Last reviewed · How we verify
NCT05531578
Transfemoral Implant of Inovare® Transcatheter Valve
NA trial testing INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper) in Aortic Valve Stenosis in 60 participants. Participants enrolled and being followed up; not accepting new ones.
20 February 2024
Quick facts
| Lead sponsor | Braile Biomedica Ind. Com. e Repr. Ltda. |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 11 September 2020 |
| Primary completion | 20 February 2024 |
| Estimated completion | 30 December 2028 |
| Sites | 4 locations across Brazil |
Drugs / interventions tested
- INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)
Conditions studied
- Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
Sponsor
Braile Biomedica Ind. Com. e Repr. Ltda.
Who can join
18 and older, any sex, with Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Insights into calcific aortic valve stenosis: a comprehensive overview of the disease and advancing treatment strategies
Jain H, Goyal A, Khan A, Khan N, et al · · 2024
Verify or expand the search:
- PubMed search for NCT05531578
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Aortic Valve Stenosis
Currently open trials in the same condition.
- NCT07455292 — Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging · NA · recruiting
- NCT07008911 — CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation · NA · recruiting
- NCT07145463 — Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the VitaFlow Liberty® Flex Transcatheter Aorti · NA · recruiting
- NCT07520656 — Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing · recruiting
- NCT07267117 — Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease · recruiting
Other Braile Biomedica Ind. Com. e Repr. Ltda. trials
Trials by the same sponsor.
- NCT06959836 — Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve · completed
- NCT06270537 — Post-market Clinical Trial of the Dominus® Stent-Graft · recruiting
- NCT05902897 — Aortic or Mitral Valve Replacement With the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05531578 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Braile Biomedica Ind. Com. e Repr. Ltda.
- Last refreshed: 11 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05531578.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing