ABILITY Diabetes Global
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Coronary Syndrome
- Coronary (Artery) Disease
- Diabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Target lesions should be treated in accordance with the randomization schedule after meeting the clinical and angiographic inclusion and exclusion criteria following the instruction for use of the study stent. Additional lesions (other vessels) may be staged up to 45 days post-index procedure but must be treated with the same stent. Dual antiplatelet therapy must be prescribed in alignment with the Instructions for Use of the DES and the guidelinesMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
This study aims to determine which DES will best treat the diabetic population. Specifically, the research question of this trial is to evaluate the use of a novel sirolimus-eluting stent coated with drug-eluting polymer after crimping on the balloon as compared to the standard-of-care EES in the tr...
This study aims to determine which DES will best treat the diabetic population. Specifically, the research question of this trial is to evaluate the use of a novel sirolimus-eluting stent coated with drug-eluting polymer after crimping on the balloon as compared to the standard-of-care EES in the treatment of de novo coronary artery disease in patients with diabetes mellitus. ABILITY is a prospective, multi-center, multinational, randomized, open label, 2-arm parallel group, post-approval study.
Tracking Information
- NCT #
- NCT04236609
- Collaborators
- Not Provided
- Investigators
- Study Chair: Roxana Mehran Mount Sinai Heart
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