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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Artery Disease, Coronary Restenosis

Intervention / Treatment
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* Device: Percutaneous coronary intervention
* Device: Percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug coated balloon<br>Percutaneous coronary intervention with the Pantera Lux drug coated balloon. | Device: Percutaneous coronary intervention<br>* 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.<br>* Other names: BTHC (Butyryltri-n-hexyl Citrate);|
| Active Comparator: Drug eluting stent<br>Percutaneous coronary intervention with the Orsiro drug eluting stent. | Device: Percutaneous coronary intervention<br>* 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.<br>* Other names: Sirolimus eluting stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Binary restenosis in-stent and in-segment | Binary restenosis is defined as ≥50% lumen diameter stenosis as evaluated by offline QCA. | After 6 months. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| Stent thrombosis | According to Academic Research Consortium (ARC) definition (Cutlip et al. Circulation 2007; 115: 2344-2351). | After 6, 12 and 18 months. | 
| 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. | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Restenosis, Drug coated balloon, Drug eluting stent, Paclitaxel, Sirolimus