Physiologic Assessment of Coronary Stenosis Following PCI

Completed

Conditions: Angina, Unstable
Coronary Stenosis
Angina, Stable
Coronary Artery Disease

Interventions: Diagnostic Test: iFR pullback

Registration Number: NCT03084367

Lead Sponsor: Volcano Corporation

Brief Summary: This is a pilot study designed to assess the relationship between iFR (instantaneous wave-free ratio) pullback and the distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography (QCA) post angiographically successful PCI (Percutaneous Coronary Intervention).

Detailed Description: DEFINE-PCI is a multi-center, prospective, non-significant risk study in up to 25 centers in USA and internationally. Consented subjects with CAD (Coronary Artery Disease) who undergo physiologic lesion assessment with iFR\<0.90 in at least 1 coronary artery are eligible for participation. After successful PCI to all culprit lesions based on angiographic assessment of the treating physician, a blinded post-PCI iFR and iFR pullback will be performed. The proportion of patients with impaired post-PCI iFR will be assessed, and the number of patients in whom ischemia could theoretically be normalized with further PCI determined. Additionally, the association between the post-PCI iFR results and cardiovascular events and clinical symptoms will be assessed. Follow-up will be at 1, 6 and 12 months, including administration of quality of life questionnaires.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 500

Inclusion Criteria

Subject must be > 18 years old
Subjects presenting with stable angina, silent ischemia or non-ST-elevation ACS (acute coronary syndrome) (unstable angina or biomarker positive)
Single vessel CAD with at least 2 separate lesions (≥10 mm apart) of ≥40% stenosis or a single long lesion of ≥20mm OR multi-vessel CAD, defined as at least 2 vessels with ≥40% stenosis
Pre-PCI iFR performed in all vessels intended for PCI
Pre-PCI iFR of <0.90 of at least 1 stenosis
Subjects are able and willing to comply with scheduled visits and tests and to provide informed consent.

Exclusion Criteria

Pregnant or planning to become pregnant for the duration of the study
Acute STEMI (ST-elevated Myocardial Infarction) within the past 7 days
Cardiogenic shock (sustained (>10 min) systolic blood pressure < 90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump).
Ionotropic or temporary pacing requirement
Sustained ventricular arrhythmias
Prior CABG (Coronary Artery Bypass Graft)
Known ejection fraction ≤30%
Chronic Total Occlusion (CTO)
Known severe mitral or aortic stenosis.
Any known medical comorbidity resulting in life expectancy < 12 months.
Participation in any investigational study that has not yet reached its primary endpoint.
Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).
TIMI flow <3 at baseline
Intra-coronary thrombus on baseline angiography

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
iFR post angiographically successful PCI	iFR pullback	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Residual Ischemia (iFR <0.90)	end of procedure/intervention	Residual ischemia is defined as iFR measurement \<0.90 after operator-assessed angiographically successful PCI (residual diameter stenosis \<50% in any treated lesion in the target vessel) This outcome describes the number of participants that had a residual ischemia (defined as iFR\<0.90) after a PCI that appeared to be successful based on angiography.

Secondary Outcome Measures

Name	Time	Method
Recurrent Ischemia	12 month	Recurrent ischemia at one-year
Target Vessel Revascularization	12 month	Ischemia-driven target vessel revascularization at one year
Differentiation	End of procedure /intervention	Differentiation of the cause for impaired iFR
Delta iFR	at the end of the procedure/intervention	Predictors of delta iFR before and after PCI, or predictors of impaired iFR Outcome is presented as the odds ratio (OR) that the post-PCI iFR will be \<0.90. An OR \> 1 means greater odds that the post-PCI iFR is \<0.90, OR = 1 means there is no association, and OR \< 1 means there is a lower odds that the post-PCI iFR is \<0.90.
Target Vessel MI	12 month	Target vessel Myocardial infarction at one year
Correlation Between iFR and Angiographic Visual Interpretation	at the end of the procedure/intervention	Correlation between iFR \<0.90 and coronary stenosis \>50% assessed by visual interpretation. This was tested using generalized estimating equations for logistic regression to account for the correlation of observations from the same subject. An absolute value of exactly 1 implies that a linear equation describes the relationship between iFR and visual interpretation of the angiography. Outcome reports how well the iFR value and the visual interpretation are in agreement (for example, when iFR \<0.90 and coronary stenosis \>50% assessed by visual interpretation the correlation is 1).
Target Vessel Failure	12 months	Target vessel failure defined as cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization
Quality of Life Change From Baseline to 12 Months Follow-up	12 months	Quality of life (assessed by the Seattle Angina Questionnaire) at baseline, 30-days, 6 months and 1 year (12 months). Minimum score is 0 and maximum score is 100, with a high score representing a more positive quality of life score. Outcome is the change in score from baseline to 12 months follow-up.
Cardiac Mortality	12 months	All-cause and cardiac mortality at one year
Number of Participants in Which the iFR Would Become Non-significant if a Focal Stenosis Demonstrated by iFR Pullback Were Treated With PCI	Procedural	Number of participants in which the iFR would become non-significant if a focal stenosis demonstrated by iFR pullback were treated with PCI
Cardiac Events	12 months	Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization or recurrent ischemia at one year after PCI

Trial Locations

Locations (28): VA Medical Center
🇺🇸
Long Beach, California, United States
Vidant Medical Center
🇺🇸
Greenville, North Carolina, United States
Wellmont CVA Heart Insitute
🇺🇸
Kingsport, Tennessee, United States
VA North Texas Health Care
🇺🇸
Dallas, Texas, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Atlanta VA Medical Center
🇺🇸
Decatur, Georgia, United States
Northshore Hospital
🇺🇸
Manhasset, New York, United States
Minneapolis Heart Institute
🇺🇸
Minneapolis, Minnesota, United States
Colorado Heart and Vascular
🇺🇸
Lakewood, Colorado, United States
Rockford CV Associates
🇺🇸
Rockford, Illinois, United States
Midwest Cardiovascular Research Foundation
🇺🇸
Davenport, Iowa, United States
Baystate Medical Center
🇺🇸
Springfield, Massachusetts, United States
Dartmouth Hitchcock
🇺🇸
Lebanon, New Hampshire, United States
South Side Hospital
🇺🇸
Bay Shore, New York, United States
Columbia University Medical Center/NewYork Presbyterian Hospital
🇺🇸
New York, New York, United States
St Francis Hospital
🇺🇸
Roslyn, New York, United States
New York Presbyterian Hospital -Weill Cornell
🇺🇸
New York, New York, United States
SUNY- Stony Brook
🇺🇸
Stony Brook, New York, United States
Lenox Hill Hospital
🇺🇸
New York, New York, United States
Duke University Hospital
🇺🇸
Durham, North Carolina, United States
Miriam Hospital
🇺🇸
Providence, Rhode Island, United States
Basildon Univeristy Hospital
🇬🇧
Basildon, United Kingdom
Aurora St Lukes Medical Center
🇺🇸
Milwaukee, Wisconsin, United States
VU University Medical Center
🇳🇱
Amsterdam, Netherlands
AMC Amsterdam
🇳🇱
Amsterdam, Netherlands
Royal Bournemouth hospital
🇬🇧
Bournemouth, United Kingdom
Royal Devon & Exeter NHS Foundation Trust
🇬🇧
Exeter, United Kingdom
Imperial College of London- Hammersmith Hospital
🇬🇧
London, United Kingdom