Coronary Artery DiseasePhase 3MAGIC-TOUCHNCT02400632
MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions
A Phase 3 study testing MAGIC-TOUCH Drug-eluting Balloon in people with Coronary Artery Disease, run by Scitech Produtos Medicos SA at 3 sites in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- MAGIC-TOUCH Drug-eluting Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesBrazil
- Study dates
- Jun 2015to 30 Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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).
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Hospital Bandeirantes
São Paulo, São Paulo
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo
About this study
Official title: Assessment of the Novel MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions
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.
Read the 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
- Being tested
- MAGIC-TOUCH Drug-eluting Balloon
- Keywords
- drug-eluting balloon, in-stent restenosis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGIC-TOUCH Drug-eluting BalloonDevice
in-stent restenosis treated with drug eluting balloon
| Study group | Role | What they receive |
|---|---|---|
| MAGIC-TOUCH Drug-eluting balloon | Experimental | in-stent restenosis treated with drug-eluting balloon Receives: Device: MAGIC-TOUCH Drug-eluting Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy assessed by the percentage (%) of in-stent neointimal tissue formation evaluated by Intravascular Ultrasound (IVUS)
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startJun 2015
- Primary completion30 Jul 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scitech Produtos Medicos SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandre Abizaid, PhD, Principal investigator, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400632
- Sponsor's protocol ID
- MAGIC TOUCH
- Acronym
- MAGIC-TOUCH
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2015
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Novel MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions
- ClinicalTrials.gov ID
- NCT02400632
- Acronym / sponsor ID
- MAGIC-TOUCH / MAGIC TOUCH
- Conditions
- Coronary Artery Disease
- Keywords
- drug-eluting balloon, in-stent restenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Scitech Produtos Medicos SAIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAGIC-TOUCH Drug-eluting balloon | Experimental | Device: MAGIC-TOUCH Drug-eluting Balloonin-stent restenosis treated with drug-eluting balloon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAGIC-TOUCH Drug-eluting Balloonin-stent restenosis treated with drug eluting balloon | Device | MAGIC-TOUCH Drug-eluting balloon |
Primary outcome
Efficacy assessed by the percentage (%) of in-stent neointimal tissue formation evaluated by Intravascular Ultrasound (IVUS)
Time frame: 6-months after procedure
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Abizaid, PhD principal investigator
Instituto Dante Pazzanese de Cardiologia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MAGIC-TOUCH Drug-eluting Balloon in people with Coronary Artery Disease, run by Scitech Produtos Medicos SA at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy assessed by the percentage (%) of in-stent neointimal tissue formation evaluated by Intravascular Ultrasound (IVUS) (time frame: 6-months after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.