Coronary Artery DiseaseDEFINE PCINCT03084367
Physiologic Assessment of Coronary Stenosis Following PCI
An observational study of Coronary Artery Disease and Coronary Stenosis, run by Volcano Corporation at 28 sites in 3 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis, Angina, Unstable
- What is being tested?
- iFR pullback
- How many people
- 500 participants
- Where
- 28 sitesin 3 countries
- Study dates
- 20 Jun 2017to 18 Feb 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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 <0.90 of at least 1 stenosis
- Subjects are able and willing to comply with scheduled visits and tests and to provide informed consent.
Who cannot join
- Pregnant or planning to become pregnant for the duration of the study
- Acute STEMI (ST-elevated Myocardial Infarction) within the past 7 days
- Cardiogenic shock (sustained (>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)
Show all 14Show fewer
- 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
Trial locations and contacts
28 sites in 3 countries.
28 sites in 3 countries
United States22 sites
Emory University Hospital
Atlanta, Georgia, 30322
South Side Hospital
Bay Shore, New York, 11706
VA North Texas Health Care
Dallas, Texas, 75216
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
Atlanta VA Medical Center
Decatur, Georgia, 30033
Duke University Hospital
Durham, North Carolina, 27710
Vidant Medical Center
Greenville, North Carolina, 27835
Wellmont CVA Heart Insitute
Kingsport, Tennessee, 37660
Colorado Heart and Vascular
Lakewood, Colorado, 80204
Dartmouth Hitchcock
Lebanon, New Hampshire, 03756
VA Medical Center
Long Beach, California, 90822
Northshore Hospital
Manhasset, New York, 11030
Aurora St Lukes Medical Center
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Columbia University Medical Center/NewYork Presbyterian Hospital
New York, New York, 10032
New York Presbyterian Hospital -Weill Cornell
New York, New York, 10065
Lenox Hill Hospital
New York, New York, 10075
Miriam Hospital
Providence, Rhode Island, 02906
Rockford CV Associates
Rockford, Illinois, 61107
St Francis Hospital
Roslyn, New York, 11576
Baystate Medical Center
Springfield, Massachusetts, 01199
SUNY- Stony Brook
Stony Brook, New York, 11794
United Kingdom4 sites
Basildon Univeristy Hospital
Basildon, SS165NL
Royal Bournemouth hospital
Bournemouth, BH7 7DW
Royal Devon & Exeter NHS Foundation Trust
Exeter, EX25DW
Imperial College of London- Hammersmith Hospital
London, W12OHS
Netherlands2 sites
AMC Amsterdam
Amsterdam
VU University Medical Center
Amsterdam
About this study
Official title: DEFINE PCI: Physiologic Assessment of Coronary Stenosis Following PCI
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).
Read the 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.
- Being tested
- iFR pullback
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Angina, Unstable, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFR pullbackDiagnostic test
iFR pullback assessment post angiographically successful PCI
| Study group | Role | What they receive |
|---|---|---|
| iFR post angiographically successful PCI | Not described Receives: Diagnostic Test: iFR pullback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: end of procedure/intervention
Secondary outcomes (11)
Cardiac Events
Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization or recurrent ischemia at one year after PCI
Measured: 12 months
Target Vessel Failure
Target vessel failure defined as cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization
Measured: 12 months
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.
Measured: 12 months
Cardiac Mortality
All-cause and cardiac mortality at one year
Measured: 12 months
Target Vessel MI
Target vessel Myocardial infarction at one year
Measured: 12 month
Target Vessel Revascularization
Ischemia-driven target vessel revascularization at one year
Measured: 12 month
Recurrent Ischemia
Recurrent ischemia at one-year
Measured: 12 month
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).
Measured: at the end of the procedure/intervention
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
Measured: Procedural
Differentiation
Differentiation of the cause for impaired iFR
Measured: End of procedure /intervention
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.
Measured: at the end of the procedure/intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start20 Jun 2017
- Primary completion18 Jan 2019
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volcano Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute, Cardiovascular Research Foundation, New York
- Responsible party
- Sponsor
- Investigators
- Becky Inderbitzen, MSE, Study director, Philips (Volcano)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084367
- Sponsor's protocol ID
- 160101
- Acronym
- DEFINE PCI
- Status last verified
- Feb 2022
- First submitted
- 13 Mar 2017
- Last updated
- 10 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31648761Patel 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.
PubMed 34991824
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEFINE PCI: Physiologic Assessment of Coronary Stenosis Following PCI
- ClinicalTrials.gov ID
- NCT03084367
- Acronym / sponsor ID
- DEFINE PCI / 160101
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Volcano CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute, Cardiovascular Research Foundation, New York
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Posted 10 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iFR post angiographically successful PCI | – | Diagnostic Test: iFR pullback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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 <0.90 of at least 1 stenosis
Key exclusion criteria (14 listed)
- Pregnant or planning to become pregnant for the duration of the study
- Acute STEMI (ST-elevated Myocardial Infarction) within the past 7 days
- Cardiogenic shock (sustained (>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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iFR pullbackiFR pullback assessment post angiographically successful PCI | Diagnostic test | iFR post angiographically successful PCI |
Primary outcome
Number of Participants With Residual Ischemia (iFR <0.90)
Time frame: end of procedure/intervention
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.
11 secondary outcomes
Cardiac Events
Time frame: 12 months
Target Vessel Failure
Time frame: 12 months
Quality of Life Change From Baseline to 12 Months Follow-up
Time frame: 12 months
Cardiac Mortality
Time frame: 12 months
Target Vessel MI
Time frame: 12 month
Target Vessel Revascularization
Time frame: 12 month
Recurrent Ischemia
Time frame: 12 month
Correlation Between iFR and Angiographic Visual Interpretation
Time frame: at the end of the procedure/intervention
Number of Participants in Which the iFR Would Become Non-significant if a Focal Stenosis Demonstrated by iFR Pullback Were Treated With PCI
Time frame: Procedural
Differentiation
Time frame: End of procedure /intervention
Delta iFR
Time frame: at the end of the procedure/intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31648761Jeremias 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.
- Derived from this study: PubMed 34991824Patel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Becky Inderbitzen, MSE study director
Philips (Volcano)
28 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Stenosis, run by Volcano Corporation at 28 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, United Kingdom, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Residual Ischemia (iFR <0.90) (time frame: end of procedure/intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03084367, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.