Saline-induced Distal to Aortic Coronary Pressure Ratio vs. Resting and Hyperemic Indices of Coronary Artery Stenosis Severity

NCT ID: NCT04284345

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2024-01-01

Brief Summary

The presence of inducible myocardial ischemia is considered as the prerequisite for the clinical benefit of coronary revascularization. In this regard, the introduction of invasive pressure-derived physiological indices to guide myocardial revascularization represented a major breakthrough for the treatment of patients with coronary artery disease (CAD), by moving the focus of coronary revascularization from anatomy to physiology . The main premise of coronary physiology is to permit determination of the functional significance of individual stenoses on a per-vessel basis, measurable at the time of clinical decision-making process, thus providing an objective marker to identify ischemic lesions, and therefore patients, most likely to benefit from coronary revascularization .

Fractional flow reserve (FFR) is the most widely used pressure-derived invasive physiological index for coronary lesion assessment in contemporary clinical practice. FFR is calculated as the ratio of the mean distal coronary pressure (Pd) to the mean proximal coronary pressure (Pa) across a stenosis during maximal hyperaemia, a condition that is commonly achieved by the intracoronary or intravenous administration of a potent vasodilator agent, such as adenosine. Based on the results of landmark clinical trials, most recent guidelines recommend the use of FFR to identify hemodynamically significant coronary lesions in patients with stable CAD. Despite this, the worldwide adoption of FFR into current clinical practice remains limited , accounting for only 9.8% of coronary procedures in Switzerland . Potential reasons for the low adoption rate of coronary physiology include technical challenges and time consumption related to FFR measurements, inadequate or lack of reimbursement, physician preferences, patient-related discomfort, contraindications and costs associated with adenosine, or in certain countries, no availability of adenosine.

The low use of FFR in clinical practice provided a rationale for the development of new invasive physiology indices. By negating the need for administration of pharmacologic agents such as adenosine, saving time, and reducing costs and side effects, hyperaemia-free pressure-derived physiological indices were developed to increase adoption of physiology-guided coronary revascularization into routine clinical practice.

Conditions

Coronary Stenosis

Study Design

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

Study Groups

Saline Pd/Pa

Eligible subjects will undergo invasive coronary physiology measurements including whole cycle resting Pd/Pa, iFR, RFR, cFFR, Saline Pd/Pa and FFR

Group Type: EXPERIMENTAL

Saline Pd/Pa

Intervention Type: PROCEDURE

Use of a ≥6F guiding catheter and the Verrata pressure guidewire. Administration of intracoronary nitroglycerin.

Verrata normalisation and placement of the Verrata sensor ≥3 vessel-diameter beyond the stenosis.

Whole cycle resting Pd/Pa and resting iFR measurements.

Measurement of contrast FFR: record 5 baseline heart beats, injection of contrast media, 10 ml in the left coronary system, 8 ml in the right coronary system, measure minimal Pd/Pa under stable hyperaemia.

Adenosine FFR: measurement: record 5 baseline heart beats, injection of intracoronary adenosine, 200 mcg in the left coronary system, 100 mcg in the right coronary system, measure minimal Pd/Pa under stable hyperaemia.

Saline-induced Pd/Pa measurement: record 5 baseline heart beats, injection of saline using the ACIST system during 5 heart beats, measure minimal Pd/Pa under stable hyperaemia.

Perform pressure guidewire pullback and check for drift: drift ±0.02 is accepted, if ≥0.03, repeat measurement.

Interventions

Saline Pd/Pa

Use of a ≥6F guiding catheter and the Verrata pressure guidewire. Administration of intracoronary nitroglycerin.

Verrata normalisation and placement of the Verrata sensor ≥3 vessel-diameter beyond the stenosis.

Whole cycle resting Pd/Pa and resting iFR measurements.

Measurement of contrast FFR: record 5 baseline heart beats, injection of contrast media, 10 ml in the left coronary system, 8 ml in the right coronary system, measure minimal Pd/Pa under stable hyperaemia.

Adenosine FFR: measurement: record 5 baseline heart beats, injection of intracoronary adenosine, 200 mcg in the left coronary system, 100 mcg in the right coronary system, measure minimal Pd/Pa under stable hyperaemia.

Saline-induced Pd/Pa measurement: record 5 baseline heart beats, injection of saline using the ACIST system during 5 heart beats, measure minimal Pd/Pa under stable hyperaemia.

Perform pressure guidewire pullback and check for drift: drift ±0.02 is accepted, if ≥0.03, repeat measurement.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subject is ≥18 years of age.
• Subject must be willing to sign a Patient Informed Consent (PIC).
• Coronary artery disease with over 50% angiographic diameter stenosis on visual assessment, undergoing clinically indicated invasive physiological assessment by means of FFR.
• Assessment of non culprit arteries with over 50% angiographic diameter stenosis on visual assessment, in patients presenting with NSTEMI.

Exclusion Criteria

• Pregnant and/or breastfeeding females.
• Known allergies to: heparin, contrast medium, adenosine.
• Contra-indication to adenosine.
• Severe renal failure (eGFR ≤ 30 ml/min/m2).
• Ostial stenosis in both the left and right coronary arteries.
• Presence of a chronic total occlusion.
• History of coronary artery bypass graft.
• Acute coronary syndrome.
• Acute myocardial infarction within the preceding two weeks.
• Severe valvular heart disease.
• Left main disease.
• Documented left ventricular ejection fraction (LVEF) ≤30% as documented within maximum 6 months prior to the procedure.
• Decompensated congestive heart failure.
• Extreme hypotension (systolic blood pressure <100 mmHg)
• Extreme bradycardia (<40 bpm).

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

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

IGLESIAS Juan Fernando

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Geneva University Hospitals

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

2019-00910

Identifier Type: -

Identifier Source: org_study_id