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OpenTrials
Completed

NCT Number: NCT01081366

Drug Eluting Pantera Lux Catheter Registry

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

About this study

All patients are treated with the Pantera Lux Paclitaxel releasing balloon.

Clinical follow ups at 1, 6 and 12 months after coronary intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Major Adverse Cardiac Events (MACE)

    Time frame: 6 M

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

Secondary outcomes

  1. MACE

    Time frame: 12 M

    Death, non-fatal MI, clinically driven TVR

  2. All MACE

    Time frame: 1, 6, and12 M

    Death, non-fatal MI, any revascularization

  3. Clinically driven TVR

    Time frame: 1, 6 and 12 M

  4. Acute success

    Time frame: Post procedure

    Clinical device success, clinical procedure success

Sponsors and collaborators

Lead sponsor

Biotronik AG

Industry

Registry information

Official study title

Evaluation of the Safety Profile of the Pantera Lux Paclitaxel Releasing Balloon for Coronary Arteries in Daily Clinical Practice

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 5, 2010
Registry last updated
Jan 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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