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
	
									4500 South Lancaster Road
Dallas, Texas 75216
	
			
					Dallas, Texas 75216
Principal Investigator: Subash Banerjee, MD
			
						
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									1364 Clifton Rd NE
Atlanta, Georgia 30322
	
			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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								Davenport, Iowa 52803			
	
			
					Principal Investigator: Nick Shammas
			
						
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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
							 
					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
							 
					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
							 
					Principal Investigator: Amir Lofti, MD
			
						
								
		Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...  
  
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