Registry of Resorbable Magnesium Scaffolds for Coronary Artery Disease
RMS (Resorbable Magnesium Scaffolds) Registry
This study is testing how well resorbable magnesium scaffolds work and if they are safe for people with coronary artery disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biotronik AG Industry-sponsored |
| Locations | 13 sites (Cairns and 12 other locations) |
| Trial ID | NCT04679740 on ClinicalTrials.gov |
What this trial studies
This registry aims to evaluate the clinical performance and short-term safety of resorbable magnesium scaffolds (RMS) in patients with coronary artery disease. It follows the guidelines set by the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery, collecting real-world data on the use of Magmaris scaffolds. The study includes patients who meet the instructions for use without additional exclusion criteria, allowing for a broad assessment of the device's effectiveness in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this registry are patients diagnosed with coronary artery disease who are eligible for treatment with resorbable magnesium scaffolds according to the instructions for use.
Not a fit: Patients who do not meet the inclusion criteria or have contraindications as per the instructions for use may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the safety and efficacy of resorbable magnesium scaffolds, potentially improving treatment options for patients with coronary artery disease.
How similar studies have performed: While this registry approach is not novel, similar studies have shown promising results in evaluating the safety and effectiveness of resorbable scaffolds in coronary interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * According to the IFU Exclusion Criteria: * According to the IFU
Where this trial is running
Cairns and 12 other locations
- Cairns Hospital — Cairns, Australia (Completed)
- Heart Center Segeberger Kliniken — Bad Segeberg, Germany (Recruiting)
- Krankenhaus Buchholz — Buchholz, Germany (Completed)
- Klinikum Westfalen, Knappschaft KH — Dortmund, Germany (Completed)
- Klinikum Herford — Herford, Germany (Completed)
- Herz-und Gefäßzentrum Oberallgäu-Kempten — Kempten, Germany (Completed)
- Centro Cardiologico Monzino — Milan, Lombardy, Italy (Recruiting)
- Daugavpils Regional Hospital — Daugavpils, Latvia (Completed)
- 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie — Lublin, Poland (Recruiting)
- SUSCCH Banska Bystrica — Banská Bystrica, Slovakia (Completed)
- Lindenhofspital — Bern, Switzerland (Recruiting)
- Centre Hospitalier Universitaire Vaudois — Lausanne, Switzerland (Recruiting)
- Solothurner Spitäler AG — Olten, Switzerland (Recruiting)
Study contacts
- Principal investigator: Stefano Galli, MD — Centro Cardiologico Monzino
- Study coordinator: Marina Gattiglio, Dr.
- Email: marina.gattiglio@teleflex.com
- Phone: +41754295843
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.