Cardiovascular DiseaseADVISEIINCT01740895
ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II
An observational study of Cardiovascular Disease, run by Volcano Corporation at 44 sites in 8 countries.
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) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 818 participants
- Where
- 44 sitesin 8 countries
- Study dates
- Dec 2012to Jun 2013
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient receiving a standard of care FFR measurment in the cath lab setting.
Who may be able to join
- - 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)
Who cannot join
- - 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)
Show all 14Show fewer
- 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%
Trial locations and contacts
44 sites in 8 countries.
44 sites in 8 countries
United States30 sites
Chandler Regional Medical Center
Chandler, Arizona, 85224
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
VA Charleston (RALPH H. JOHNSON VA MEDICAL CENTER)
Charleston, South Carolina, 29425
Geisinger Medical Center
Danville, Pennsylvania, 17822
Duke University Hospital
Durham, North Carolina, 27705
UPMC Hamot
Erie, Pennsylvania, 16550
Cardiovascular Research of Florida
Gainesville, Florida, 32605
North Florida regional Medical center
Gainsville, Florida, 32605
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297
East Carolina University/ Pitt County Hospital
Greenville, North Carolina, 27835
Greenville Memorial Hospital
Greenville, South Carolina, 29605
Wellmont Holston Valley Medical center
Kingsport, Tennessee, 37660
Coloado Heart and Vascular/St Anthony's
Lakewood, Colorado, 80228
Baptist Cardiac & Vascular Institute
Miami, Florida, 33176
Auora St Lukes
Milwaukee, Wisconsin, 53233
University of Minnesota
Minneapolis, Minnesota, 55455
Sentara Health/Norfolk General Hospital
Norfolk, Virginia, 23507
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Allegheny General
Pittsburgh, Pennsylvania, 15212
AtlantiCare Regional Medical Center
Pomona, New Jersey, 08240
Wake Heart research/ Rex Hospital
Raleigh, North Carolina, 27607
Wake Heart research/ Wake Medical Center
Raleigh, North Carolina, 27610
St. Marys Hospital/ MAYO Clinic
Rochester, Minnesota, 55902
Regions Hospital Heart Center
Saint Paul, Minnesota, 55101
St Johns Hospital/ Prairie Education and Research
Springfield, Illinois, 62701
Washington University
St Louis, Missouri, 63110
Stony Brook Medicine
Stony Brook, New York, 11794
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Winter Haven Hospital
Winter Haven, Florida, 33881
Netherlands4 sites
AMC Amsterdam
Amsterdam
Breda Amphia Ziekenhuis
Breda
Medische Spectrum Twente
Enschede
ERASMUS MC Rotterdam
Rotterdam
Poland3 sites
Jagiellonian University, Institute of Cardiology
Krakow
MSWiA Warszawa Woloska
Warsaw
Polikliniką SP ZOZ we Wrocławiu
Wroclaw
Spain3 sites
Hospital Universitario San Juan
Alicante
Hospital Universitario La Paz de Madrid
Madrid
Hospital Cl¡nico San Carlos
Marid
About this study
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.
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
- Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the time of study procedure- 1 day
Secondary outcomes (1)
Specificity
Minimum iFR exclusion ranges around iFR 0.89 in which iFR and FFR agreement is equal to or greater than 80% and 90%
Measured: at the time of study procedure- 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 818 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volcano Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javier Escaned, MD, Principal investigator, Hospital Cl¡nico San Carlos Madrid SpainAmir Lerman, MD, Principal investigator, Mayo Clinic Rochester MN USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740895
- Sponsor's protocol ID
- PFC-001
- Acronym
- ADVISEII
- Status last verified
- Aug 2014
- First submitted
- 16 Nov 2012
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
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 25999107Escaned 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01740895
- Acronym / sponsor ID
- ADVISEII / PFC-001
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 818 participants (actual)
- Lead sponsor
- Volcano CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Dec 2012 (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.
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)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient receiving a standard of care FFR measurment in the cath lab setting.
Key inclusion criteria (5 listed)
- - 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)
Key exclusion criteria (14 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemodynamic Severity
Time frame: at the time of study procedure- 1 day
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.
1 secondary outcome
Specificity
Time frame: at the time of study procedure- 1 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 6 Aug 2014.
- Derived from this study: PubMed 25999107Echavarria-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.
- Derived from this study: PubMed 25999106Escaned 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.
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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.
Javier Escaned, MD principal investigator
Hospital Cl¡nico San Carlos Madrid Spain
Amir Lerman, MD principal investigator
Mayo Clinic Rochester MN USA
44 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Volcano Corporation at 44 sites in 8 countries.
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 5 inclusion and 14 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 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Netherlands, Poland, Spain, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Hemodynamic Severity (time frame: at the time of study procedure- 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01740895, which also lists 2 linked publications.
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 6 Aug 2014.