MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions (MAGIC-TOUCH)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: MAGIC-TOUCH Drug-eluting Balloon

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil
      • Hospital Bandeirantes
    • São Paulo, SP, Brazil
      • Instituto Dante Pazzanese de Cardiologia
    • São Paulo, SP, Brazil
      • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MAGIC-TOUCH Drug-eluting balloon; in-stent restenosis treated with drug-eluting balloon	Device: MAGIC-TOUCH Drug-eluting Balloon; in-stent restenosis treated with drug eluting balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Scitech Produtos Medicos Ltda
• Investigators: Principal Investigator: Alexandre Abizaid, PhD, Instituto Dante Pazzanese de Cardiologia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: in-stent restenosis; drug-eluting balloon
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: MAGIC TOUCH