Drug Eluting Pantera Lux Catheter Registry | NCT01081366

Studies
Drug Eluting Pantera Lux Catheter Registry

NCT01081366

Sponsor

Biotronik AG

Status

Completed

Last Update Posted

Jan 22, 2016Estimated

Enrollment

1,064Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Mar 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Mar 4, 2010

First Submission Date that Met QC Criteria

Mar 4, 2010

First Posted Date

Mar 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2016

Last Update Posted Date

Jan 22, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,064Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major Adverse Cardiac Events (MACE)	Death, non-fatal MI, clinically driven target vessel revascularization (TVR)	6 M

Secondary Outcomes

Measure	Description	Time Frame
MACE	Death, non-fatal MI, clinically driven TVR	12 M
All MACE	Death, non-fatal MI, any revascularization	1, 6, and12 M

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raph Toelg, MD	Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH, Am Kurpark 1, 23795 Bad Segeberg, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH		Bad Segeberg		23795	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24345357	Result	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.

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases