CardiAMP CMI Randomized Controlled Pivotal Trial in Patients With Chronic Myocardial Ischemia and Refractory Angina
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
Summary
- Conditions
- Chronic Myocardial Ischemia
- Refractory Angina
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Prospective, multi-center, 2:1 randomized (Treatment vs Sham Control), blinded trial comparing 2 paralel groups of patients with CMI treated with CardiAMP cell therapy system vs sham treatment.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Quadruple-blinded, placebo-controlled study. Patients, investigators, the CRO, core labs and the sponsor will be blinded for individual treatment adjudication.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 80 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03455725
- Collaborators
- Not Provided
- Investigators
- Not Provided