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A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.
Clinical follow-up visits will take place at 1, 6, and 12 months and annually thereafter until 60 months post procedure.
All subjects will undergo an angiographic follow-up at 6- and 12-month follow up.
IVUS, (including IVUS-VH documentation) and OCT will be performed for all subjects at 6-month and 12-month follow-up (if the safety of the subject allows it and as per the investigator's decision).
Vasomotion will be assessed angiographically with Acetylcholine followed by Nitroglycerine at 12 months follow up in a subgroup of subjects, upon the investigators discretion and if subject consents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | All subjects will be implanted with the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) and followed up until 60 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold | Device | Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold |
| Measure | Description | Time Frame |
|---|---|---|
| In scaffold late lumen loss | Independent Core Lab Assessment | At 6 months after index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Haude, Prof | Rheinland Klinikum Lukaskrankenhaus Neuss | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Graz | Graz | Austria | ||||
| Algemeen Ziekenhuis Middelheim |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40091374 | Derived | Aytekin A, Seguchi M, Xhepa E, Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Garcia-Garcia HM, Waksman R, Joner M. The Impact of Underlying Plaque Characteristics Following the Third-Generation Resorbable Magnesium Scaffold Implantation: An Intravascular OCT Assessment up to 12-Months. Catheter Cardiovasc Interv. 2025 Jun;105(7):1563-1571. doi: 10.1002/ccd.31486. Epub 2025 Mar 16. | |
| 37334655 |
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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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| Antwerp |
| Belgium |
| Ziekenhuis Oost-Limburg | Genk | Belgium |
| UZ Leuven Gasthuisberg | Leuven | Belgium |
| Segeberger Kliniken | Bad Segeberg | Germany |
| Herz-und Gefäßzentrum Oberallgäu-Kempten | Kempten | Germany |
| Johannes Wesling Klinikum Minden | Minden | Germany |
| Deutsches Herzzentrum | Münich | Germany |
| Rheinland Klinikum Lukaskrankenhaus Neuss | Neuss | Germany |
| Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG) | Amsterdam | Netherlands |
| Miedziowe Centrum Zdrowia SA | Lubin | Poland |
| Hospital Clinico San Carlos | Madrid | Spain |
| Lund University Hospital | Lund | Sweden |
| University Hospital Geneva HUG | Geneva | Switzerland |
| Derived |
| Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Ferdinande B, Escaned J, Iglesias JF, Bennett J, Toth GG, Joner M, Toelg R, Wiemer M, Olivecrano G, Vermeersch P, Garcia-Garcia HM, Waksman R. A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study. EuroIntervention. 2023 Aug 7;19(5):e414-e422. doi: 10.4244/EIJ-D-23-00326. |
| 37113674 | Derived | Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Ferdinande B, Escaned J, Iglesias JF, Bennett J, Toth G, Joner M, Toelg R, Wiemer M, Olivecrona G, Vermeersch P, Garcia-Garcia HM, Waksman R. Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study. EClinicalMedicine. 2023 Apr 17;59:101940. doi: 10.1016/j.eclinm.2023.101940. eCollection 2023 May. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |