With this commitment, we are dedicated to developing clinical studies based on ethical and scientific principles and in accordance with the National and International Standards and Regulations applied to Clinical Research.
Additionally, we recognize the importance of transparently presenting the clinical research that is conducted with our devices. Thus, our studies are registered on official public research platforms such as ClinicalTrials.gov.
| Clinical Trial | Study Design | Follow-up | Sample(N) | Publication | Status |
|---|---|---|---|---|---|
| Inspiron I | Multicenter, prospective, randomized study to evaluate safety and efficacy of Inspiron Sirolimus Eluting Stent (NCT01093391) | 4 years | 57 (60 lesions) | LINK | Completed / Published |
| Destiny Trial | Multicenter, prospective, randomized study to show non-inferiority of Inspiron Sirolimus Eluting Stent against Biolimus Eluting Stent (NCT01856088) | 5 years | 170 | LINK LINK LINK |
Completed / Published |
| Inspiron Real Life Registry I | Investigator initiated, prospective, non-randomized study to demonstrate the performance of Inspiron Sirolimus Eluting Stent in complex population | 3 years | 470 | LINK | Completed / Published |
| Inspiron Real Life Registry II | Multicenter, prospective, non-randomized registry to demonstrate the performance of Inspiron Sirolimus Eluting Stent in real-world population (NCT03263260) | 2 years | 2504 | LINK | Completed |
| Inspiron Repair | Multicenter, prospective, randomized study to evaluate the tissue coverage after Inspiron Sirolimus Eluting Stent implantation at 1, 2 and 3 months (NCT03269461) | 2 years | 60 | LINK | Completed / Published |
| Inspiron All-commers | Prospective, non-randomized, single center study to evaluate clinical outcomes after Inspiron stent implantation | 12 months | 790 | LINK | Completed / Published |
| Latitude Registry | Multicenter, prospective, non-randomized registry to demonstrate the performance of Inspiron Sirolimus Eluting Stent in real-world population (NCT03471234) | 2 years | 299 | LINK | Completed |
| Cardiology Institute Inspiron Registry (Porto Alegre/RS) | Prospective registry to compare an ultra-thin sirolimus-eluting stent (Inspiron®) with other third-generation drug-eluting stent platforms | 2 years | 709 | LINK | On going |
| Embosoft I | Multicenter, prospective, non-randomized study to evaluate the uterine volume reduction and quality of life improvement after Uterine Artery Embolization for leyomioma treatment (NCT03535610) | 6 months | 32 | LINK | Completed / Published |
| PoPAE Study | Randomized, open and controlled study for a comparative analysis of prostate hyperplasia treatment: prostatic artery embolization vs. open prostatectomy (UTN: U1111-1250-6616) | 12 months | 48 | LINK | Completed / Published |
| Benign Prostatic Hyperplasia Case report (Embosoft) | Case Report of Transradial Prostatic Artery Embolization as a Salvage Procedure in a Patient With Severe Deformities and Refractory Hematuria of Prostatic Origin | 3 months | 1 | LINK | Completed / Published |
| SOLARIS Peripheral PMCF Trial | Physician-Initiated PMCF Trial Investigating the Solaris Vascular Stent Graft for the treatment of iliac lesions – SOLARIS Peripheral PMCF Trial (NCT04299906) | 1 year | 70 | LINK | On going |
| Solaris in FAV/AVG | Retrospective analysis of patients treated for hemodialysis vascular access outflow stenosis with Solaris stents | 6 months | 114 | LINK | Completed / Published |
| Solaris in BS-CERAB | Retrospective cohort study of patients who underwent endovascular treatment for severe steno-occlusive atherosclerotic aorto-iliac lesions (NCT06012123) | 1 year | 42 | LINK | Completed / Published |
| Aneurism Case Report (Solaris) | Case report of an endovascular treatment in an isolated aneurysm of the deep femoral artery | 1 year | 1 | LINK | Completed / Published |
| Pseudoaneurysm Case Report (Solaris) | Case report of an endovascular treatment of venous bypass graft pseudoaneurysm | 1 month | 1 | LINK | Completed / Published |
| Sleeve Gastrectomy (ALTUS) | Observational study to monitor the progress of weight loss and control of comorbidities in patients undergoing vertical gastrectomy with duodenal bipartition | 6 months | 5 | LINK | Completed / Published |
| ALTUS Study | Observational study to evaluate the safety and performance of the Altus Stapler during use in bariatric surgery (NCT05642663) | 1 year | 300 | LINK | On going |
