N/A
N=500
Physiologic Assessment of Coronary Stenosis Following PCI
Coronary Artery Disease · Coronary Stenosis · Angina, Unstable · Angina, Stable
Bottom Line
View on ClinicalTrials.gov: NCT03084367 ↗Enrolled (actual)
500
Serious AEs
2.6%
Results posted
May 2022
Primary outcome: Primary: Number of Participants With Residual Ischemia (iFR <0.90) — 112 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- iFR pullback (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Volcano Corporation
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Residual Ischemia (iFR <0.90) |
112 | — |
| SECONDARY Cardiac Events |
9; 3 | — |
| SECONDARY Target Vessel Failure |
4; 2 | — |
| SECONDARY Quality of Life Change From Baseline to 12 Months Follow-up |
21.42; 20.73 | — |
| SECONDARY Cardiac Mortality |
0; 0 | — |
| SECONDARY Target Vessel MI |
4; 2 | — |
| SECONDARY Target Vessel Revascularization |
10; 3 | — |
| SECONDARY Recurrent Ischemia |
6; 1 | — |
| SECONDARY Correlation Between iFR and Angiographic Visual Interpretation |
0.03 | — |
| SECONDARY Number of Participants in Which the iFR Would Become Non-significant if a Focal Stenosis Demonstrated by iFR Pullback Were Treated With PCI |
23 | — |
| SECONDARY Differentiation |
93; 21 | — |
| SECONDARY Delta iFR |
0.32; 5.65 | — |
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 Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT03084367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.