IRB Study Number 25-299
Status Recruiting
Institute Heart and Vascular Institute
Description
The clinical investigation purpose is to assess safety, feasibility and efficacy of percutaneous endovascular catheter-facilitated intramyocardial delivery of XC001 in patients with refractory angina (RA) due to obstructive coronary artery disease (CAD).
Inclusion Criteria
Males and females, age 18 to 85 years, inclusive, at the time of signing the ICF.
Diagnosis of chronic angina due to obstructive CAD that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) (as defined by ESC Joint Study Group on the Treatment of Refractory Angina Refractory, Mannheimer et al, EHJ 2002 and the 2013 ESC guidelines on the management of stable coronary artery disease, Montalescot et al, EHJ 2013; and Jolicoeur et al 2008).
Angina class II-IV as measured by CCS Functional Classification of Angina Pectoris.
Exclusion Criteria
- Any of the following:
a. ST-Elevation or non-ST elevation myocardial infarction (STEMI or NSTEMI) not requiring revascularization, transmural MI, or cerebral vascular accident within the past 60 days prior to the screening visit.
b. Uncontrolled hypercholesterolemia defined as low-density lipoprotein (LDL) above 190 mg/dL.
c. Uncontrolled hypertension (systolic blood pressure [BP] >180 mmHg, diastolic BP >100 mmHg) despite maximal medical treatment.
d. Current untreated malignant ventricular arrhythmias (with episode of sustained or non-sustained ventricular tachycardia (VT) in last 30 days; suspected/probable/definite).
e. Current untreated bradyarrhythmia (<50 bpm) for which a new artificial pacemaker placement is anticipated during the study period. A current pacemaker is allowed.
f. Congestive heart failure defined as New York Heart Association Function Class III or IV or left ventricular ejection fraction < 25% within the 6 weeks prior to the screening visit (or as assessed by the screening contrast Echo).
g. Anginal episodes that routinely require the administration of opiates.
Moderate to severe aortic valve stenosis (defined as Doppler echocardiography determined peak pressure gradient that exceeds 40 mm Hg (or Vmax >3.2 m/s) and/or subjects with a mechanical valve in the aorta valve position.
Presence of a ventricular thrombus (as defined by contrast transthoracic echocardiography at screening). Subjects may be rescreened after 6 weeks of adequate treatment and absence of ventricular thrombus by echocardiography.
