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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magmaris | Device | 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. |
| |
| Freesolve | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | The primary endpoint will be Target Lesion Failure (TLF) at 12 months. TLF is a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven Target Lesion Revascularization (TLR). | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marina Gattiglio, Dr. | Contact | +41754295843 | marina.gattiglio@teleflex.com |
| Name | Affiliation | Role |
|---|---|---|
| Stefano Galli, MD | Centro Cardiologico Monzino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairns Hospital | Completed | Cairns | 4870 | Australia | ||
| Heart Center Segeberger Kliniken |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42368841 | Derived | Wolbert S, Schmidt T, Wittek F, Mayer B, Raake P, Bongiovanni D, Torzewski J. One-year outcomes of bioresorbable magnesium scaffold implantation in complex coronary lesions. Front Cardiovasc Med. 2026 Jun 12;13:1854686. doi: 10.3389/fcvm.2026.1854686. eCollection 2026. |
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The primary outcome data will be shared after the publication of it.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Recruiting |
| Bad Segeberg |
| 23795 |
| Germany |
|
| Krankenhaus Buchholz | Completed | Buchholz | 21244 | Germany |
| Klinikum Westfalen, Knappschaft KH | Completed | Dortmund | 44309 | Germany |
| Klinikum Herford | Completed | Herford | 32049 | Germany |
| Herz-und Gefäßzentrum Oberallgäu-Kempten | Completed | Kempten | Germany |
| Centro Cardiologico Monzino | Recruiting | Milan | Lombardy | 20138 | Italy |
|
| Daugavpils Regional Hospital | Completed | Daugavpils | LV-5417 | Latvia |
| 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie | Recruiting | Lublin | Poland |
|
| SUSCCH Banska Bystrica | Completed | Banská Bystrica | 974 01 | Slovakia |
| Lindenhofspital | Recruiting | Bern | 3001 | Switzerland |
|
| Centre Hospitalier Universitaire Vaudois | Recruiting | Lausanne | 1005 | Switzerland |
|
| Solothurner Spitäler AG | Recruiting | Olten | 4600 | Switzerland |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |