Trials / Recruiting
RecruitingNCT05617599
SUPRAFLEX CRUZ PMCF Study ( rEpic05 )
SUPRAFLEX CRUZPost-Market Clinical Follow-up Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 508 (estimated)
- Sponsor
- Fundación EPIC · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Medical Device Regulations (MDR) with multivessel coronary disease requirements in all the CONSECUTIVE patients treated with (SUPRAFLEX CRUZ).
Detailed description
The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the SUPRAFLEX CRUZ in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SUPRAFLEX CRUZ | Patients in whom treatment with SUPRAFLEX CRUZ has been attempted |
Timeline
- Start date
- 2023-05-10
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2022-11-15
- Last updated
- 2025-12-16
Locations
21 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT05617599. Inclusion in this directory is not an endorsement.