ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II

Completed

• Conditions: Cardiovascular Disease

• Registration Number: NCT01740895
• Lead Sponsor: Volcano Corporation

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-29
• Study Start: 2012-12
• Study First Posted: 2012-12-04
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 818

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemodynamic Severity	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.

Secondary Outcome Measures

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

Trial Locations

Locations (44)

North Florida regional Medical center; 🇺🇸 Gainsville, Florida, United States

Coloado Heart and Vascular/St Anthony's; 🇺🇸 Lakewood, Colorado, United States

Chandler Regional Medical Center; 🇺🇸 Chandler, Arizona, United States

Mercy Gilbert Medical Center; 🇺🇸 Gilbert, Arizona, United States

Cardiovascular Research of Florida; 🇺🇸 Gainesville, Florida, United States

Winter Haven Hospital; 🇺🇸 Winter Haven, Florida, United States

St Johns Hospital/ Prairie Education and Research; 🇺🇸 Springfield, Illinois, United States

St. Marys Hospital/ MAYO Clinic; 🇺🇸 Rochester, Minnesota, United States

Regions Hospital Heart Center; 🇺🇸 St Paul, Minnesota, United States

Washington University; 🇺🇸 St Louis, Missouri, United States

Stony Brook Medicine; 🇺🇸 Stony Brook, New York, United States

AtlantiCare Regional Medical Center; 🇺🇸 Pomona, New Jersey, United States

University of North Carolina Hospital; 🇺🇸 Chapel Hill, North Carolina, United States

East Carolina University/ Pitt County Hospital; 🇺🇸 Greenville, North Carolina, United States

Wake Heart research/ Rex Hospital; 🇺🇸 Raleigh, North Carolina, United States

Wake Heart research/ Wake Medical Center; 🇺🇸 Raleigh, North Carolina, United States

Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

UPMC Hamot; 🇺🇸 Erie, Pennsylvania, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Allegheny General; 🇺🇸 Pittsburgh, Pennsylvania, United States

VA Charleston (RALPH H. JOHNSON VA MEDICAL CENTER); 🇺🇸 Charleston, South Carolina, United States

Greenville Memorial Hospital; 🇺🇸 Greenville, South Carolina, United States

Wellmont Holston Valley Medical center; 🇺🇸 Kingsport, Tennessee, United States

Auora St Lukes; 🇺🇸 Milwaukee, Wisconsin, United States

Sentara Health/Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States

Victoria Heart Institute Foundation; 🇨🇦 Victoria, British Columbia, Canada

Al Dorrah; 🇪🇬 Cairo, Egypt

Kerckhoff Klinik Bad Nauheim; 🇩🇪 Bad Nauheim, Germany

Breda Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

Medische Spectrum Twente; 🇳🇱 Enschede, Netherlands

Polikliniką SP ZOZ we Wrocławiu; 🇵🇱 Wroclaw, Poland

Jagiellonian University, Institute of Cardiology; 🇵🇱 Krakow, Poland

MSWiA Warszawa Woloska; 🇵🇱 Warsaw, Poland

Hospital Universitario San Juan; 🇪🇸 Alicante, Spain

Hospital Universitario La Paz de Madrid; 🇪🇸 Madrid, Spain

Hospital Cl¡nico San Carlos; 🇪🇸 Marid, Spain

AMC Amsterdam; 🇳🇱 Amsterdam, Netherlands

ERASMUS MC Rotterdam; 🇳🇱 Rotterdam, Netherlands

Baptist Cardiac & Vascular Institute; 🇺🇸 Miami, Florida, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

Liverpool Heart and Chest Hospital; 🇬🇧 Liverpool, United Kingdom