Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in In-Stent Restenosis Lesions (DEBREST)

Study Overview
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Brief Summary
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The purpose of this study is to assess safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of In-Stent Restenosis lesions in native coronary arteries.

Detailed Description
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The DEBREST clinical trial is a prospective, non-randomized, multicenter, interventional study evaluating the investigational Danubio Paclitaxel Eluting Coronary Balloon in patients with in-stent restenosis (ISR) lesion(s) with reference vessel diameter ≥2.5 mm and ≤3.5 mm. The trial will allow the treatment of up to two ISR (either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) ISR) per patient in native coronary arteries with mandatory predilatation with a conventional balloon. The DEBREST clinical trial will enroll 60 patients. All patients will receive Quantitative Coronary Angiography (QCA) before and after Drug-Eluting Balloon (DEB) inflation and at 6 months follow-up. All patients will have a clinical follow-up at 1, 6 and 12 months.

Official Title
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Assessment of the Safety and Efficacy of the Danubio Paclitaxel-Eluting Balloon for the Treatment of In-Stent Restenosis Lesions in Native Coronary Arteries.

Conditions
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In-stent Coronary Artery Restenosis

Intervention / Treatment
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* Device: Danubio paclitaxel-eluting balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Restenotic lesion in a native coronary artery. First ISR after BMS or DES implantation. Reference diameter > 2.5 and ≤ 3.5mm. Target lesion length: ≤ 21mm. Up to three restenotic lesions per patient. Single restenotic lesion per vessel. The lesion must be treated with the trial device Danubio. During the index procedure, in case of Treatment of a lesion in a vessel other than the target vessel or, Treatment of a lesion in the target vessel proximal or distal to the target restenotic lesion, The treatment of the non-target lesion must be successfully performed with a Drug-Eluting Stent before the treatment of the target lesion (residual stenosis <30%; stent well deployed; no residual dissection; normal TIMI flow; no chest pain; ECG unchanged compared to pre-procedural ECG). Successful predilatation with a conventional balloon providing good angiographic result (i.e. absence of dissection, TIMI > III). The patient is at least 18 years of age. Non menopausal women must provide a negative pregnancy test and use a double contraception until the end of the study. The patient has clinical evidence of ischemic heart disease, stable or unstable angina with signs of ischemia, silent ischemia, or a positive functional test. The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG) surgery. The patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Ethics Committee (EC). The patient agrees to return to the same research facility for required angiographic post-procedure follow-up visit at 6 months . Exclusion Criteria: Bifurcation lesion(s) including left main. The Danubio covers beyond the lesion proximally and distally with < 2 mm. Heavily calcified lesions. Severe tortuous lesions. Evidence of extensive thrombosis or dissection within target vessel before the intervention. Documented Left Ventricular Ejection Fraction (LVEF) < 30% at most recent evaluation. A known hypersensitivity or contraindication to aspirin, heparin or bivaluridin, ticlopidine or clopidogrel, paclitaxel or drugs in similar class, contrast media, which cannot be adequately pre-medicated. Chronic total occlusion (CTO). A serum creatinine level > 2.0 mg/dL within seven days prior to index procedure. Evidence of an acute MI within 72 hours of the intended index procedure (according to ARC definition). Planned PCI of any vessel within 30 days post-procedure. Surgery 30 days prior to this PCI or anticipated surgery 6-months post this PCI. During the index procedure, the target lesion requires treatment with a device other than PTCA prior to use of Danubio (including but not limited to cutting balloon, any atherectomy, any laser, thrombectomy, etc.). Second restenotic lesion requiring treatment in target vessel. History of a stroke or transient ischemic attack (TIA) within the prior 6 months Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months. History of bleeding diathesis or coagulopathy or will refuse blood transfusions. Concurrent medical condition with a life expectancy of less than 12 months. Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy. Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Danubio<br> | Device: Danubio paclitaxel-eluting balloon<br>* Inflation of the Danubio Paclitaxel Eluting Balloon in in-stent restenosis lesions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent Late Lumen Loss (mm) | In-stent Late Lumen Loss by Quantitative Coronary Angiography (QCA) | 6 months post-procedure (up to 26 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment Late Lumen Loss (mm) | In-segment Late Lumen Loss by QCA. | 6 months post-procedure (up to 26 weeks) | 
| Angiographic binary restenosis rate (%) | Angiographic binary restenosis rate (%) by QCA. | 6 months post-procedure (up to 26 weeks) | 
| Major Adverse Cardiac Event (MACE) rate | MACE defined as death, Myocardial Infarction (MI, Q waves and non-Q waves), emergent cardiac bypass surgery, or any target lesion revascularization (repeat Percutaneous transluminal coronary angioplasty (PTCA) or Coronary artery bypass grafting (CABG)). | In-hospital, 1, 6 and 12 months post-procedure. | 
| Clinically-driven Target Lesion Revascularization (TLR) |  | 1, 6 and 12 months post-procedure | 
| Target Vessel Failure (TVF) |  | 1, 6 and 12 months post-procedure | 
| Target Vessel Revascularization (TVR) |  | 1, 6 and 12 months post-procedure | 
| Angiographic success |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Restenosis, Paclitaxel-eluting balloon, Angioplasty, Coronary artery disease, Coronary artery stenosis