Physiologic Assessment of Coronary Stenosis Following PCI (DEFINE PCI)

Volcano

Status: Completed

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

Treatments: Diagnostic Test: iFR pullback

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03084367

160101

Details and patient eligibility

About

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).

Full description

DEFINE-PCI is a multi-center, prospective, non-significant risk study in up to 25 centers in USA and internationally. Consented subjects with CAD (Coronary Artery Disease) who undergo physiologic lesion assessment with iFR<0.90 in at least 1 coronary artery are eligible for participation. After successful PCI to all culprit lesions based on angiographic assessment of the treating physician, a blinded post-PCI iFR and iFR pullback will be performed. The proportion of patients with impaired post-PCI iFR will be assessed, and the number of patients in whom ischemia could theoretically be normalized with further PCI determined. Additionally, the association between the post-PCI iFR results and cardiovascular events and clinical symptoms will be assessed. Follow-up will be at 1, 6 and 12 months, including administration of quality of life questionnaires.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject must be > 18 years old
2. Subjects presenting with stable angina, silent ischemia or non-ST-elevation ACS (acute coronary syndrome) (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 (ST-elevated Myocardial Infarction) 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 (Coronary Artery Bypass Graft)
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

Trial design

500 participants in 1 patient group

iFR post angiographically successful PCI

Treatment:

Diagnostic Test: iFR pullback