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 |
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.
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
Davenport, Iowa 52803
Principal Investigator: Nick Shammas
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1364 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 712-2000
![Emory University Hospital](/wp-content/uploads/logos/emory-university-hospital.png)
Principal Investigator: Habib Samady
Emory University Hospital As the largest health care system in Georgia and the only health...
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4500 South Lancaster Road
Dallas, Texas 75216
Dallas, Texas 75216
Principal Investigator: Subash Banerjee, MD
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2050 Meadowview Parkway
Kingsport, Tennessee 37660
Kingsport, Tennessee 37660
Principal Investigator: Mark Mayhew, MD
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
414-649-6000
![Aurora St. Luke's Medical Center](/wp-content/uploads/logos/aurora-st-luke-s-medical-center.jpg)
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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Minneapolis, Minnesota 55407
Principal Investigator: Emmanouil Brilakis, MD
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New York, New York 10021
Principal Investigator: Chiu Wong, MD
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New York, New York 10032
Principal Investigator: Ajay Kirtane, MD
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164 Summit Ave
Providence, Rhode Island 02906
Providence, Rhode Island 02906
(401) 793-2500
![Miriam Hospital](/wp-content/uploads/logos/miriam-hospital.png)
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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759 Chestnut Street
Springfield, Massachusetts 01199
Springfield, Massachusetts 01199
(413) 794 - 0000
![Baystate Medical Center](/wp-content/uploads/logos/baystate-medical-center.jpg)
Principal Investigator: Amir Lofti, MD
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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