Clinical trial NCT03084367: Physiologic Assessment of Coronary Stenosis Following PCI
Official title: DEFINE PCI: Physiologic Assessment of Coronary Stenosis Following PCI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Coronary Stenosis
Angina, Unstable
Angina, Stable
Lead sponsor: Volcano Corporation
Sponsor class: INDUSTRY
Collaborators: name: Duke Clinical Research Institute
name: Cardiovascular Research Foundation, New York
First posted: 2017-03-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consented subjects with CAD who undergo physiologic lesion assessment with iFR\<0.90 in at least 1 coronary artery are eligible for participation

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Residual Ischemia (iFR <0.90)
timeFrame: end of procedure/intervention
Secondary outcomes:
measure: Cardiac Events
timeFrame: 12 months
measure: Target Vessel Failure
timeFrame: 12 months
measure: Quality of Life Change From Baseline to 12 Months Follow-up
timeFrame: 12 months
measure: Cardiac Mortality
timeFrame: 12 months
measure: Target Vessel MI
timeFrame: 12 month
measure: Target Vessel Revascularization
timeFrame: 12 month
measure: Recurrent Ischemia
timeFrame: 12 month
measure: Correlation Between iFR and Angiographic Visual Interpretation
timeFrame: at the end of the procedure/intervention
measure: Number of Participants in Which the iFR Would Become Non-significant if a Focal Stenosis Demonstrated by iFR Pullback Were Treated With PCI
timeFrame: Procedural
measure: Differentiation
timeFrame: End of procedure /intervention
measure: Delta iFR
timeFrame: at the end of the procedure/intervention
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Medical Center
state: California
city: Lakewood
country: United States
facility: Colorado Heart and Vascular
state: Colorado
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Rockford
country: United States
facility: Rockford CV Associates
state: Illinois
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth Hitchcock
state: New Hampshire
city: Bay Shore
country: United States
facility: South Side Hospital
state: New York
city: Manhasset
country: United States
facility: Northshore Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/NewYork Presbyterian Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital -Weill Cornell
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Roslyn
country: United States
facility: St Francis Hospital
state: New York
city: Stony Brook
country: United States
facility: SUNY- Stony Brook
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: Kingsport
country: United States
facility: Wellmont CVA Heart Insitute
state: Tennessee
city: Dallas
country: United States
facility: VA North Texas Health Care
state: Texas
city: Milwaukee
country: United States
facility: Aurora St Lukes Medical Center
state: Wisconsin
city: Amsterdam
country: Netherlands
facility: AMC Amsterdam
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Basildon
country: United Kingdom
facility: Basildon Univeristy Hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth hospital
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College of London- Hammersmith Hospital
Study officials:
affiliation: Philips (Volcano)
name: Becky Inderbitzen, MSE
role: STUDY_DIRECTOR
References:
citation: Jeremias A, Davies JE, Maehara A, Matsumura M, Schneider J, Tang K, Talwar S, Marques K, Shammas NW, Gruberg L, Seto A, Samady H, Sharp A, Ali ZA, Mintz G, Patel M, Stone GW. Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):1991-2001. doi: 10.1016/j.jcin.2019.05.054.
citation: Patel MR, Jeremias A, Maehara A, Matsumura M, Zhang Z, Schneider J, Tang K, Talwar S, Marques K, Shammas NW, Gruberg L, Seto A, Samady H, Sharp ASP, Ali ZA, Mintz G, Davies J, Stone GW. 1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI: DEFINE PCI Trial. JACC Cardiovasc Interv. 2022 Jan 10;15(1):52-61. doi: 10.1016/j.jcin.2021.09.042.