PaneLux PTCA : Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon

NCT01930903 | Unknown

• 1 other identifier: 201202
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug Eluting Balloon.

Conditions

Coronary Artery Disease; High Bleeding Risk Patients

Keywords

PRO-Kinetic Energy BMS + Pantera Lux DEB combination

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure (TLF) at 12 months.

  TLF is defined as a composite of cardiac death, any target vessel myocardial infarction (MI), urgent coronary artery bypass graft (CABG) and clinically driven target lesion revascularization (TLR).

  12 months

Secondary Outcomes (12)

• Target Lesion Failure

  1 and 6 months

• Bleeding rate according to BARC definition

  1, 6 and 12 months

• Clinically driven target vessel revascularization

  1, 6 and 12 months

• MACCE

  1, 6 and 12 months

• All deaths

  1, 6 and 12 months

Interventions

Pantera Lux Drug Eluting Balloon DEVICE

All patients are treated with the PRO-Kinetic Energy Stent and Pantera Lux drug eluting balloon for the last post dilatation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided a written informed consent
• Subject \>/= 18 years.
• Patient affiliated to social security
• Patient acceptable candidate who accept to be contacted at different terms of clinical follow up (1, 6 and 12 months)
• Subject eligible for percutaneous coronary intervention AND undergoing a chronical oral anticoagulant treatment OR undergoing any semi-urgent invasive or non cardiac surgical planned intervention with major bleeding risks
• Subject eligible for Dual Anti Platelet Therapy (DAPT) of acetyl salicylic acid and clopidogrel for at least 3 weeks
• De Novo coronary lesions: \>/= 50% - \<100%
• Subject, vessels and target lesion eligible for angioplasty with PRO-Kinetic Energy stent implantation and final post-dilatation with Pantera Lux drug eluting balloon.
• Target lesion length \</= 26 mm , visual estimation or by Quantitative Coronary Angiography (QCA)
• Reference diameters targeted vessels \>/=2.5mm and \</= 4.0 mm (visual estimation or QCA)

You may not qualify if:

• Pregnant or breast feeding females or females who intend to become pregnant during the time of the study
• Subject with a life expectancy less than 1 year
• Vulnerable subject, protected by law, unable to give his/her consent
• Subject currently enrolled in other medical or drug study and has not reached the primary outcome measures of that study
• Subject unable to be contacted for the clinical follow up at 1, 6 and 12 months
• Subject under chronical oral anti-coagulant treatment (optionnal indication)
• Subject undergoing any urgent invasive or surgical intervention with major bleeding risk, which can not maintain dual anti-platelet therapy (DAPT) for at least 3 weeks
• In stent restenotic lesion
• Target lesion on vessels with nominal diameter \< 2.5 mm
• Target lesion is located in or supplied by an arterial or venous bypass graft
• Chronical Total occlusion (CTO)
• Angioplasty indication for STEMI
• Patient with signs of cardiogenic shock
• Angioplasty antecedent with stent implantation (before 12 months for DES, before 6 months for BMS)
• "Staged procedure" \> 8 days after the initial angioplasty

Sponsors & Collaborators

• Biotronik France: lead
• MedPass International: collaborator

Study Sites (1)

Chu Toulouse

Toulouse, France

Location

Related Publications (1)

• Roncalli J, Godin M, Boughalem K, Shayne J, Piot C, Huret B, Belle L, Cayla G, Faurie B, Amor M, Karsenty B, Leclercq F. Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial). J Invasive Cardiol. 2019 Apr;31(4):94-100. doi: 10.25270/jic/18.00272.

  PMID: 30927531 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Jérôme Roncalli, Prof

  CHU Toulouse, Hôpital Rangueil, TSA 50032, 31059 TOULOUSE Cedex 9

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: August 29, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 30, 2015

Record last verified: 2014-02

Locations

FR (1)