Physiologic Assessment of Coronary Stenosis Following PCI

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03084367
• Date of registration: 13/03/2017
• Prospective Registration: Yes
• Primary sponsor: Volcano Corporation
• Public title: Physiologic Assessment of Coronary Stenosis Following PCI DEFINE PCI
• Scientific title: DEFINE PCI: Physiologic Assessment of Coronary Stenosis Following PCI
• Date of first enrolment: June 20, 2017
• Target sample size: 500
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03084367
• Study type: Observational

Countries of recruitment

Netherlands, United Kingdom, United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Angina, Stable

Angina, Unstable

Coronary Stenosis

Coronary Artery Disease

Intervention(s)

Diagnostic Test: iFR pullback

Primary Outcome(s)

Rate of residual ischemia [Time Frame: 12 months]

Secondary Outcome(s)

Cardiac Mortality [Time Frame: 12 months]

Focal stenosis [Time Frame: 12 month]

Recurrent Ischemia [Time Frame: 12 month]

Cardiac Events [Time Frame: 12 months]

Correlation between iFR and angiographic visual interpretation [Time Frame: 12 month]

Quality of Life change [Time Frame: 12 months]

Target Vessel Failure [Time Frame: 12 months]

delta iFR [Time Frame: 12 months]

Target Vessel Revascularization [Time Frame: 12 month]

Differentiation [Time Frame: 12 months]

Target Vessel MI [Time Frame: 12 month]

Secondary ID(s)

160101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cardiovascular Research Foundation, New York

Duke Clinical Research Institute