Coronary Artery Disease
Conditions
Brief summary
All comers registry - Evaluation of the safety and efficacy of the Pantera Lux Paclitaxel releasing balloon for coronary arteries in daily clinical practice.
Detailed description
All patients are treated with the Pantera Lux Paclitaxel releasing balloon. Clinical follow ups at 1, 6 and 12 months after coronary intervention.
Interventions
None listed
Sponsors
Biotronik AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed Patient Informed Consent / Data Release Form * Patient eligible for percutaneous coronary intervention (PCI) * Patient is older than 18 years of age
Exclusion criteria
* Patient has a known allergy against appropriate anticoagulation / antiplatelet therapy * Patients with known allergy against paclitaxel or BTHC * Patients with a target lesion that was previously treated by brachytherapy * Pregnant woman or lactating woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events (MACE) | 6 M | Death, non-fatal MI, clinically driven target vessel revascularization (TVR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 12 M | Death, non-fatal MI, clinically driven TVR |
| All MACE | 1, 6, and12 M | Death, non-fatal MI, any revascularization |
| Clinically driven TVR | 1, 6 and 12 M | — |
| Acute success | Post procedure | Clinical device success, clinical procedure success |
Countries
Germany
Outcome results
None listed