Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis.

Coronary Artery Disease Clinical Trial

— BIOLUX-RCT  

Official title:

BIOLUX RCT - Clinical Performance of the Pantera LUX Paclitaxel Releasing Balloon Versus the Drug Eluting Orsiro Hybrid Stent System in Patients With In-stent Restenosis - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651390
• Other study ID #: C1105
• Status: Completed
• Phase: N/A
• First received: July 24, 2012
• Last updated: September 23, 2016
• Start date: June 2012
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesGermany: Federal Office for Radiation ProtectionLatvia: Institutional Review BoardLatvia: State Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

To determine in a randomized controlled trial (RCT) whether percutaneous coronary intervention - in patients with in-stent restenosis in either bare metal stents or drug eluting stents - with the Pantera Lux balloon is angiographically non-inferior to percutaneous intervention with the Orsiro stent 6 months post-procedure.

Description:

This clinical investigation is an international, multi-center, randomized controlled trial with angiographic follow up at 6 months. Clinical follow ups will take place at 6, 12 and 18 months.

Up to 210 subjects will be block randomized 2:1 to receive the Pantera Lux balloon or the Orsiro stent and will be stratified according to diabetic status at screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: July 2016
• Est. primary completion date: January 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. Clinical evidence of ischemic heart disease and/or a positive functional study, stable or unstable angina pectoris or documented silent ischemia

4. Subject eligible for percutaneous coronary intervention

5. Subject acceptable candidate for coronary artery bypass surgery

6. Subject with an in-stent restenotic lesion* in either a bare metal stent or drug eluting stents (Mehran class I, II, III, IV - Mehran et al. Circulation 199; 100: 1872-1878). *Target lesion

7. Subjects with a maximum of 2 target lesions. In case of 2 target lesions, both lesions must be either in bare metal stents or drug eluting stents, and must treated during the same session with the same type of device as per randomization outcome, e.g. drug eluting stent.

8. Target reference vessel diameter (visual estimation): = 2.0 and = 4.0 mm

9. Target lesion length (visual estimation): = 6.0 and = 28.0 mm

10. Target lesion stenosis (visual estimation): > 50 % and = 100 %

11. Target lesion in a native coronary artery

Exclusion Criteria:

1. Planned (staged) interventional treatment in the same vessel(s) as the target lesion(s) within 30 days pre- and/or post BIOLUX RCT index procedure.

2. Evidence of acute ST-segment-elevation myocardial infarction within 48 hours prior to index procedure according to the universal definition of myocardial infarction

3. Subjects with acute cardiac decompensation or acute cardiogenic shock

4. Subject with a life expectancy of less than 18 month

5. In the investigators opinion subject who will not be able to comply with the follow up requirements

6. Impaired renal function (excluded are subjects in need of dialysis or subjects with a creatinine level = 221 µmol per liter (2.5 mg per deciliter) within 72 hours of the intended treatment)

7. Thrombus in the target vessel

8. Target lesion located in left main coronary artery

9. Documented left ventricular ejection fraction (LVEF) = 30%

10. Known allergies to: acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparin, contrast medium, sirolimus or similar drugs (i.e., ABT 578, biolimus, tacrolimus); CoCr, PLLA, silicon carbide

11. Subject is receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)

12. Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached

13. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study

14. Previously enrolled in this trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Myocardial Ischemia

Intervention

Device:
• Percutaneous coronary intervention
Up to 140 patients meeting the inclusion criteria and none of the exclusion criteria are randomly selected and stratified according to diabetic status at screening are treated with the Pantera Lux drug coated balloon.
• Percutaneous coronary intervention
Up to 70 patients meeting the inclusion criteria and none of the exclusion criteria are randomly selected and stratified according to diabetic status at screening are treated with the Orsiro drug eluting stent.

Locations

Country	Name	City	State
Germany	Universitäts-Herzzentrum Freiburg-Bad Krozingen	Bad Krozingen
Germany	Heart Center Segeberger Kliniken	Bad Segeberg
Germany	Charité - Universitätsmedizin Berlin, Charité Centrum 11 für Herz-, Kreislauf- und Gefäßmedizin	Berlin
Germany	Innere Medizin Kardiologie - Charité Centrum 11, Campus Benjamin Franklin	Berlin
Germany	Kardiologie - Angiologie - Pneumologie, Klinikum Coburg	Coburg
Germany	Contilia Heart- and Vascular Center, Elisabeth Krankenhaus	Essen
Germany	Medical Care Center Prof. Mathey, Prof. Schofer	Hamburg
Germany	Kardiologie /Intern. Intensivmedizin, Johannes Wesling Klinikum Minden	Minden
Germany	Klinikum Bogenhausen	Munich
Germany	Klinikum Schwabing	Munich
Germany	LMU - Klinikum der Universität München	Munich
Germany	Universitätsklinikum Münster, Klinik für Kardiologie	Münster
Germany	Innere Medizin III Kardiologie, Kliniken Villingen	Villingen-Schwenningen
Latvia	Cardiology, Pauls Stradins Clinical University Hospital	Riga

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Germany,  Latvia, 

References & Publications (2)

Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. — View Citation

Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, Satler LF, Pichard AD, Kent KM, Stone GW, Leon MB. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation. 1999 Nov 2;100(18):1872-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late lumen loss (in-stent)	In-stent late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).; In-stent: Pantera Lux balloon: In-stent is defined as from (proximal) shoulder to (distal) shoulder of the dilated balloon.; Orsiro stent: In-stent is defined as from (proximal) edge to (distal) edge of the implanted Orsiro stent.	After 6 months.	No
Secondary	Percent diameter stenosis in-stent and in-segment	Percent diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%. Angiographic parameters as evaluated by offline QCA.; In-segment: Pantera Lux balloon: In-segment is defined as in-stent plus 5 mm distal and 5 mm proximal.; Orsiro stent: In-segment is defined as in-stent plus 5 mm distal and 5 mm proximal.	After 6 months.	No
Secondary	Binary restenosis in-stent and in-segment	Binary restenosis is defined as =50% lumen diameter stenosis as evaluated by offline QCA.	After 6 months.	No
Secondary	Mean lumen diameter in-stent and in-segment	Mean minimum lumen diameter derived from two orthogonal views as evaluated by offline QCA.	After 6 months.	No
Secondary	Type of reoccurrence according to Mehran classification	Type of reoccurrence according to Mehran classification (Mehran et al. Circulation 199; 100: 1872-1878) evaluated by offline QCA.	After 6, 12 and 18 months.	No
Secondary	Target lesion failure (TLF)	TLF is defined as a composite of cardiac death, any target vessel myocardial infarction (MI), coronary artery bypass graft (CABG) and clinically driven target lesion revascularization (TLR).	After 6 and 18 months.	Yes
Secondary	Target vessel failure (TVF)	TVF is defined as a composite of cardiac death, any target vessel myocardial infarction, coronary artery bypass graft and clinically driven target vessel revascularization (TVR).	After 6, 12 and 18 months.	Yes
Secondary	Stent thrombosis	According to Academic Research Consortium (ARC) definition (Cutlip et al. Circulation 2007; 115: 2344-2351).	After 6, 12 and 18 months.	Yes
Secondary	Procedure success	Procedure success defined as achievement of a final diameter stenosis of <30% by QCA, using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay or 7 days after procedure, whichever came first.	During hospital stay or 7 days after procedure, whichever came first.	Yes
Secondary	Device success	Successful delivery of the balloon or stent to the target lesion site in the coronary artery; and appropriate balloon inflation and deflation or stent deployment; and successful removal of the balloon or the delivery system.	1 day (During procedure)	Yes