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

Coronary Artery Disease Clinical Trial

— PaneLux PTCA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01930903
• Other study ID #: 201202
• Status: Active, not recruiting
• Phase: N/A
• First received: August 26, 2013
• Last updated: April 29, 2015
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2014
• Source: Biotronik France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• High Bleeding Risk Patients
• Myocardial Ischemia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Chu Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Biotronik France	MedPass International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Target Lesion Failure		1 and 6 months	Yes
Secondary	Bleeding rate according to BARC definition		1, 6 and 12 months	Yes
Secondary	Clinically driven target vessel revascularization		1, 6 and 12 months	Yes
Secondary	MACCE	Cardiac death, stroke, myocardial infarction (Q wave and non Q wave) and TVR by non planned angioplasty or bypass graft	1, 6 and 12 months	Yes
Secondary	All deaths		1, 6 and 12 months	Yes
Secondary	Myocardial Infarction (MI) (Q wave and non Q wave)		1, 6 and 12 months	Yes
Secondary	Definite incidence of stent thrombosis		1, 6 and 12 months	Yes
Secondary	Clinically driven target lesion revascularization		1, 6 and 12 months	Yes
Secondary	Target lesion failure for patients >/= 80 years		1, 6 and 12 months	Yes
Secondary	Bleeding rate according to BARC definition for patients >/= 80 years		1, 6 and 12 months	Yes
Secondary	Target lesion failure for kidney failure patients (clearance < 30 ml/ min)		1, 6 and 12 months	Yes
Secondary	Bleeding Rate according to BARC definition for kidney failure patients (clearance < 30 ml/ min)		1, 6 and 12 months	Yes