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

NCT02400632 | Completed Phase 3

• 1 other identifier: MAGIC TOUCH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Coronary Artery Disease

Keywords

drug-eluting balloon; in-stent restenosis

Outcome Measures

Primary Outcomes (1)

• Efficacy assessed by the percentage (%) of in-stent neointimal tissue formation evaluated by Intravascular Ultrasound (IVUS)

  6-months after procedure

Secondary Outcomes (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

Study Arms (1)

MAGIC-TOUCH Drug-eluting balloon

EXPERIMENTAL

in-stent restenosis treated with drug-eluting balloon

Device: MAGIC-TOUCH Drug-eluting Balloon

Interventions

MAGIC-TOUCH Drug-eluting Balloon DEVICE

in-stent restenosis treated with drug eluting balloon

MAGIC-TOUCH Drug-eluting balloon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be ≥18 and ≤ 80 years of age
• Symptomatic ischemic heart disease;
• Acceptable candidate for Coronary Artery Bypass Graft (CABG) or Angioplasty;
• Target lesion located in a native coronary artery
• Target lesion (maximum length is 15 mm by visual estimate) covered by a single balloon;
• Reference vessel diameter must be ≥3.0 to ≤ 3.5 mm by visual estimate;
• Target lesion ≥50% and \<100% stenosed by visual estimate
• Restenosis of initially stented main vessel.

You may not qualify if:

• Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure;
• Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure;
• Lesions in bypass grafts or bifurcations
• 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;
• Patient presents with cardiogenic shock;
• Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
• Unprotected left main coronary artery disease with ≥50% stenosis;
• Totally occluded target vessel (TIMI flow 0);
• Calcified target lesion(s) which cannot be successfully pre-dilated;
• A significant (\>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single balloon
• Diffuse distal disease to target lesion with impaired runoff;
• Left ventricular ejection fraction (LVEF) ≤30% (LVEF must be obtained within 1 months prior to the index procedure).

Sponsors & Collaborators

• Scitech Produtos Medicos Ltda: lead

Study Sites (3)

Hospital Bandeirantes

São Paulo, São Paulo, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Location

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

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Alexandre Abizaid, PhD

  Instituto Dante Pazzanese de Cardiologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 27, 2015
• Study Start: June 1, 2015
• Primary Completion: July 30, 2019
• Study Completion: December 30, 2019
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

BR (3)