ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II

Cardiovascular Disease Clinical Trial

— ADVISEII  

Official title:

A Prospective, Observational, Non-randomized, Double Blind, Global, Multi-center Registry With an Adaptive Design, Investigating the Diagnostic Utility of Instantaneous Wave-free Ratio™ (iFR®) in Assessing Coronary Stenosis Relevance.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740895
• Other study ID #: PFC-001
• Status: Completed
• Phase: N/A
• First received: November 16, 2012
• Last updated: August 5, 2014
• Start date: December 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2014
• Source: Volcano Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

To assess the clinical value of iFR to characterize, without concomitant administration of hyperemic agents and outside a specified range of iFR values, coronary stenosis severity as determined with fractional flow reserve (FFR)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 818
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• - Patient must be > 18 and < 85 years of age

• Willing to participate and able to understand, read and sign the informed consent document before the planned procedure

• Eligible for coronary angiography and/or percutaneous coronary intervention

• Coronary artery disease with at least 1 or more visually assessed coronary stenoses (>40% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.

• Stable angina or acute coronary syndromes (non-culprit vessels only and outside of primary intervention during acute myocardial infarction)

Exclusion Criteria:

• - Known contraindication to adenosine administration

• Implanted temporary or permanent artificial pacemakers, Left Bundle Branch Block (LBBB), 1st and 2nd degree AV Block

• STEMI or non STEMI within 48 hours of procedure

• Any contraindications for FFR interrogation or percutaneous coronary intervention (PCI) as determined by the investigator

• Severe vessel tortuosity and/or severe calcification by angiogram

• Significant valvular pathology (moderate or severe AS/AR/MS/MR)

• Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel

• Weight >200kg (441 lbs.)

• Hemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg) balloon pump

• Significant hepatic disease, renal disease, lung disease (pulmonary chronic pulmonary obstructive disease) and/or malignant disease with unfavorable prognosis or presenting with abnormal serum laboratory values that the physician believes is clinically significant

• Contraindication to antithrombotic regimen or anticoagulation therapy

• History of or known reaction or sensitivity to contrast agent and is unable to be pre-medicated

• Left main stenosis, tandem stenosis separated by more than 5 mm that require separate pressure guide wire interrogation or PCI (not to be interrogated or treated as a single stenosis), or total occlusions

• Known Left ventricular ejection fraction (LVEF) <30%

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
Canada	Victoria Heart Institute Foundation	Victoria	British Columbia
Egypt	Al Dorrah	Cairo
Germany	Kerckhoff Klinik Bad Nauheim	Bad Nauheim
Netherlands	AMC Amsterdam	Amsterdam
Netherlands	Breda Amphia Ziekenhuis	Breda
Netherlands	Medische Spectrum Twente	Enschede
Netherlands	ERASMUS MC Rotterdam	Rotterdam
Poland	Jagiellonian University, Institute of Cardiology	Krakow
Poland	MSWiA Warszawa Woloska	Warsaw
Poland	Poliklinika SP ZOZ we Wroclawiu	Wroclaw
Spain	Hospital Universitario San Juan	Alicante
Spain	Hospital Universitario La Paz de Madrid	Madrid
Spain	Hospital Cl¡nico San Carlos	Marid
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool
United States	Chandler Regional Medical Center	Chandler	Arizona
United States	University of North Carolina Hospital	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	VA Charleston (RALPH H. JOHNSON VA MEDICAL CENTER)	Charleston	South Carolina
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Duke University Hospital	Durham	North Carolina
United States	UPMC Hamot	Erie	Pennsylvania
United States	Cardiovascular Research of Florida	Gainesville	Florida
United States	North Florida regional Medical center	Gainsville	Florida
United States	Mercy Gilbert Medical Center	Gilbert	Arizona
United States	East Carolina University/ Pitt County Hospital	Greenville	North Carolina
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	Wellmont Holston Valley Medical center	Kingsport	Tennessee
United States	Coloado Heart and Vascular/St Anthony's	Lakewood	Colorado
United States	Baptist Cardiac & Vascular Institute	Miami	Florida
United States	Auora St Lukes	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Sentara Health/Norfolk General Hospital	Norfolk	Virginia
United States	Allegheny General	Pittsburgh	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	AtlantiCare Regional Medical Center	Pomona	New Jersey
United States	Wake Heart research/ Rex Hospital	Raleigh	North Carolina
United States	Wake Heart research/ Wake Medical Center	Raleigh	North Carolina
United States	St. Marys Hospital/ MAYO Clinic	Rochester	Minnesota
United States	St Johns Hospital/ Prairie Education and Research	Springfield	Illinois
United States	Washington University	St Louis	Missouri
United States	Regions Hospital Heart Center	St Paul	Minnesota
United States	Stony Brook Medicine	Stony Brook	New York
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Winter Haven Hospital	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Volcano Corporation

Countries where clinical trial is conducted

United States,  Canada,  Egypt,  Germany,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sensitivity	Minimum iFR exclusion ranges around iFR 0.89 in which iFR and FFR agreement is equal to or greater than 80% and 90%	at the time of study procedure- 1 day	No
Primary	Hemodynamic Severity	Percentage of stenosis properly classified in terms of hemodynamic severity by iFR values =0.85 and =0.94. Hemodynamic severity will be established with an FFR value = 0.80.	at the time of study procedure- 1 day	No
Secondary	Specificity	Minimum iFR exclusion ranges around iFR 0.89 in which iFR and FFR agreement is equal to or greater than 80% and 90%	at the time of study procedure- 1 day	No