Physiologic Assessment of Coronary Stenosis Following PCI

Completed

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

In brief

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).

Key facts

Study ID

NCT03084367

Run by

Volcano Corporation

People needed

500

Starts

2017-06-20

Expected to finish

2020-02-18

Last updated by the study team

2022-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• VA Medical Center — Long Beach, California, United States
• Colorado Heart and Vascular — Lakewood, Colorado, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Atlanta VA Medical Center — Decatur, Georgia, United States
• Rockford CV Associates — Rockford, Illinois, United States
• Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Dartmouth Hitchcock — Lebanon, New Hampshire, United States
• South Side Hospital — Bay Shore, New York, United States
• Northshore Hospital — Manhasset, New York, United States
• Columbia University Medical Center/NewYork Presbyterian Hospital — New York, New York, United States
• New York Presbyterian Hospital -Weill Cornell — New York, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• St Francis Hospital — Roslyn, New York, United States
• SUNY- Stony Brook — Stony Brook, New York, United States
• Duke University Hospital — Durham, North Carolina, United States
• Vidant Medical Center — Greenville, North Carolina, United States
• Miriam Hospital — Providence, Rhode Island, United States
• Wellmont CVA Heart Insitute — Kingsport, Tennessee, United States
• VA North Texas Health Care — Dallas, Texas, United States
• Aurora St Lukes Medical Center — Milwaukee, Wisconsin, United States
• AMC Amsterdam — Amsterdam, Netherlands
• VU University Medical Center — Amsterdam, Netherlands
• Basildon Univeristy Hospital — Basildon, United Kingdom

Full record on ClinicalTrials.gov

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