Drug Eluting Pantera Lux Catheter Registry

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081366
• Other study ID #: C0905 DELUX
• Status: Completed
• Phase: N/A
• First received: March 4, 2010
• Last updated: January 21, 2016
• Start date: April 2010
• Est. completion date: May 2012

Study information

• Verified date: January 2016
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionBelgium: Ethics CommitteeCanada: Ethics Review CommitteeFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéGermany: Ethics CommissionHungary: Institutional Ethics CommitteeIsrael: Ethics CommissionLatvia: Institutional Review BoardNetherlands: Independent Ethics CommitteeSpain: Ethics CommitteeSwitzerland: EthikkommissionUnited Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

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

Description:

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1064
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Germany	Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH	Bad Segeberg

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Country where clinical trial is conducted

Germany, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events (MACE)	Death, non-fatal MI, clinically driven target vessel revascularization (TVR)	6 M	Yes
Secondary	MACE	Death, non-fatal MI, clinically driven TVR	12 M	Yes
Secondary	All MACE	Death, non-fatal MI, any revascularization	1, 6, and12 M	Yes
Secondary	Clinically driven TVR		1, 6 and 12 M	Yes
Secondary	Acute success	Clinical device success, clinical procedure success	Post procedure	No