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

March 16, 2020 updated by: Scitech Produtos Medicos Ltda

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 6-months after procedure
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)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scitech Produtos Medicos Ltda

Investigators

  • Principal Investigator: Alexandre Abizaid, PhD, Instituto Dante Pazzanese de Cardiologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAGIC TOUCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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