Trials / Unknown
UnknownNCT04591938
FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo CAD: the ENCORE-I Study
Safety and Efficacy of the FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo Coronary Artery Disease: the ENCORE-I Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Joost Daemen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, multicentre, non-randomized, investigator-initiated study aiming to assess the safety and efficacy of the Fantom Encore sirolimus-eluting bioresorbable scaffold (BRS).
Detailed description
Up to 50 consecutive participants with de-novo non-complex obstructive coronary lesions and non-ST elevation acute coronay syndromes or stable angina pectoris will be included in the Netherlands and Belgium. Device performance and behaviour will be assessed by angiography and optical coherence tomography at the index procedure and at 13 months follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Fantom Encore Bioresorbable scaffold implantation | Fantom Encore Bioresorbable scaffold implantation |
Timeline
- Start date
- 2019-10-01
- Primary completion
- 2021-06-01
- Completion
- 2025-12-31
- First posted
- 2020-10-19
- Last updated
- 2020-10-19
Locations
3 sites across 2 countries: Belgium, Netherlands
Source: ClinicalTrials.gov record NCT04591938. Inclusion in this directory is not an endorsement.