Coronary Artery Disease
Conditions
Keywords
drug-eluting balloon, in-stent restenosis
Brief summary
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
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.
Interventions
DEVICEMAGIC-TOUCH Drug-eluting Balloon
in-stent restenosis treated with drug eluting balloon
Sponsors
Scitech Produtos Medicos Ltda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The patient must be ≥18 and ≤ 80 years of age 2. Symptomatic ischemic heart disease; 3. Acceptable candidate for Coronary Artery Bypass Graft (CABG) or Angioplasty; 4. Target lesion located in a native coronary artery 5. Target lesion (maximum length is 15 mm by visual estimate) covered by a single balloon; 6. Reference vessel diameter must be ≥3.0 to ≤ 3.5 mm by visual estimate; 7. Target lesion ≥50% and \<100% stenosed by visual estimate 8. Restenosis of initially stented main vessel.
Exclusion criteria
1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure; 2. Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure; 3. Lesions in bypass grafts or bifurcations 4. 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; 5. Patient presents with cardiogenic shock; 6. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion 7. Unprotected left main coronary artery disease with ≥50% stenosis; 8. Totally occluded target vessel (TIMI flow 0); 9. Calcified target lesion(s) which cannot be successfully pre-dilated; 10. A significant (\>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single balloon 11. Diffuse distal disease to target lesion with impaired runoff; 12. Left ventricular ejection fraction (LVEF) ≤30% (LVEF must be obtained within 1 months prior to the index procedure).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy assessed by the percentage (%) of in-stent neointimal tissue formation evaluated by Intravascular Ultrasound (IVUS) | 6-months after procedure |
Secondary
| Measure | 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 |
Countries
Brazil
Outcome results
None listed