Coronary Artery Disease Clinical Trial
— REFINE PCIOfficial title:
Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI (REFINE PCI)
NCT number | NCT05491668 |
Other study ID # | 2022P000479 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 11, 2022 |
Est. completion date | October 2024 |
Traditionally, the severity of a blockage (stenosis) in a coronary artery has been determined by visual angiographic assessment of the diameter of the artery at the level of a blockage compared to a normal healthy area of the same artery. With the advent of invasive physiological testing to assess coronary blood flow, multiple clinical trials have demonstrated a clinical benefit to a physiology-guided percutaneous coronary intervention (PCI) approach. However, despite this and the potential for significant variation in the interpretation of coronary artery stenosis severity by visual angiography alone to guide PCI, invasive physiologic indices remain significantly under-utilized. The purpose of this study is to investigate the physiologic significance of coronary lesions deemed angiographically severe by visual estimation that are planned for PCI. The investigators plan to perform blinded physiologic assessment pre and post PCI. The primary aim of the study is to determine whether a subset of lesions visually estimated as severe by angiography treated with stent placement/PCI may in fact not be physiologically significant when assessed invasively, and thus PCI could safely be deferred in these patients. A secondary aim is to evaluate physiologic assessment post PCI to detect residual ischemia that could be utilized to optimize stent placement.
Status | Recruiting |
Enrollment | 107 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age >/= 18 years - Patient provides written informed consent - Clinical presentation with stable coronary artery disease or acute coronary syndromes (unstable angina, Non-ST Elevation Myocardial Infarction (NSTEMI), or ST Elevation Myocardial Infarction (STEMI)) - Scheduled for clinically indicated cardiac catheterization - At least one lesion with angiographic severity visually estimated to be >/= 70% diameter stenosis that is deemed suitable for PCI - The operator plans to perform PCI on an ad hoc or planned basis - The target lesion is not planned for assessment by invasive physiology Exclusion Criteria: - Failure to provide signed informed consent - Culprit vessel of acute ST Elevation Myocardial Infarction (STEMI) - Culprit vessel of Non-ST Elevation Myocardial Infarction (NSTEMI) - Thrombolysis In Myocardial Infarction (TIMI) flow less than grade 3 at baseline or visible thrombus - Chronic total occlusion (CTO) in the target vessel - Target vessel is supplied by major collaterals or supplies major collaterals to a CTO - Target lesion involves the left main coronary artery - Prior history of coronary artery bypass grafting (CABG) to the target vessel, except if bypass graft is occluded - Previously known untreated severe valvular heart disease - Previously known left ventricular ejection fraction <30% - Sustained ventricular arrhythmias - Patients who are currently pregnant (pregnancy testing will be performed as per standard cardiac catheterization laboratory protocol) |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | Opsens, Inc. |
United States,
Collison D, McClure JD, Berry C, Oldroyd KG. A randomized controlled trial of a physiology-guided percutaneous coronary intervention optimization strategy: Rationale and design of the TARGET FFR study. Clin Cardiol. 2020 May;43(5):414-422. doi: 10.1002/clc.23342. Epub 2020 Feb 10. — View Citation
Davies JE, Sen S, Dehbi HM, Al-Lamee R, Petraco R, Nijjer SS, Bhindi R, Lehman SJ, Walters D, Sapontis J, Janssens L, Vrints CJ, Khashaba A, Laine M, Van Belle E, Krackhardt F, Bojara W, Going O, Harle T, Indolfi C, Niccoli G, Ribichini F, Tanaka N, Yokoi H, Takashima H, Kikuta Y, Erglis A, Vinhas H, Canas Silva P, Baptista SB, Alghamdi A, Hellig F, Koo BK, Nam CW, Shin ES, Doh JH, Brugaletta S, Alegria-Barrero E, Meuwissen M, Piek JJ, van Royen N, Sezer M, Di Mario C, Gerber RT, Malik IS, Sharp ASP, Talwar S, Tang K, Samady H, Altman J, Seto AH, Singh J, Jeremias A, Matsuo H, Kharbanda RK, Patel MR, Serruys P, Escaned J. Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834. doi: 10.1056/NEJMoa1700445. Epub 2017 Mar 18. — View Citation
De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27. Erratum In: N Engl J Med. 2012 Nov;367(18):1768. Mobius-Winckler, Sven [corrected to Mobius-Winkler, Sven]. — View Citation
Gotberg M, Christiansen EH, Gudmundsdottir IJ, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Ohagen P, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Todt T, Venetsanos D, James SK, Karegren A, Nilsson M, Carlsson J, Hauer D, Jensen J, Karlsson AC, Panayi G, Erlinge D, Frobert O; iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823. doi: 10.1056/NEJMoa1616540. Epub 2017 Mar 18. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The percentage of physiologically non-significant lesions observed | Non-significant lesions defined as a diastolic pressure ratio (dPR) = 0.89 (range 0-1), expressed as mean, standard deviation, and percentage of total number of assessments | Time of procedure | |
Primary | Correlation of the operator visual angiographic assessment of stenosis severity with quantitative coronary angiography (QCA) and resting non-hyperemic pressure resting indices (NHPR) | Visual stenosis severity and QCA are numerical variables reported as percentages, and expressed as mean and standard deviation. NHPR is a numerical variable from 0 to 1, expressed as mean and standard deviation. Pearson correlation coefficient used to express correlation between two variables. | Within 30 days post procedure | |
Primary | Correlation between QCA and NHPR | QCA is a numerical variable reported as a percentage, and expressed as mean and standard deviation. NHPR is a numerical variable from 0 to 1, expressed as mean and standard deviation. Pearson correlation coefficient used to express correlation between two variables. | Within 30 days post procedure | |
Secondary | Correlation of the post-PCI NHPR with burden of angina as assessed via the Seattle Angina Questionnaire at 30 days post PCI | NHPR is a numerical variable from 0 to 1, expressed as mean and standard deviation. Seattle Angina Questionnaire assesses patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, expressed as mean and standard deviation. Pearson correlation coefficient used to express correlation between two variables. | Day 30 post PCI | |
Secondary | Change in angina as assessed via the Seattle Angina Questionnaire at baseline and 30 days after PCI, need for titration for anti-anginal medications, or need for repeat coronary angiography within 30 days of the procedure. | Seattle Angina Questionnaire assesses patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, expressed as mean and standard deviation. Comparison of baseline and 30 days post PCI involves comparison of numerical variables and uses the Student's paired t test or Wilcoxon signed rank test. Need for titration for anti-anginal medications and need for repeat coronary angiography within 30 days of the procedure are descriptive data (Yes, No) | Day 30 post PCI |
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