Table 3.
Clinical trials of Mg-based stents
| Trial name | Stent/Alloy | Number of subjects | Symptoms | Summarized outcomes | Authors and references |
|---|---|---|---|---|---|
| – | AMS (WE43) | 20 (M10, F10) | Critical limb ischemia | One patient died; primary clinical patency 89.5% | Peeters et al.[27] |
| AMS INSIGHT | AMS (WE43) | 117 | Critical limb ischemia; de novo stenotic or occlusive atherosclerotic disease | Within 30 days, the amputation or death rate was 5.3% vs 5.0% in control group; the 6-month angiographic patency rate was 31.8% vs 58% in control group; no efficacy in the long-term patency compared to percutaneous transluminal angioplasty (PTA) | Bosiers and Investigators[28] |
| – | AMS (WE43) | 1 female preterm baby | Ligation of the left pulmonary artery | On 7th day, reperfusion of the left lung as complete as vascular system allowed and thrombus distal to the stent was dissolved; after 6 weeks, the patient was extubated; 5 months later, the left lung perfusion persisted with a slight difference in size between left and right pulmonary artery | Zartner et al.[29] |
| – | AMS (WE43) | A three-week-old male baby | Critical aortic coarctation | At the age of 3 months, ventricular septal defect (VSD) closure had to be performed because of left to right shunting | Schranz et al.[30] |
| – | Magic stent (WE43) | A two-month old girl | Pulmonary atresia, VSD, and multiple aortopulmonary collaterals with severely hypoplastic pulmonary arteries | Initial significant increase in vessel diameter at first, but significant restenosis occurred at 4 months | McMahon et al.[31] |
| PROGRESS-AMS | AMS (WE43) | 63 (M 44, F19) | Ischemic heart disease or silent ischemia and a discrete de novo lesion in coronary artery | Diameter stenosis reduced from 61.5% ± 13.1% to 12.6 ± 5.6%; in segment acute gain of 1.41 ± 0.46 mm and late loss of 1.08 ± 0.49 mm; 4 months later, ischemia-driven target lesion revascularization rate was 23.8%, the overall target lesion revascularization rate was 45% after 1 year | Erbel et al.[3] |
| BIOSOLVE-I | Drug-eluting absorbable metal scaffold (DREAMS, WE43) | 46 | – | 2 patients had target lesion failure after 6 months, and at 12 months another patient had same problem; overall target lesion revascularization was 26.7% after 12 months; at 6 months and 12 months, the lumen loss were reduced (0.65 ± 0.50 mm and 0.52 ± 0.39 mm, respectively) compared to 1.08 ± 0.49 mm at 4 months of PROGRESS trial | Haude et al.[4] |
Note: M = Male, F = Female.