Physiologic Assessment of Coronary Stenosis Following PCI

Coronary Artery Disease Clinical Trial

— DEFINE PCI  

Official title:

DEFINE PCI: Physiologic Assessment of Coronary Stenosis Following PCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084367
• Other study ID #: 160101
• Status: Completed
• Start date: June 20, 2017
• Est. completion date: February 18, 2020

Study information

• Verified date: February 2022
• Source: Volcano Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 18, 2020
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Stenosis

Intervention

Diagnostic Test:
• iFR pullback
iFR pullback assessment post angiographically successful PCI

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Volcano Corporation	Cardiovascular Research Foundation, New York, Duke Clinical Research Institute

Countries where clinical trial is conducted

United States,  Netherlands,  United Kingdom, 

References & Publications (1)

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 Angiograp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Residual Ischemia (iFR <0.90)	Residual ischemia is defined as iFR measurement <0.90 after operator-assessed angiographically successful PCI (residual diameter stenosis <50% in any treated lesion in the target vessel) This outcome describes the number of participants that had a residual ischemia (defined as iFR<0.90) after a PCI that appeared to be successful based on angiography.	end of procedure/intervention
Secondary	Cardiac Events	Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization or recurrent ischemia at one year after PCI	12 months
Secondary	Target Vessel Failure	Target vessel failure defined as cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization	12 months
Secondary	Quality of Life Change From Baseline to 12 Months Follow-up	Quality of life (assessed by the Seattle Angina Questionnaire) at baseline, 30-days, 6 months and 1 year (12 months).; Minimum score is 0 and maximum score is 100, with a high score representing a more positive quality of life score.; Outcome is the change in score from baseline to 12 months follow-up.	12 months
Secondary	Cardiac Mortality	All-cause and cardiac mortality at one year	12 months
Secondary	Target Vessel MI	Target vessel Myocardial infarction at one year	12 month
Secondary	Target Vessel Revascularization	Ischemia-driven target vessel revascularization at one year	12 month
Secondary	Recurrent Ischemia	Recurrent ischemia at one-year	12 month
Secondary	Correlation Between iFR and Angiographic Visual Interpretation	Correlation between iFR <0.90 and coronary stenosis >50% assessed by visual interpretation.; This was tested using generalized estimating equations for logistic regression to account for the correlation of observations from the same subject.; An absolute value of exactly 1 implies that a linear equation describes the relationship between iFR and visual interpretation of the angiography.; Outcome reports how well the iFR value and the visual interpretation are in agreement (for example, when iFR <0.90 and coronary stenosis >50% assessed by visual interpretation the correlation is 1).	at the end of the procedure/intervention
Secondary	Number of Participants in Which the iFR Would Become Non-significant if a Focal Stenosis Demonstrated by iFR Pullback Were Treated With PCI	Number of participants in which the iFR would become non-significant if a focal stenosis demonstrated by iFR pullback were treated with PCI	Procedural
Secondary	Differentiation	Differentiation of the cause for impaired iFR	End of procedure /intervention
Secondary	Delta iFR	Predictors of delta iFR before and after PCI, or predictors of impaired iFR Outcome is presented as the odds ratio (OR) that the post-PCI iFR will be <0.90. An OR > 1 means greater odds that the post-PCI iFR is <0.90, OR = 1 means there is no association, and OR < 1 means there is a lower odds that the post-PCI iFR is <0.90.	at the end of the procedure/intervention