Trials / Terminated
TerminatedNCT03600948
BIOFLOW-SV All Comers Registry
BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the SiroLimus Eluting Orsiro Stent Within Daily Clinical Practice in Small Vessels
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 261 (actual)
- Sponsor
- Biotronik AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Assessment of the clinical safety and performance of the Orsiro drug-eluting stent in a real world setting in patients with small vessels with reference vessel diameter ≤2.75 mm.
Detailed description
Prospective, single-arm, multi-center, all-comers registry with clinical follow-up visits at the hospital or by phone at 6 and 12 months post-procedure. A minimum of 1000 patients will be enrolled in approximately 15 sites in Brazil, including at least 415 patients with reference vessel diameter ≤2.75 mm as assessed by online QCA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Orsiro Sirolimus Eluting Coronary Stent System | Percutaneous coronary intervention |
Timeline
- Start date
- 2018-08-27
- Primary completion
- 2020-08-31
- Completion
- 2021-10-06
- First posted
- 2018-07-26
- Last updated
- 2024-02-15
Locations
2 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03600948. Inclusion in this directory is not an endorsement.