Drug Eluting Pantera Lux Catheter Registry

Biotronik AG1,064 enrolled

Overview

All comers registry - Evaluation of the safety and efficacy of the Pantera Lux Paclitaxel releasing balloon for coronary arteries in daily clinical practice.

All patients are treated with the Pantera Lux Paclitaxel releasing balloon. Clinical follow ups at 1, 6 and 12 months after coronary intervention.

Study Type

OBSERVATIONAL

Enrollment

1,064

Conditions

Coronary Artery Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH

Bad Segeberg, Germany

Outcomes

Primary Outcomes

Major Adverse Cardiac Events (MACE)

Death, non-fatal MI, clinically driven target vessel revascularization (TVR)

Time frame: 6 M

Secondary Outcomes

MACE

Death, non-fatal MI, clinically driven TVR

Time frame: 12 M

All MACE

Death, non-fatal MI, any revascularization

Time frame: 1, 6, and12 M

Clinically driven TVR

Time frame: 1, 6 and 12 M

Acute success

Clinical device success, clinical procedure success

Time frame: Post procedure

Data from ClinicalTrials.gov

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