Overview

This trial is active, not recruiting.

Conditions coronary artery disease, high bleeding risk patients
Treatment pantera lux drug eluting balloon
Sponsor Biotronik France
Collaborator Biostatistics : Medpass International, 95 bis boulevard Pereire, 75017 Paris
Start date September 2013
End date December 2015
Trial size 500 participants
Trial identifier NCT01930903, 201202

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Primary purpose treatment

Primary Outcomes

Measure
Target Lesion Failure (TLF) at 12 months.
time frame: 12 months

Secondary Outcomes

Measure
Target Lesion Failure
time frame: 1 and 6 months
Bleeding rate according to BARC definition
time frame: 1, 6 and 12 months
Clinically driven target vessel revascularization
time frame: 1, 6 and 12 months
MACCE
time frame: 1, 6 and 12 months
All deaths
time frame: 1, 6 and 12 months
Myocardial Infarction (MI) (Q wave and non Q wave)
time frame: 1, 6 and 12 months
Definite incidence of stent thrombosis
time frame: 1, 6 and 12 months
Clinically driven target lesion revascularization
time frame: 1, 6 and 12 months
Target lesion failure for patients >/= 80 years
time frame: 1, 6 and 12 months
Bleeding rate according to BARC definition for patients >/= 80 years
time frame: 1, 6 and 12 months
Target lesion failure for kidney failure patients (clearance < 30 ml/ min)
time frame: 1, 6 and 12 months
Bleeding Rate according to BARC definition for kidney failure patients (clearance < 30 ml/ min)
time frame: 1, 6 and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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
  • Documented left ventricular ejection fraction (LVEF) </= 30%
  • Target lesion requiring before stent implantation a device other than a pre-dilatation balloon (including, but not only restricted to laser, cutting balloon, directional coronary atherectomy, rotational atherectomy etc…)
  • Known allergies to acetylsalicylic acid, active agent such Paclitaxel, Expicients like BHTC (Butiriltri-n-hexyl citrate), CoCr, Silicon Carbide.

Additional Information

Official title Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon
Principal investigator Jérôme Roncalli, Prof
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Biotronik France.