Status: Not yet recruiting
The Ladera Suture-Mediated Large Bore Closure Pivotal Study
The study objective is to demonstrate the safety and efficacy of the investigational device to achieve hemostasis of common femoral artery access sites in participants undergoing percutaneous interventional catheterization procedures utilizing 10 to 24 Fr introducer sheaths.
Participants needed: 214
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Ladera MedicalUpdated: Apr 21, 2026Locations: 1
Eligibility criteria
Participant is ≥ 18 years old [+4]
Prior intra-aortic balloon pump at access site within 30 days of baseline evalua... [+45]