Trials / Suspended
SuspendedNCT06071702
IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
- Status
- Suspended
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (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, early feasibility study 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) alloybased stent coated with a bioresorbable polymer mesh which is embedded with drug, mounted on a Rapid Exchange (RX) delivery system. |
Timeline
- Start date
- 2025-08-07
- Primary completion
- 2025-08-07
- Completion
- 2026-08-10
- First posted
- 2023-10-06
- Last updated
- 2025-09-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06071702. Inclusion in this directory is not an endorsement.