NCT01081366

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,064

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

1.9 years

First QC Date

March 4, 2010

Last Update Submit

January 21, 2016

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiac Events (MACE)

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

    6 M

Secondary Outcomes (4)

  • MACE

    12 M

  • All MACE

    1, 6, and12 M

  • Clinically driven TVR

    1, 6 and 12 M

  • Acute success

    Post procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Signed Patient Informed Consent / Data Release Form
  • Patient eligible for percutaneous coronary intervention (PCI)
  • Patient is older than 18 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24345357RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Raph Toelg, MD

    Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH, Am Kurpark 1, 23795 Bad Segeberg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2010

First Posted

March 5, 2010

Study Start

April 1, 2010

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

January 22, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)