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

Coronary Artery Disease Clinical Trial

— MAGIC-TOUCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400632
• Other study ID #: MAGIC TOUCH
• Status: Completed
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: December 30, 2019

Study information

• Verified date: March 2020
• Source: Scitech Produtos Medicos Ltda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• MAGIC-TOUCH Drug-eluting Balloon
in-stent restenosis treated with drug eluting balloon

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Scitech Produtos Medicos Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy assessed by the percentage (%) of in-stent neointimal tissue formation evaluated by Intravascular Ultrasound (IVUS)		6-months after procedure
Secondary	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