Trials / Unknown
UnknownNCT04236609
Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global
ABILITY Diabetes Global
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3,050 (actual)
- Sponsor
- Concept Medical Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome
Detailed 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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Abluminus DES+ Sirolimus Eluting Stent System (SES) | The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical |
| DEVICE | XIENCE Everolimus Eluting Coronary Stent System (XIENCE family) | The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA |
Timeline
- Start date
- 2020-06-15
- Primary completion
- 2023-10-30
- Completion
- 2024-09-30
- First posted
- 2020-01-22
- Last updated
- 2023-03-27
Locations
90 sites across 21 countries: Australia, Austria, Bangladesh, Belgium, Brazil, Czechia, France, Germany, India, Ireland, Italy, Malaysia, Mexico, Netherlands, Poland, Singapore, South Korea, Sweden, Switzerland, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT04236609. Inclusion in this directory is not an endorsement.