Trials / Terminated
TerminatedNCT03773081
SOLVE-ACS: Bioresorbable Magnesium-Stents Magmaris in ACS Lesions
SOLVE-ACS: Prospective Multicenter Evaluation of the Performance of the Bioresorbable Magnesium-Stents Magmaris in Patients With Acute Coronary Syndrome (ACS)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Charite University, Berlin, Germany · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the registry is to investigate the clinical performance of the Magmaris Magnesium Stent in STE-ACS and NSTE-ACS patients.
Detailed description
The Magmaris Magnesium-Stent is indicated for improving luminal diameter and stabilize culprit lesions in patients with coronary artery disease (CAD) including ST-segment elevation (STE-) as well as Non-ST-segment elevation (NSTE-) acute coronary syndrome (ACS). Patients scheduled for this registry, must have one angiographic clear detectable ACS-causing culprit lesion with a reference diameter and a lesion length, which closely match the nominal Magmaris reference diameter and length. Primary endpoint will be the procedural angiographical success at the end of PCI, defined as successful Magmaris implantation at the "culprit lesion site" with less than 30% final stenosis (by visual estimation) and distal TIMI 3 flow. Secondary endpoints will include clinical and angiographic parameters as well as parameters gained through OCT-imaging.
Conditions
- Acute Coronary Syndrome
- STEMI - ST Elevation Myocardial Infarction
- NSTEMI - Non-ST Segment Elevation MI
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implantation of the Magmaris scaffold | Subjects will undergo a PCI for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice. Maximum of one single ACS-causing de novo lesions in one separate major epicardial vessels is allowed. |
Timeline
- Start date
- 2018-08-21
- Primary completion
- 2019-09-15
- Completion
- 2019-09-15
- First posted
- 2018-12-12
- Last updated
- 2019-09-17
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03773081. Inclusion in this directory is not an endorsement.