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

Biotronik

Status

Completed

Conditions

Coronary Artery Disease

Coronary Restenosis

Treatments

Device: Percutaneous coronary intervention

Study type

Interventional

Funder types

Industry

Identifiers

NCT01651390

C1105

Details and patient eligibility

About

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.

Full 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.

Enrollment

231 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has provided a written informed consent
Subject ≥ 18 years
Clinical evidence of ischemic heart disease and/or a positive functional study, stable or unstable angina pectoris or documented silent ischemia
Subject eligible for percutaneous coronary intervention
Subject acceptable candidate for coronary artery bypass surgery
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
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.
Target reference vessel diameter (visual estimation): ≥ 2.0 and ≤ 4.0 mm
Target lesion length (visual estimation): ≥ 6.0 and ≤ 28.0 mm
Target lesion stenosis (visual estimation): > 50 % and ≤ 100 %
Target lesion in a native coronary artery

Exclusion criteria

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.
Evidence of acute ST-segment-elevation myocardial infarction within 48 hours prior to index procedure according to the universal definition of myocardial infarction
Subjects with acute cardiac decompensation or acute cardiogenic shock
Subject with a life expectancy of less than 18 month
In the investigators opinion subject who will not be able to comply with the follow up requirements
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)
Thrombus in the target vessel
Target lesion located in left main coronary artery
Documented left ventricular ejection fraction (LVEF) ≤ 30%
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
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)
Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached
Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study
Previously enrolled in this trial