Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI

NCT05491668 | Recruiting DMC FDA Device

• 1 other identifier: 2022P000479
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Invasive physiology; Angiography; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Correlation of the post-PCI NHPR with burden of angina as assessed via the Seattle Angina Questionnaire at 30 days post PCI

  Day 30 post PCI

• 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.

  Day 30 post PCI

Study Arms (1)

Coronary Physiology Assessment

Patients undergoing coronary angiogram who are found to have \>/= 70% coronary stenosis and planned for percutaneous coronary intervention (PCI)/stent placement, will undergo pre and post PCI invasive physiologic assessment with a coronary pressure-sensing wire (OpSens OptoWire III) using non-hyperemic pressure ratio (NHPR) indices (diastolic pressure ratio \[dPR\]). Both the patient and interventional cardiologist will be blinded to the results of the invasive physiologic assessment. Angiogram co-registration will be performed on pullback of coronary pressure-sensing wire.

Diagnostic Test: Non-hyperemic pressure ratio assessment pre and post PCI

Interventions

Non-hyperemic pressure ratio assessment pre and post PCI DIAGNOSTIC_TEST

Pre and post PCI invasive physiologic assessment

Also known as: OpSens OptoWire III

Coronary Physiology Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population will consist of male and female subjects from the general interventional cardiology population who are scheduled for coronary angiogram at Beth Israel Deaconess Medical Center

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Opsens, Inc.: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 28317458 BACKGROUND

• 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.

  PMID: 28317438 BACKGROUND

• 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.

  PMID: 22924638 BACKGROUND

• 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.

  PMID: 31648761 BACKGROUND

• 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.

  PMID: 32037592 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Eric Osborn, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Osborn, MD, PhD

CONTACT

617-632-7452; eosborn@bidmc.harvard.edu

Killian McCarthy, MB, BCh, BAO

CONTACT

617-632-0544; kmccar10@bidmc.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Interventional Cardiology Fellowship, Beth Israel Deaconess Medical Center; Assistant Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 8, 2022
• Study Start: October 11, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)