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CompletedNCT01081366Updated Jan 22, 2016

Drug Eluting Pantera Lux Catheter Registry

An observational study in Coronary Artery Disease, sponsored by Biotronik AG. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-22.

Sponsored by Biotronik AG · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,064
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 1,064 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Biotronik AG is the lead sponsor of 39 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All comers registry. Patients treated with the Pantera Lux Paclitaxel releasing balloon catheter are enrolled consecutively to represent a typical set of patients at each site.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,064 participants (actual)
06

What researchers measure

Primary outcomes

  1. Major Adverse Cardiac Events (MACE)

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

    Time frame: 6 M

Secondary outcomes

  1. MACE

    Death, non-fatal MI, clinically driven TVR

    Time frame: 12 M

  2. All MACE

    Death, non-fatal MI, any revascularization

    Time frame: 1, 6, and12 M

  3. Clinically driven TVR

    Time frame: 1, 6 and 12 M

  4. Acute success

    Clinical device success, clinical procedure success

    Time frame: Post procedure

07

Study locations

1 site
  • Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH
    Bad Segeberg, 23795, Germany
08

References and documents

Publications

  • Toelg R, Merkely B, Erglis A, Hoffman S, Bruno H, Kornowski R, Slagboom T, Naber C, Witzenbichler B, Graf K, Richardt G, Hehrlein C; DELUX investigators. Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: clinical results of the international real-world DELUX registry. EuroIntervention. 2014 Sep;10(5):591-9. doi: 10.4244/EIJV10I5A102. PubMed 24345357 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01081366
Lead sponsor
Biotronik AG
Responsible party
Sponsor
First posted
Mar 5, 2010
Start date
Apr 2010
Primary completion
Mar 2012
Completion
May 2012
Last update
Jan 22, 2016

Study contacts

Raph Toelg, MD
principal investigator · Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH, Am Kurpark 1, 23795 Bad Segeberg, Germany

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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