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)

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

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

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

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

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

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

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

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

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

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

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