- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03027830
iFR Pressure Wires in Assessment of the Provisional Side-branch Intervention Strategy for Bifurcation Lesions
Physiological and Clinical Assessment of the Provisional Side-branch Intervention Strategy for Coronary Bifurcation Lesions Using iFR Pressure Wires
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional
|
Other diagnostic devices (including FFR and angiography)
|
Experimental: iFR pressure-wire
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physiological evaluation of iFR-guided intervention
Time Frame: 6-month
|
iFR changes after drug-eluting balloon (DEB) inflation of the jailed side branch.
|
6-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
length of hospital stay
Time Frame: 6-month
|
6-month
|
|
Procedure time
Time Frame: 30-day
|
30-day
|
|
Fluoroscopy time
Time Frame: 30-day
|
30-day
|
|
In-hospital heart failure class
Time Frame: 30-day
|
30-day
|
|
6-month heart failure class
Time Frame: 6-month
|
6-month
|
|
Post-PCI angina
Time Frame: 6-month
|
Comparison of the incidence of angina after performing PCI in both the iFR and conventional groups
|
6-month
|
Ejection fraction at 6 months' post operation
Time Frame: 6-month
|
6-month
|
|
The amount of dye injection for angiography
Time Frame: 30-day
|
30-day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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