Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses

NCT ID: NCT02328820

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 455 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2021-04-30

Brief Summary

This study evaluates the prognostic value and therapeutic potential of combined pressure and flow measurements when evaluating a coronary artery stenosis. Lesions with intact coronary flow reserve (CFR) despite a reduced fractional flow reserve (FFR) will receive optimal medical therapy. Only lesions with a simultaneous reduction in both CFR and FFR will be treated with percutaneous coronary intervention (PCI).

Detailed Description

Pressure and flow represent the two physiologic variables that can be measured directly inside a coronary artery. Already pressure measurements have proven their clinical value in the form of fractional flow reserve (FFR). However, myocardial function can remain intact with sufficient flow, even at a low perfusion pressure. Therefore, combined pressure and flow measurements provide a more complete description of physiologic stenosis severity as a guide to medical treatment versus revascularization. Based on existing work relating the most common flow measurement, coronary flow reserve (CFR), to FFR and linking both variables with subsequent prognosis, we hypothesize that lesions with an intact CFR>=2.0 can be reasonably treated with medical therapy despite a reduced FFR<=0.8.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

All patients

All lesions undergo simultaneous assessment with a combined pressure and flow sensor

Group Type: OTHER

Percutaneous coronary intervention (PCI)

Intervention Type: OTHER

For lesions with both FFR\<=0.8 and CFR\<2.0

Optimal medical therapy (OMT)

Intervention Type: OTHER

For lesions with FFR\>0.8 or CFR\>=2.0 or both

Interventions

Percutaneous coronary intervention (PCI)

For lesions with both FFR\<=0.8 and CFR\<2.0

Intervention Type: OTHER

Optimal medical therapy (OMT)

For lesions with FFR\>0.8 or CFR\>=2.0 or both

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Eligible for PCI based on local practice standards during the current procedure (PCI cannot be staged).
• At least one epicardial stenosis of ≥50% diameter (by visual or quantitative assessment) and meeting the following criteria as determined by the operator based on either a prior or the current diagnostic angiogram:

• <100% diameter (not a chronic, total occlusion);
• in a native coronary artery (including side branches but excludes bypass grafts);
• of ≥2.5mm reference diameter (near the level of the stenosis);
• and supplies sufficiently viable myocardium (exclude regions of known, prior, transmural myocardial infarction).
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

• Anatomic exclusions:

• Prior CABG.
• Preferred treatment strategy for revascularization would be CABG based on local practice standards.
• Left main coronary artery disease requiring revascularization.
• Extremely tortuous or calcified coronary arteries precluding intracoronary physiologic measurements. Operators may also exclude subtotal or similar high-grade lesions, which in their judgment may be threatened by ComboWire placement.
• Known severe LV hypertrophy (septal wall thickness at echocardiography of >13 mm).
• Clinical exclusions:

• Inability to receive intravenous adenosine (for example, severe reactive airway disease, marked hypotension, or high-grade AV block without pacemaker).
• Recent (within 3 weeks prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion).
• Culprit lesions (based on clinical judgment of the operator) for either STEMI or non-STEMI cannot be included.
• Severe cardiomyopathy (LV ejection fraction <30%).
• Planned need for cardiac surgery (for example, valve surgery, treatment of aortic aneurysm, or septal myomectomy).
• General exclusions:

• A life expectancy of less than 2 years.
• Inability to sign an informed consent, due to any mental condition that renders the subject unable to understand the nature, scope, and possible consequences of the trial or due to mental retardation or language barrier.
• Potential for non-compliance towards the requirements for follow-up visits.
• Participation or planned participation in another cardiovascular clinical trial before completing the 24 month follow-up.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

Volcano Corporation

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Nils Johnson

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nils Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Medical School at Houston

Jan J Piek, MD, PhD

Role: STUDY_DIRECTOR

Academic Medical Center (AMC), Amsterdam

Locations

Aarhus University Hospital

Aarhus, , Denmark

Catholic University of the Sacred Heart

Rome, , Italy

Gifu Heart Center

Gifu, , Japan

Toda Central General Hospital

Toda, , Japan

Tokyo Medical University

Tokyo, , Japan

Tsuchiura Kyodo

Tsuchiura, , Japan

Amsterdam UMC - location AMC

Amsterdam, , Netherlands

Amsterdam UMC - location VUmc

Amsterdam, , Netherlands

Tergooi Hospital

Blaricum, , Netherlands

Amphia Hospital

Breda, , Netherlands

Hospital Clinico San Carlos

Madrid, , Spain

Royal Free Hospital

London, , United Kingdom

Countries

Denmark; Italy; Japan; Netherlands; Spain; United Kingdom

References

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Reference Type: BACKGROUND

PMID: 22340827 (View on PubMed)

van de Hoef TP, van Lavieren MA, Damman P, Delewi R, Piek MA, Chamuleau SA, Voskuil M, Henriques JP, Koch KT, de Winter RJ, Spaan JA, Siebes M, Tijssen JG, Meuwissen M, Piek JJ. Physiological basis and long-term clinical outcome of discordance between fractional flow reserve and coronary flow velocity reserve in coronary stenoses of intermediate severity. Circ Cardiovasc Interv. 2014 Jun;7(3):301-11. doi: 10.1161/CIRCINTERVENTIONS.113.001049. Epub 2014 Apr 29.

Reference Type: BACKGROUND

PMID: 24782198 (View on PubMed)

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

PMID: 32062172 (View on PubMed)

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Other Identifiers

NL48375.018.14

Identifier Type: OTHER

Identifier Source: secondary_id

HSC-MS-14-0442

Identifier Type: -

Identifier Source: org_study_id