iFR Pressure Wires in Assessment of the Provisional Side-branch Intervention Strategy for Bifurcation Lesions

Coronary Bifurcation Lesions Clinical Trial

Official title:

Physiological and Clinical Assessment of the Provisional Side-branch Intervention Strategy for Coronary Bifurcation Lesions Using iFR Pressure Wires

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027830
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: January 18, 2017
• Last updated: January 20, 2017
• Start date: March 2014
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Nova-Med Medical Research Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Bifurcation Lesions

Intervention

Device:
• 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
• Conventional
Other diagnostic devices (including FFR and angiography)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nova-Med Medical Research Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological evaluation of iFR-guided intervention	iFR changes after drug-eluting balloon (DEB) inflation of the jailed side branch.	6-month
Secondary	length of hospital stay		6-month
Secondary	Procedure time		30-day
Secondary	Fluoroscopy time		30-day
Secondary	In-hospital heart failure class		30-day
Secondary	6-month heart failure class		6-month
Secondary	Post-PCI angina	Comparison of the incidence of angina after performing PCI in both the iFR and conventional groups	6-month
Secondary	Ejection fraction at 6 months' post operation		6-month
Secondary	The amount of dye injection for angiography		30-day