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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02400632
Recruitment Status : Completed
First Posted : March 27, 2015
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Scitech Produtos Medicos Ltda

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: MAGIC-TOUCH Drug-eluting Balloon Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Novel MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions
Actual Study Start Date : June 2015
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

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




Primary Outcome Measures :
  1. Efficacy assessed by the percentage (%) of in-stent neointimal tissue formation evaluated by Intravascular Ultrasound (IVUS) [ Time Frame: 6-months after procedure ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400632


Locations
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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
São Paulo, SP, Brazil
Sponsors and Collaborators
Scitech Produtos Medicos Ltda
Investigators
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Principal Investigator: Alexandre Abizaid, PhD Instituto Dante Pazzanese de Cardiologia
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Responsible Party: Scitech Produtos Medicos Ltda
ClinicalTrials.gov Identifier: NCT02400632    
Other Study ID Numbers: MAGIC TOUCH
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Keywords provided by Scitech Produtos Medicos Ltda:
drug-eluting balloon
in-stent restenosis
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases