CompletedNCT01740895ADVISEIIUpdated Aug 6, 2014

ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II

An observational study in Cardiovascular Disease, sponsored by Volcano Corporation. Completed at 44 sites in 8 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-08-06.

Sponsored by Volcano Corporation · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 818
Ages: 18 Years to 85 Years
Sex: All

Study 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)

Conditions studied

Cardiovascular Disease

Browse trials for

Cardiovascular Diseases 4,904

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 818 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Volcano Corporation is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patient receiving a standard of care FFR measurment in the cath lab setting.

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

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
Enrollment: 818 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

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.
Time frame: at the time of study procedure- 1 day

Secondary outcomes

Specificity
Minimum iFR exclusion ranges around iFR 0.89 in which iFR and FFR agreement is equal to or greater than 80% and 90%
Time frame: at the time of study procedure- 1 day

Other outcomes

Sensitivity
Minimum iFR exclusion ranges around iFR 0.89 in which iFR and FFR agreement is equal to or greater than 80% and 90%
Time frame: at the time of study procedure- 1 day

Study locations

44 sites

Chandler Regional Medical Center
Chandler, Arizona 85224, United States
Mercy Gilbert Medical Center
Gilbert, Arizona 85297, United States
Coloado Heart and Vascular/St Anthony's
Lakewood, Colorado 80228, United States
Cardiovascular Research of Florida
Gainesville, Florida 32605, United States
North Florida regional Medical center
Gainsville, Florida 32605, United States
Baptist Cardiac & Vascular Institute
Miami, Florida 33176, United States
Winter Haven Hospital
Winter Haven, Florida 33881, United States
St Johns Hospital/ Prairie Education and Research
Springfield, Illinois 62701, United States
University of Minnesota
Minneapolis, Minnesota 55455, United States
St. Marys Hospital/ MAYO Clinic
Rochester, Minnesota 55902, United States
Regions Hospital Heart Center
St Paul, Minnesota 55101, United States
Washington University
St Louis, Missouri 63110, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey 08240, United States
Stony Brook Medicine
Stony Brook, New York 11794, United States
University of North Carolina Hospital
Chapel Hill, North Carolina 27599, United States
Duke University Hospital
Durham, North Carolina 27705, United States
East Carolina University/ Pitt County Hospital
Greenville, North Carolina 27835, United States
Wake Heart research/ Rex Hospital
Raleigh, North Carolina 27607, United States
Wake Heart research/ Wake Medical Center
Raleigh, North Carolina 27610, United States
Forsyth Medical Center
Winston-Salem, North Carolina 27103, United States
Geisinger Medical Center
Danville, Pennsylvania 17822, United States
UPMC Hamot
Erie, Pennsylvania 16550, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212, United States
Allegheny General
Pittsburgh, Pennsylvania 15212, United States
Medical University of South Carolina
Charleston, South Carolina 29425, United States
VA Charleston (RALPH H. JOHNSON VA MEDICAL CENTER)
Charleston, South Carolina 29425, United States
Greenville Memorial Hospital
Greenville, South Carolina 29605, United States
Wellmont Holston Valley Medical center
Kingsport, Tennessee 37660, United States
Sentara Health/Norfolk General Hospital
Norfolk, Virginia 23507, United States
Auora St Lukes
Milwaukee, Wisconsin 53233, United States
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada
Al Dorrah
Cairo, Egypt
Kerckhoff Klinik Bad Nauheim
Bad Nauheim, Germany
AMC Amsterdam
Amsterdam, Netherlands
Breda Amphia Ziekenhuis
Breda, Netherlands
Medische Spectrum Twente
Enschede, Netherlands
ERASMUS MC Rotterdam
Rotterdam, Netherlands
Jagiellonian University, Institute of Cardiology
Krakow, Poland
MSWiA Warszawa Woloska
Warsaw, Poland
Polikliniką SP ZOZ we Wrocławiu
Wroclaw, Poland
Hospital Universitario San Juan
Alicante, Spain
Hospital Universitario La Paz de Madrid
Madrid, Spain
Hospital Cl¡nico San Carlos
Marid, Spain
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom

References and documents

Publications

Echavarria-Pinto M, van de Hoef TP, Garcia-Garcia HM, de Vries T, Serruys PW, Samady H, Piek JJ, Lerman A, Escaned J; ADVISE II Study Group. Diagnostic Accuracy of Baseline Distal-to-Aortic Pressure Ratio to Assess Coronary Stenosis Severity: A Post-Hoc Analysis of the ADVISE II Study. JACC Cardiovasc Interv. 2015 May;8(6):834-836. doi: 10.1016/j.jcin.2014.12.245. No abstract available. PubMed 25999107 ↗
Escaned J, Echavarria-Pinto M, Garcia-Garcia HM, van de Hoef TP, de Vries T, Kaul P, Raveendran G, Altman JD, Kurz HI, Brechtken J, Tulli M, Von Birgelen C, Schneider JE, Khashaba AA, Jeremias A, Baucum J, Moreno R, Meuwissen M, Mishkel G, van Geuns RJ, Levite H, Lopez-Palop R, Mayhew M, Serruys PW, Samady H, Piek JJ, Lerman A; ADVISE II Study Group. Prospective Assessment of the Diagnostic Accuracy of Instantaneous Wave-Free Ratio to Assess Coronary Stenosis Relevance: Results of ADVISE II International, Multicenter Study (ADenosine Vasodilator Independent Stenosis Evaluation II). JACC Cardiovasc Interv. 2015 May;8(6):824-833. doi: 10.1016/j.jcin.2015.01.029. PubMed 25999106 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01740895
Lead sponsor: Volcano Corporation
Responsible party: Sponsor
First posted: Dec 4, 2012
Start date: Dec 2012
Primary completion: Jun 2013
Completion: Jun 2013
Last update: Aug 6, 2014

Study contacts

Javier Escaned, MD

principal investigator · Hospital Cl¡nico San Carlos Madrid Spain

Amir Lerman, MD

principal investigator · Mayo Clinic Rochester MN USA

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cardiovascular Diseases→

Other studies from this sponsor

Volcano Corporation

Start the discussion