MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the efficacy of MagicTouch DCB in reducing late lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary Angiography / Intravascular Ultrasound examination for the treatment of coronary artery lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.

Detailed Description
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Prospective, multicenter, randomized study designed to enroll 60 subjects with In-stent Restenosis, To demonstrate the efficacy of MagicTouch Drug-Coated Balloon in reducing late lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary Angiography / Intravascular Ultrasound examination for the treatment of coronary artery lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.

Official Title
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Assessment of the Novel MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: MAGIC-TOUCH Drug-eluting Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be ≥18 and ≤ 80 years of age Symptomatic ischemic heart disease; Acceptable candidate for Coronary Artery Bypass Graft (CABG) or Angioplasty; Target lesion located in a native coronary artery Target lesion (maximum length is 15 mm by visual estimate) covered by a single balloon; Reference vessel diameter must be ≥3.0 to ≤ 3.5 mm by visual estimate; Target lesion ≥50% and <100% stenosed by visual estimate Restenosis of initially stented main vessel. Exclusion Criteria: Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure; Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure; Lesions in bypass grafts or bifurcations Any non-target vessel or lesion intended to be treated during the index procedure, which is an unprotected left main, ostial lesion, chronic total occlusion (CTO), heavily calcified, bifurcation, vein grafts, have angiographic evidence of thrombus, be anything requiring atherectomy, thrombectomy, or pre-treatment with anything other than balloon angioplasty; Patient presents with cardiogenic shock; Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion Unprotected left main coronary artery disease with ≥50% stenosis; Totally occluded target vessel (TIMI flow 0); Calcified target lesion(s) which cannot be successfully pre-dilated; A significant (>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single balloon Diffuse distal disease to target lesion with impaired runoff; Left ventricular ejection fraction (LVEF) ≤30% (LVEF must be obtained within 1 months prior to the index procedure).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: MAGIC-TOUCH Drug-eluting balloon<br>in-stent restenosis treated with drug-eluting balloon | Device: MAGIC-TOUCH Drug-eluting Balloon<br>* in-stent restenosis treated with drug eluting balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy assessed by the percentage (%) of in-stent neointimal tissue formation evaluated by Intravascular Ultrasound (IVUS) |  | 6-months after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by the composite rate for major adverse cardiac events at 12 months. (MACE: cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and Target vessel revascularization (TVR) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug-eluting balloon, in-stent restenosis