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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease High Bleeding Risk Patients

Keywords

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PRO-Kinetic Energy BMS + Pantera Lux DEB combination

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Interventions

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Pantera Lux Drug Eluting Balloon

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject has provided a written informed consent
2. Subject \>/= 18 years.
3. Patient affiliated to social security
4. Patient acceptable candidate who accept to be contacted at different terms of clinical follow up (1, 6 and 12 months)
5. 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
6. Subject eligible for Dual Anti Platelet Therapy (DAPT) of acetyl salicylic acid and clopidogrel for at least 3 weeks
7. De Novo coronary lesions: \>/= 50% - \<100%
8. Subject, vessels and target lesion eligible for angioplasty with PRO-Kinetic Energy stent implantation and final post-dilatation with Pantera Lux drug eluting balloon.
9. Target lesion length \</= 26 mm , visual estimation or by Quantitative Coronary Angiography (QCA)
10. Reference diameters targeted vessels \>/=2.5mm and \</= 4.0 mm (visual estimation or QCA)

Exclusion Criteria

1. Pregnant or breast feeding females or females who intend to become pregnant during the time of the study
2. Subject with a life expectancy less than 1 year
3. Vulnerable subject, protected by law, unable to give his/her consent
4. Subject currently enrolled in other medical or drug study and has not reached the primary outcome measures of that study
5. Subject unable to be contacted for the clinical follow up at 1, 6 and 12 months
6. Subject under chronical oral anti-coagulant treatment (optionnal indication)
7. 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
8. In stent restenotic lesion
9. Target lesion on vessels with nominal diameter \< 2.5 mm
10. Target lesion is located in or supplied by an arterial or venous bypass graft
11. Chronical Total occlusion (CTO)
12. Angioplasty indication for STEMI
13. Patient with signs of cardiogenic shock
14. Angioplasty antecedent with stent implantation (before 12 months for DES, before 6 months for BMS)
15. "Staged procedure" \> 8 days after the initial angioplasty
16. Documented left ventricular ejection fraction (LVEF) \</= 30%
17. 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…)
18. Known allergies to acetylsalicylic acid, active agent such Paclitaxel, Expicients like BHTC (Butiriltri-n-hexyl citrate), CoCr, Silicon Carbide.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jérôme Roncalli, Prof

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Chu Toulouse

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED

PMID: 30927531 (View on PubMed)

Other Identifiers

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201202

Identifier Type: -

Identifier Source: org_study_id