DEFINE PCI: Physiologic Assessment of Coronary Stenosis Following PCI

Status: Completed
Location: See all (28) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
VA Medical Center
Long Beach
Colorado
Colorado Heart and Vascular
Lakewood
Georgia
Emory University Hospital
Atlanta
Atlanta VA Medical Center
Decatur
Iowa
Midwest Cardiovascular Research Foundation
Davenport
Illinois
Rockford CV Associates
Rockford
Massachusetts
Baystate Medical Center
Springfield
Minnesota
Minneapolis Heart Institute
Minneapolis
North Carolina
Duke University Hospital
Durham
Vidant Medical Center
Greenville
New Hampshire
Dartmouth Hitchcock
Lebanon
New York
South Side Hospital
Bay Shore
Northshore Hospital
Manhasset
Columbia University Medical Center/NewYork Presbyterian Hospital
New York
Lenox Hill Hospital
New York
New York Presbyterian Hospital -Weill Cornell
New York
St Francis Hospital
Roslyn
SUNY- Stony Brook
Stony Brook
Rhode Island
Miriam Hospital
Providence
Tennessee
Wellmont CVA Heart Insitute
Kingsport
Texas
VA North Texas Health Care
Dallas
Wisconsin
Aurora St Lukes Medical Center
Milwaukee
Other Locations
Netherlands
AMC Amsterdam
Amsterdam
VU University Medical Center
Amsterdam
United Kingdom
Basildon Univeristy Hospital
Basildon
Royal Bournemouth hospital
Bournemouth
Royal Devon & Exeter NHS Foundation Trust
Exeter
Imperial College of London- Hammersmith Hospital
London
Time Frame
Start Date: 2017-06-20
Completion Date: 2020-02-18
Participants
Target number of participants: 500
Treatments
iFR post angiographically successful PCI
Sponsors
Leads: Volcano Corporation
Collaborators: Duke Clinical Research Institute, Cardiovascular Research Foundation, New York

This content was sourced from clinicaltrials.gov