ADenosine Vasodilator Independent Stenosis Evaluation II... | NCT01740895

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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%

Name	Affiliation	Role
Javier Escaned, MD	Hospital Cl¡nico San Carlos Madrid Spain	Principal Investigator
Amir Lerman, MD	Mayo Clinic Rochester MN USA	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Chandler Regional Medical Center		Chandler	Arizona	85224	United States
Mercy Gilbert Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25999107	Derived	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.
25999106