Trials / Recruiting
RecruitingNCT04679740
Resorbable Magnesium Scaffolds Registry
RMS (Resorbable Magnesium Scaffolds) Registry
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,106 (estimated)
- Sponsor
- Biotronik AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The registry follows the ESC/EACTS guideline and further investigates the clinical performance and short-term safety of RMS (Resorbable Magnesium Scaffolds) in a real world setting within the scope of its intended use without further (medical related) exclusion criteria according to their respective instructions for use (IFU).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Magmaris | MAGMARIS is indicated for improving luminal diameter in the treatment of de novo native coronary artery lesions in patients with symptomatic coronary artery disease. The reference vessel diameter should closely match the scaffold nominal diameter. The treated lesion length should be less than the nominal scaffold length. |
| DEVICE | Freesolve | Freesolve is indicated for improving luminal diameter in the treatment of de novo native coronary artery lesions in patients with symptomatic coronary artery disease. The reference vessel diameter should closely match the scaffold nominal diameter. The treated lesion length should be less than the nominal scaffold length. |
Timeline
- Start date
- 2020-11-18
- Primary completion
- 2030-05-01
- Completion
- 2030-05-01
- First posted
- 2020-12-22
- Last updated
- 2025-11-21
Locations
13 sites across 7 countries: Australia, Germany, Italy, Latvia, Poland, Slovakia, Switzerland
Source: ClinicalTrials.gov record NCT04679740. Inclusion in this directory is not an endorsement.