Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT04523168
Eligibility Criteria:
Inclusion Criteria
* Age \>18
* Able to provide written informed consent and willing to participate in all required study follow-up assessments
* Symptomatic CAD with refractory angina defined as CCS class II to IV, despite optimal tolerated medical therapy
* Abnormal coronary microvascular function indices: CFR≤2.5 and/or IMR≥25
Exclusion Criteria
* Recent (within 3 months) acute coronary syndrome
* Patients with prior coronary artery bypass surgery
* Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the last 30 days
* Subjects in cardiogenic shock (systolic pressure \< 80mm/Hg, on vasopressors or intraaortic counter pulsation) at the time of consenting. Subjects who recover from cardiogenic shock by the time of consenting are eligible.
* Obstructive CAD on coronary angiography (\>70% stenosis or 50-70% stenosis with iFR\<0.89 or FFR\<0.8 in epicardial artery)
* Inability to perform invasive coronary flow evaluation and/or measure CFR and IMR in the LAD
* Severe valvular heart disease
* LVEF\<30%
* Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
* Patient with a pacemaker electrode in the CS
* Mean right atrial pressure \>15 mmHg
* Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava (SVC) as demonstrated on angiogram
* CS diameter at the site of planned implantation greater than 13mm or less than 9.5 mm as measured by angiogram
* Severe chronic obstructive pulmonary disease (COPD) indicated by a forced expiratory volume in one second that is less than 55 percent of the predicted value
* Tricuspid valve replacement or repair (tissue or mechanical)
* Chronic renal failure (serum creatinine \>2mg/dL), and or on chronic hemodialysis
* Moribund, or with comorbidities limiting life expectancy to less than one year
* Known severe reaction to required procedural medication
* Known allergy to stainless steel or nickel
* Magnetic Resonance Imaging (MRI) within 8 weeks of Reducer implantation
* Participation in another ongoing investigational trial
* Additional factors deemed unsuitable for trial enrollment per discretion of principal investigator
* Inmates
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04523168
Study Brief:
Protocol Section:
NCT04523168