Clinical trial NCT01651390: Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Restenosis
Keywords: Restenosis
Drug coated balloon
Drug eluting stent
Paclitaxel
Sirolimus
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Late lumen loss (in-stent)
timeFrame: After 6 months.
Secondary outcomes:
measure: Percent diameter stenosis in-stent and in-segment
timeFrame: After 6 months.
measure: Binary restenosis in-stent and in-segment
timeFrame: After 6 months.
measure: Mean lumen diameter in-stent and in-segment
timeFrame: After 6 months.
measure: Type of reoccurrence according to Mehran classification
timeFrame: After 6, 12 and 18 months.
measure: Target lesion failure (TLF)
timeFrame: After 6 and 18 months.
measure: Target vessel failure (TVF)
timeFrame: After 6, 12 and 18 months.
measure: Stent thrombosis
timeFrame: After 6, 12 and 18 months.
measure: Procedure success
timeFrame: During hospital stay or 7 days after procedure, whichever came first.
measure: Device success
timeFrame: 1 day (During procedure)
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg-Bad Krozingen
city: Bad Segeberg
country: Germany
facility: Heart Center Segeberger Kliniken
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Charité Centrum 11 für Herz-, Kreislauf- und Gefäßmedizin
city: Berlin
country: Germany
facility: Innere Medizin Kardiologie - Charité Centrum 11, Campus Benjamin Franklin
city: Coburg
country: Germany
facility: Kardiologie - Angiologie - Pneumologie, Klinikum Coburg
city: Essen
country: Germany
facility: Contilia Heart- and Vascular Center, Elisabeth Krankenhaus
city: Hamburg
country: Germany
facility: Medical Care Center Prof. Mathey, Prof. Schofer
city: Minden
country: Germany
facility: Kardiologie /Intern. Intensivmedizin, Johannes Wesling Klinikum Minden
city: Munich
country: Germany
facility: Klinikum Schwabing
city: Munich
country: Germany
facility: LMU - Klinikum der Universität München
city: Munich
country: Germany
facility: Klinikum Bogenhausen
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Klinik für Kardiologie
city: Villingen-Schwenningen
country: Germany
facility: Innere Medizin III Kardiologie, Kliniken Villingen
city: Riga
country: Latvia
facility: Cardiology, Pauls Stradins Clinical University Hospital
Study officials:
affiliation: Contilia Heart- and Vascular Center, Elisabeth Krankenhaus, Klara-Kopp-Weg 1, 45138 Essen, Germany
name: Christoph K Naber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1161/CIRCULATIONAHA.106.685313.
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. doi: 10.1161/01.cir.100.18.1872.