Clinical trial NCT04523168: Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction
Official title: A Phase II Study Testing the Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Microvascular Dysfunction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to evaluate the role of a novel implantable device, called The Neovasc Reducer™ System, in improving microvascular function, symptoms and quality of life in symptomatic patients with coronary microvascular dysfunction.


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

Primary outcomes:
measure: Change in Coronary Flow Reserve (CFR)
timeFrame: Baseline, 120 days
Secondary outcomes:
measure: Seattle Angina Questionnaire (SAQ)
timeFrame: 120 days
measure: Change in Canadian Cardiovascular Society (CCS) Angina Class
timeFrame: Baseline, 120 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman
role: PRINCIPAL_INVESTIGATOR
References: