Trials / Active Not Recruiting
Active Not RecruitingNCT05364697
IonMAN Trial- First in Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
IonMAN Trial-First in Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Medinol Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multi-center, single-arm, open-label, First in Human clinical trial to provide preliminary evidence for the safety and efficacy of the novel IoNIR stent system.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IoNIR Ridaforolimus-Eluting Coronary Stent System | The IoNIR Ridaforolimus-Eluting Coronary Stent System is a sterile single-use device/drug combination product, comprised of a cobalt chromium (CoCr) alloy-based stent coated with a bioresorbable polymer mesh which is embedded with drug, mounted on a Rapid Exchange (RX) delivery system. |
Timeline
- Start date
- 2022-08-30
- Primary completion
- 2024-09-30
- Completion
- 2029-12-01
- First posted
- 2022-05-06
- Last updated
- 2024-11-21
Locations
4 sites across 2 countries: Brazil, Israel
Source: ClinicalTrials.gov record NCT05364697. Inclusion in this directory is not an endorsement.