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

• Sponsor: Scitech Produtos Medicos Ltda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02400632
• Collaborator: (none)
• Enrollment: 60
• Locations: 3
• Arm: 1
• Actual Duration (Months): 55
• Patients Per Site: 20
• Patients Per Site Per Month: 0.4

Study Details

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.

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Jun 1, 2015
• Actual Primary Completion Date: Jul 30, 2019
• Actual Study Completion Date: Dec 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Efficacy assessed by the percentage (%) of in-stent neointimal tissue formation evaluated by Intravascular Ultrasound (IVUS) [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) [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Bandeirantes	São Paulo	SP	Brazil
2	Instituto Dante Pazzanese de Cardiologia	São Paulo	SP	Brazil
3	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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Scitech Produtos Medicos Ltda
• ClinicalTrials.gov Identifier: NCT02400632
• Other Study ID Numbers: MAGIC TOUCH
• First Posted: Mar 27, 2015
• Last Update Posted: Mar 17, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Scitech Produtos Medicos Ltda: drug-eluting balloon; in-stent restenosis
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

No Results Posted as of Mar 17, 2020