Overall Mortality
Conditions
Brief summary
The aim is to collect long-term clinical data from 132 patients from Belgium, Germany and Austria who had previously participated in either of the BIOLUX P-I or P-II studies. Patients in these studies were treated with either a percutaneous transluminal angioplasty (PTA) balloon catheter or a drug-coated Passe-18-Lux balloon (DCB). The purpose of Retro-BIOLUX P-I-II is to collect clinical data from patients treated with either Passeo-18 PTA or Passeo-18 Lux DCB to analyze the long-term effects.
Interventions
DEVICEPasseo-18
POBA
DEVICEPasseo-18 Lux
DCB
Sponsors
Biotronik AG
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Subject was previously enrolled in either BIOLUX P-I or BIOLUX P-II 2. Subject was treated either with Passeo-18 PTA or Passeo-18 LUX 3. Written informed consent by subject or subject's legal representative or impartial witness/waiver
Exclusion criteria
1. Subject did neither participate in BIOLUX P-I nor BIOLUX P-II 2. Subject was neither treated with Passeo-18 Lux nor with Passeo-18 PTA 3. Subject is not willing to sign an informed consent /data release form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 60 months | Overall survival at five years after index procedure, defined as death from any cause |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, defined as the time in days after index procedure to date of death from any cause. | 60 months |
| Major amputations of target extremities | 60 months |
| Clinically-driven target lesion revascularization | 60 months |
| Cause of death (descriptive analysis) at five years after treatment within BIOLUX P-I/-II. | 60 months |
Countries
Austria, Belgium, Germany
Outcome results
None listed