ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II

NCT01740895 | Completed

• 1 other identifier: PFC-001
• Study Type: observational
• Target: 818
• Locations: 8 countries
• Sites: 44

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)

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Specificity

  at the time of study procedure- 1 day

Other Outcomes (1)

• Sensitivity

  at the time of study procedure- 1 day

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- 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)

You may not qualify if:

• \- 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%

Sponsors & Collaborators

• Volcano Corporation: lead

Study Sites (44)

Chandler Regional Medical Center

Chandler, Arizona, 85224, United States

Location

Mercy Gilbert Medical Center

Gilbert, Arizona, 85297, United States

Location

Coloado Heart and Vascular/St Anthony's

Lakewood, Colorado, 80228, United States

Location

Cardiovascular Research of Florida

Gainesville, Florida, 32605, United States

Location

North Florida regional Medical center

Gainsville, Florida, 32605, United States

Location

Baptist Cardiac & Vascular Institute

Miami, Florida, 33176, United States

Location

Winter Haven Hospital

Winter Haven, Florida, 33881, United States

Location

St Johns Hospital/ Prairie Education and Research

Springfield, Illinois, 62701, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

St. Marys Hospital/ MAYO Clinic

Rochester, Minnesota, 55902, United States

Location

Regions Hospital Heart Center

Saint Paul, Minnesota, 55101, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

AtlantiCare Regional Medical Center

Pomona, New Jersey, 08240, United States

Location

Stony Brook Medicine

Stony Brook, New York, 11794, United States

Location

University of North Carolina Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

East Carolina University/ Pitt County Hospital

Greenville, North Carolina, 27835, United States

Location

Wake Heart research/ Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Wake Heart research/ Wake Medical Center

Raleigh, North Carolina, 27610, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

UPMC Hamot

Erie, Pennsylvania, 16550, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Allegheny General

Pittsburgh, Pennsylvania, 15212, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

VA Charleston (RALPH H. JOHNSON VA MEDICAL CENTER)

Charleston, South Carolina, 29425, United States

Location

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Wellmont Holston Valley Medical center

Kingsport, Tennessee, 37660, United States

Location

Sentara Health/Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Auora St Lukes

Milwaukee, Wisconsin, 53233, United States

Location

Victoria Heart Institute Foundation

Victoria, British Columbia, Canada

Location

Al Dorrah

Cairo, Egypt

Location

Kerckhoff Klinik Bad Nauheim

Bad Nauheim, Germany

Location

AMC Amsterdam

Amsterdam, Netherlands

Location

Breda Amphia Ziekenhuis

Breda, Netherlands

Location

Medische Spectrum Twente

Enschede, Netherlands

Location

ERASMUS MC Rotterdam

Rotterdam, Netherlands

Location

Jagiellonian University, Institute of Cardiology

Krakow, Poland

Location

MSWiA Warszawa Woloska

Warsaw, Poland

Location

Polikliniką SP ZOZ we Wrocławiu

Wroclaw, Poland

Location

Hospital Universitario San Juan

Alicante, Spain

Location

Hospital Universitario La Paz de Madrid

Madrid, Spain

Location

Hospital Cl¡nico San Carlos

Marid, Spain

Location

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 25999107 DERIVED

• 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.

  PMID: 25999106 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Javier Escaned, MD

  Hospital Cl¡nico San Carlos Madrid Spain

  PRINCIPAL INVESTIGATOR

• Amir Lerman, MD

  Mayo Clinic Rochester MN USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: December 4, 2012
• Study Start: December 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 6, 2014

Record last verified: 2014-08

Locations

US (30); GB (1); EG (1); DE (1); ES (3); CA (1); NL (4); PL (3)