Multicenter Pivotal Trial of the Minima Stent for Vascular Stenosis in Infants and Young Children
Authors' conclusion
The Minima system is safe and effective for treating PAS and CoA in infants and small pediatric patients. Luminal patency was preserved, and planned reinterventions for somatic growth seem well-tolerated in early follow-up.
Study context
- Population
- Infants and young children with pulmonary artery stenosis (PAS) or coarctation of the aorta (CoA) (recurrent or native)21 PAS, 15 recurrent CoA, 6 native CoA
- Participants
- 42 infants
- Outcome
- Stenosis relief; freedom from device-related serious adverse events or surgical intervention; maintenance of vessel lumen diameter on CT or catheter angiography
- Follow-up
- 6 months
Methodological detailsmulticentre, nonrandomised, pivotal
- Multicentre
- Nonrandomised
- Pivotal
Main finding
As reported in the abstract
- Successful implantation
- 41 (97.6%)
- Median increase in minimal vessel diameter
- 131% (46%-483%)
- Median pressure gradient in CoA, before vs after (mm Hg)
- 25 (0-63) to 0 (0-6; P<0.001)
- Explants or device-related serious adverse events at 6 months
- 0
- Luminal diameter maintained, % of implant diameter
- 89% (59%-137%)
Observational data: associations, not effects.
Further findings
Planned stent expansion · median follow-up 596 (412-979) days
- Planned stent expansion without complications
- 13 (31%; 7 CoA and 6 PAS)
Safety
Acute PAS stent embolization
- Acute PAS stent embolizations (both secured in contralateral PA; one treated with additional stent)
- 2
Transient femoral artery thrombosis (CoA, all under 6 kg)
- Patients with transient femoral artery thrombosis
- 7
Original publication
Multicenter Pivotal Trial of the Minima Stent for Vascular Stenosis in Infants and Young Children. Circ Cardiovasc Interv. Published 10 October 2025. doi:10.
Summarised from the published abstract; every number is checked against it