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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT04606459
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 and ≤85 years
* Chronic coronary syndrome (including patients with anginal equivalents) refractory angina CCS class III-IV despite guideline-directed medical therapy
* Evidence of reversible ischemia on non-invasive testing
* Evidence of microvascular disease as diagnosed invasively by at least one of the following:
1. index of microvascular resistances (IMR) \>25 and/or
2. coronary flow reserve (CFR) \<2.0) with fractional flow reserve (FFR)\>0.8.
* Willingness to participate and ability to understand, read and sign the informed consent document before enrollment in the trial.
Exclusion Criteria:
Subjects presenting at least one of the following criteria will not be enrolled in the trial
* Recent (within 3 months) acute coronary syndrome
* Recent (within 6 months) revascularization by percutaneous coronary intervention (PCI, stent) or coronary artery by-pass surgery (CABG)
* Recent (within 30 days) unsuccessful PCI
* Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
* Left ventricular ejection fraction of \<30%
* Mean right atrial pressure \>15mmHg
* Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava \[SVC\]) as demonstrated by angiogram
* CS diameter at the site of planned Reducer implantation greater than 13mm or less than 9.5mm 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
* Severe valvular heart disease
* A pacemaker electrode in the coronary sinus
* Tricuspid valve replacement or repair
* 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 medications
* Known allergy to stainless steel or nickel
* Need for Magnetic Resonance Imaging (MRI) within 8 weeks after reducer implantation
* Contraindication to dual antiplatelet therapy
* Female of childbearing potential (last menstruation within the last 12 months or who did not undergo tubal ligation, ovariectomy or hysterectomy)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04606459
Study Brief:
Protocol Section:
NCT04606459