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

NCT ID: NCT02400632

Last Updated: 2020-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-12-30

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MAGIC-TOUCH Drug-eluting balloon

in-stent restenosis treated with drug-eluting balloon

Group Type: EXPERIMENTAL

MAGIC-TOUCH Drug-eluting Balloon

Intervention Type: DEVICE

in-stent restenosis treated with drug eluting balloon

Interventions

MAGIC-TOUCH Drug-eluting Balloon

in-stent restenosis treated with drug eluting balloon

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scitech Produtos Medicos Ltda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre Abizaid, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dante Pazzanese de Cardiologia

Locations

Hospital Bandeirantes

São Paulo, São Paulo, Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

MAGIC TOUCH

Identifier Type: -

Identifier Source: org_study_id