Status:
ACTIVE_NOT_RECRUITING
CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial
Lead Sponsor:
BioCardia, Inc.
Conditions:
Refractory Angina
Chronic Myocardial Ischemia
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment Treatment Gro...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female 21 to 80 years of age
- Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
- Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs.
- Evidence of inducible myocardial ischemia on baseline stress testing
- Obstructive coronary disease unsuitable for conventional revascularization
- Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period).
- Able to complete an exercise tolerance test on the treadmill
- Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography.
- Qualification of a pre-procedure screening of bone-marrow aspiration
- Exclusion Criteria
- Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
Exclusion
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT03455725
Start Date
June 30 2021
End Date
December 1 2027
Last Update
January 6 2026
Active Locations (2)
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1
University of Florida
Gainesville, Florida, United States, 32610
2
University of Wisconsin Madison
Madison, Wisconsin, United States, 53792