Back to resultsMagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions (MAGIC-TOUCH)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
MAGIC-TOUCH Drug-eluting Balloon
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring drug-eluting balloon, in-stent restenosis
Eligibility Criteria
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).
Sites / Locations
- Hospital Bandeirantes
- Instituto Dante Pazzanese de Cardiologia
- Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MAGIC-TOUCH Drug-eluting balloon
Arm Description
in-stent restenosis treated with drug-eluting balloon
Outcomes
Primary Outcome Measures
Efficacy assessed by the percentage (%) of in-stent neointimal tissue formation evaluated by Intravascular Ultrasound (IVUS)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT02400632
First Posted
March 17, 2015
Last Updated
March 16, 2020
Sponsor
Scitech Produtos Medicos Ltda
1. Study Identification
Unique Protocol Identification Number
NCT02400632
Brief Title
MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions
Acronym
MAGIC-TOUCH
Official Title
Assessment of the Novel MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scitech Produtos Medicos Ltda
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
drug-eluting balloon, in-stent restenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MAGIC-TOUCH Drug-eluting balloon
Arm Type
Experimental
Arm Description
in-stent restenosis treated with drug-eluting balloon
Intervention Type
Device
Intervention Name(s)
MAGIC-TOUCH Drug-eluting Balloon
Intervention Description
in-stent restenosis treated with drug eluting balloon
Primary Outcome Measure Information:
Title
Efficacy assessed by the percentage (%) of in-stent neointimal tissue formation evaluated by Intravascular Ultrasound (IVUS)
Time Frame
6-months after procedure
Secondary Outcome Measure Information:
Title
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)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Abizaid, PhD
Organizational Affiliation
Instituto Dante Pazzanese de Cardiologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Bandeirantes
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
City
São Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions
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