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Trevisio Post-Approval Study
trial testing Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder in PFO - Patent Foramen Ovale in 254 participants. Completed in 4 January 2023.
| Lead sponsor | Abbott Medical Devices |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 254 |
| Start date | 14 September 2020 |
| Primary completion | 4 January 2023 |
| Estimated completion | 4 January 2023 |
| Sites | 22 locations across France, Italy, Netherlands, Germany, Poland, Switzerland, Spain |
Abbott Medical Devices — full company profile →
Eligibility, any sex, with PFO - Patent Foramen Ovale or ASD - Atrial Septal Defect. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Technical success, defined as successful deployment and release of at least one device
| Group | Value | 95% CI |
|---|---|---|
| ASD/PFO Cohort | 247 | |
| VSD Cohort | 3 |
The primary safety endpoint is device- or procedure-related serious adverse events through discharge or 7 days, whichever is earlier, including: * Cardiac perforation * Sustained atrial fibrillation requiring intervention * Device thrombus * Device erosion * Device embolization * Vascular complication requiring surgical intervention * Device- or procedure-related serious adverse event leading to death
| Group | Value | 95% CI |
|---|---|---|
| ASD/ PFO Cohort | 1 | |
| VSD Cohort | 0 |
Time frame: Pre-hospital discharge or 7 days after the procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | ASD/PFO Cohort | VSD Cohort |
|---|---|---|---|
| Device embolization | Vascular disorders | — | — |
| Reaction | System | ASD/PFO Cohort | VSD Cohort |
|---|---|---|---|
| Chest Pain | General disorders | — | — |
| Tachycardia | Cardiac disorders | — | — |
| Pain In The Punctured Groin | General disorders | — | — |
| Vasc Bleeding | General disorders | — | — |
| Other Skin Changes | Injury, poisoning and procedural complications | — | — |
| Oxygen Saturation Decrease | Investigations | — | — |
| St Segment Changes | Investigations | — | — |
| Headache | Nervous system disorders | — | — |
| Sore Throat | Respiratory, thoracic and mediastinal disorders | — | — |
| Hematoma | Vascular disorders | — | — |
| Hemolysis | Blood and lymphatic system disorders | — | — |
Most-reported serious reactions: Device embolization.
Data from ClinicalTrials.gov NCT04433520 adverse events section.
A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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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/NCT04433520.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing