Product Description
The biolimus-eluting coronary stent contains a stainless steel platform on which an abluminally coated polylactic acid (PLA) biodegradable polymer is placed that eludes biolimus-A9. (Sourced from: https://clinicaltrials.gov/ct2/show/NCT01137019)
Mechanisms of Action: Immunosuppressive
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: N/A
FDA Designation: *
Approval Status: Not Approved
Approved Countries: Colombia | United Arab Emirates
Approved Indications: None
Known Adverse Events: None
Company: Biosensors Europe
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 4: ST Elevation Myocardial Infarction|Myocardial Ischemia|Stroke|Coronary Artery Disease|Acute Coronary Syndrome|Myocardial Infarction|Thrombosis|Inflammation|Dyslipidemia|Hypertension|Angina, Stable
Phase 3: Coronary Artery Disease|Myocardial Ischemia|Coronary Disease
Phase 2: Myocardial Ischemia|Coronary Artery Disease|ST Elevation Myocardial Infarction|Coronary Thrombosis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
---|---|---|---|---|---|---|---|
2024-02-008-H01 | N/A |
Not yet recruiting |
Coronary Disease |
2027-05-23 |
2024-11-02 |
Primary Endpoints|Treatments |
|
LEADERS FREE IV (RCT) | N/A |
Recruiting |
Acute Coronary Syndrome|Angina, Stable|Angina, Unstable|Angina Pectoris|Coronary Artery Disease|Myocardial Ischemia |
2026-08-01 |
2025-03-08 |
||
ChiCTR2000041438 | N/A |
Recruiting |
Coronary Disease |
2025-12-31 |
|||
JW-PM-DCB-2024 | N/A |
Not yet recruiting |
Coronary Artery Disease|Myocardial Ischemia |
2025-12-30 |
2024-04-26 |
Primary Endpoints|Treatments |
|
REFORM | N/A |
Unknown status |
Coronary Stenosis|Coronary Restenosis|Coronary Artery Disease |
2023-04-01 |
2024-08-02 |
Primary Endpoints|Treatments|Trial Status |
|
SORTOUTXI | N/A |
Active, not recruiting |
Coronary Artery Disease |
2023-03-19 |
2023-04-27 |
Primary Endpoints |
|
JW-BA9-ISR-202001 | N/A |
Active, not recruiting |
Coronary Artery Disease |
2023-01-18 |
2023-11-19 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
2006-7041-83/hah | N/A |
Not yet recruiting |
Osteoarthritis, Knee|Total Knee Arthroplasty |
2022-10-31 |
|||
Brave | N/A |
Completed |
Coronary Artery Disease|Myocardial Ischemia |
2021-02-20 |
2021-09-23 |
Primary Endpoints|Treatments |
|
BioFreedomQCA | N/A |
Unknown status |
Myocardial Infarction|Coronary Artery Disease |
2019-09-30 |
2021-12-02 |
Primary Endpoints|Treatments|Trial Status |
|
CHOICE | N/A |
Terminated |
Myocardial Ischemia|Coronary Artery Disease |
2017-12-05 |
2019-07-10 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
EuroCTO | N/A |
Completed |
Coronary Occlusion|Angina, Stable|Dyspnea |
2016-05-01 |
2019-03-19 |
Treatments |
|
OCT SORT-OUT | N/A |
Active, not recruiting |
Myocardial Infarction|Angina Pectoris|Coronary Artery Disease |
2015-04-01 |
2019-11-14 |
||
SO VI | N/A |
Completed |
Coronary Artery Disease|Myocardial Ischemia|Angina Pectoris |
2012-07-01 |
2019-03-20 |
Treatments |
|
TRICVD1311 | P3 |
Completed |
Myocardial Ischemia|Coronary Artery Disease |
2016-07-01 |
2019-03-19 |
Treatments |
|
OPINION | P3 |
Completed |
Myocardial Ischemia|Coronary Artery Disease |
2016-07-01 |
2019-03-19 |
Treatments |
|
OPTIMA | P3 |
Unknown status |
Myocardial Ischemia|Coronary Artery Disease |
2014-12-01 |
2019-03-19 |
Treatments |
|
BEAUTY-II | P4 |
Unknown status |
Acute Coronary Syndrome|Stroke|Myocardial Infarction |
2017-08-01 |
2019-03-20 |
Treatments |
|
NEXT | P4 |
Completed |
Myocardial Ischemia|Coronary Artery Disease |
2015-10-01 |
2019-03-19 |
Treatments |
|
BESS | P4 |
Unknown status |
Coronary Artery Disease|Myocardial Ischemia |
2015-07-01 |
2019-03-19 |
Treatments |
|
NCT01502904 | P4 |
Completed |
Hypertension|Dyslipidemia|Acute Coronary Syndrome|Angina, Stable |
2015-05-01 |
2019-03-19 |
Treatments |
|
EVERBIOII | P4 |
Completed |
Coronary Artery Disease|Myocardial Ischemia |
2013-12-01 |
2019-03-19 |
Treatments |
|
CTO | P4 |
Unknown status |
Myocardial Ischemia|Coronary Artery Disease |
2013-10-01 |
2019-03-19 |
Treatments |
|
MUW-0001 | P4 |
Completed |
Inflammation|Thrombosis |
2013-08-01 |
2019-03-20 |
Treatments |
|
LONG-DES-V | P4 |
Completed |
Coronary Artery Disease|Myocardial Ischemia |
2013-05-01 |
2019-03-19 |
Treatments |