation of iFR-guided intervention (time frame: 6-month). 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 23 Jan 2017.