Physiologic Assessment of Coronary Stenosis Following PCI



Status:Recruiting
Conditions:Angina, Angina, Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:11/16/2018
Start Date:June 20, 2017
End Date:December 2019
Contact:TAMMY K SNOW
Email:tammy.snow@philips.com
Phone:336.466.0417

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DEFINE PCI: Physiologic Assessment of Coronary Stenosis Following PCI

This is a pilot study designed to assess the relationship between iFR pullback and the
distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography
(QCA) post angiographically successful PCI.


Inclusion Criteria:

1. Subject must be > 18 years old

2. Subjects presenting with stable angina, silent ischemia or non-ST-elevation ACS
(unstable angina or biomarker positive)

3. 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

4. Pre-PCI iFR performed in all vessels intended for PCI

5. Pre-PCI iFR of <0.90 of at least 1 stenosis

6. Subjects are able and willing to comply with scheduled visits and tests and to provide
informed consent.

Exclusion Criteria:

1. Pregnant or planning to become pregnant for the duration of the study

2. Acute STEMI within the past 7 days

3. Cardiogenic shock (sustained (>10 min) systolic blood pressure < 90 mmHg in absence of
inotropic support or the presence of an intra-aortic balloon pump).

4. Ionotropic or temporary pacing requirement

5. Sustained ventricular arrhythmias

6. Prior CABG

7. Known ejection fraction ≤30%

8. Chronic Total Occlusion (CTO)

9. Known severe mitral or aortic stenosis.

10. Any known medical comorbidity resulting in life expectancy < 12 months.

11. Participation in any investigational study that has not yet reached its primary
endpoint.

12. Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).

13. TIMI flow <3 at baseline

14. Intra-coronary thrombus on baseline angiography
We found this trial at
23
sites
Durham, North Carolina 27705
Principal Investigator: Manesh Patel, MD
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Durham, NC
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9 Meibergdreef
Amsterdam, 1105 AZ
Principal Investigator: Jan Piek, MD
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Amsterdam,
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Habib Samady
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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Bay Shore, New York 11706
Principal Investigator: Luis Gruberg
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from
Bay Shore, NY
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4500 South Lancaster Road
Dallas, Texas 75216
Principal Investigator: Subash Banerjee, MD
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Dallas, TX
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Davenport, Iowa 52803
Principal Investigator: Nick Shammas
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Davenport, IA
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Decatur, Georgia 30033
Principal Investigator: Gautam Kumar
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Decatur, GA
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Greenville, North Carolina 27834
Principal Investigator: Ashesh Buch, MD
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Greenville, NC
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2050 Meadowview Parkway
Kingsport, Tennessee 37660
Principal Investigator: Mark Mayhew, MD
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Kingsport, TN
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Lakewood, Colorado 80228
Principal Investigator: John Altman, MD
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Lakewood, CO
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Lebanon, New Hampshire 03756
Principal Investigator: John Jayne, MD
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Lebanon, NH
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Long Beach, California
Principal Investigator: Arnold Seto, MD
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Long Beach, CA
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Manhasset, New York 11030
Principal Investigator: LUIS GRUBERG
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Manhasset, NY
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Principal Investigator: Louie Kostopoulos, MD
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Milwaukee, WI
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Minneapolis, Minnesota 55407
Principal Investigator: Emmanouil Brilakis, MD
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Minneapolis, MN
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New York, New York 10021
Principal Investigator: Chiu Wong, MD
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New York, NY
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New York, New York 10032
Principal Investigator: Ajay Kirtane, MD
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from
New York, NY
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New York, New York 10021
Principal Investigator: LUIS GRUBERG
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from
New York, NY
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Principal Investigator: Paul Gordon, MD
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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Providence, RI
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Rockford, Illinois 61107
Principal Investigator: Robery Minor, MD
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Rockford, IL
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Roslyn, New York 11576
Principal Investigator: Richard Shlofmitz, MD
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Roslyn, NY
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759 Chestnut Street
Springfield, Massachusetts 01199
(413) 794 - 0000
Principal Investigator: Amir Lofti, MD
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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Springfield, MA
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Stony Brook, New York 11794
Principal Investigator: William Lawson, MD
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Stony Brook, NY
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