CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial

Not Applicable

Recruiting

• Conditions: Chronic Myocardial Ischemia; Refractory Angina
• Interventions: Other: Sham Treatment; Device: CardiAMP Cell Therapy System

• Registration Number: NCT03455725
• Lead Sponsor: BioCardia, Inc.

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 Group:

Subjects treated with aBMC using the CardiAMP cell therapy system

Sham Control Group:

Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-07
• Study Start: 2021-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 343

Inclusion Criteria

1. Male or female 21 to 80 years of age
2. Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
3. Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs.
4. Evidence of inducible myocardial ischemia on baseline stress testing
5. Obstructive coronary disease unsuitable for conventional revascularization
6. Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period).
7. Able to complete an exercise tolerance test on the treadmill
8. Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography.
9. 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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham procedure control	Sham Treatment	Randomized phase: Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 111 subjects will be treated with a Sham Treatment (no introduction of trans endocardial delivery catheter and no administration of autologous cells)
CardiAMP cell therapy system	CardiAMP Cell Therapy System	Roll-in phase: Up to 10 subjects with refractory chronic myocardial ischemia CCS class III-IV will be treated in an unblinded, uncontrolled roll-in phase. In the subsequent randomized phase: Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 222 Subjects will be randomized to treatment with the CardiAMP cell therapy system.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol	Baseline and 6 months visit	A superiority analysis with regards to change from Baseline in Total Exercise Time at the 6 months follow-up visit (using a Modified Bruce Protocol).

Secondary Outcome Measures

Name	Time	Method
Safety: Total Major adverse cardiac events (MACE) at 12 months follow-up	From randomisation to 12 month follow-up	Superiority analysis with regards to incidence of MACE from Randomization until the end of the 24 month follow-up period
Efficacy: Percentage of patients with at least 1 Serious Adverse Event (SAE)	From randomization to 12 Months follow-up	Superiority analysis with regards to percentage of participants with at least one SAE. From randomization until the end of the 12 month follow-up period.
Safety: overall survival at 6 months follow-up	at 6 months follow-up	A non-inferiority analysis of overall survival at 6-months will be made comparing the Treatment group to the Sham Control group using a non-inferiority margin of 10%.
Efficacy: Change of angina frequency (per week) at 12 months follow-up	Baseline and at 12 months follow-up	Superiority analysis with regards to change in angina frequency (episodes per week) at 12 month follow-up Visit versus baseline angina frequency (per week).; Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline (screening period) and in the 4 weeks before the 12-month follow-up visits.
Efficacy: Change from baseline in Total Exercise Time at 6 months follow-up	Baseline and at 6 months follow-up	Superiority analysis with regards to change from baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at 6 Month Follow-up Visit. Baseline (BL) is the average of (at least) two total exercise times measured during the screening period.
Efficacy: Change of Angina Frequency (per week) at 6 months follow-up	Baseline and at 6 months follow-up	Superiority analysis with regards to change in angina frequency at 6 month follow-up visit versus baseline (expressed as angina frequency per week).; Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline and in the 4 weeks before the 6-month follow-up visits.
Safety: Total Major adverse cardiac events (MACE) at 6 months follow-up	from randomisation to 6 months follow-up	A non-inferiority analysis with regard to Total Major Adverse Cardiac Events (MACE: defined as death, cardiac hospitalization, non-fatal myocardial infarction and stroke) at 12 month follow-up, as adjudicated by an independent clinical endpoint classification (CEC) committee with 10% margin.

Trial Locations

Locations (2)

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Wisconsin Madison; 🇺🇸 Madison, Wisconsin, United States