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In-Stent RestenosisMAGICAL ISRNCT05908331

MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions

A study testing Sirolimus Drug Coated Balloon and Plan balloon Angioplasty (POBA) in people with In-Stent Restenosis and Cardiovascular Diseases, run by Concept Medical Inc. at 28 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis. Read more about this study

Who is it for?
Ages 18 to 110 years
What is being tested?
Sirolimus Drug Coated Balloon and Plan balloon Angioplasty (POBA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
492 participants
Where
28 sitesUnited States
Study dates
16 Apr 2024to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is at least 18 years old
  • Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
  • Patient with an indication for PCI due to suspected in-stent restenosis
  • Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:
  • Angiographic Inclusion Criteria:
  • In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)
Show all 14Show fewer
  • Target lesion must have visually estimated stenosis ≥50% and less than 100% diameter stenosis in symptomatic patients; or a visually estimated target lesion diameter stenosis of ≥70%, or by evidence of ischemia by coronary physiology (fractional flow reserve [FFR] ≤0.80 or non-hyperemic pressure ratio [NHPR] ≤0.89) in absence of symptoms
  • Successful lesion preparation (residual stenosis <30%), without complications (no or slow flow, flow-limiting dissection, perforation, distal embolization) and without plan for stenting
  • Target lesion in a native coronary artery
  • Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion
  • Target reference vessel diameter (visual estimation) >2.0 and ≤4.0 mm
  • Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and can be covered by only one balloon
  • One ISR target lesion (overlapping stents are allowed) to be treated per patient and in single major coronary artery or side branch (reference vessel diameter >2.0 mm)
  • Other coronary lesions (ISR or non-ISR) in non-target vessel are allowed and may be treated by any approved interventional device, but must be treated successfully prior to randomization

Who cannot join

  • General Exclusion Criteria (all must be absent for the patient to be eligible):
  • STEMI within 72 hours of presentation to the first treating hospital, whether a transfer facility or the study hospital
  • NSTEACS in whom the biomarkers have not peaked
  • PCI within the 24 hours prior to the index procedure (not including PCI performed in non-target lesions during the index procedure)
  • Prior DCB treatment (coronary or off-label peripheral) of target lesion ISR
  • Cardiogenic shock (defined as persistent hypotension [systolic blood pressure <90 mm Hg] or requiring vasoactive or hemodynamic support, including IABP)
Show all 44Show fewer
  • Subject is intubated
  • Known left ventricular ejection fraction <30%
  • Relative or absolute contraindication to DAPT for at least 1 month (e.g., planned surgeries that cannot be delayed)
  • Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
  • If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
  • Hemoglobin <9 g/dL
  • Platelet count <100,000 cells/mm3 or >700,000 cells/mm3
  • White blood cell count <3,000 cells/mm3
  • Active infection undergoing treatment
  • Clinically significant liver disease
  • Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be <30ml/min by the MDRD formula
  • Active peptic ulcer or active bleeding from any site
  • Bleeding from any site requiring active medical attention within the prior 8 weeks
  • History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions
  • Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA
  • Known allergy to the study device components or protocol-required concomitant medications:
  • sirolimus (as well as other limus drugs, analogues, or similar compounds), aspirin, clopidogrel and prasugrel and ticagrelor, heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated
  • Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduce life expectancy to <24 months (e.g. cancer, heart failure, lung disease, severe valvular disease)
  • Patient is participating in or plans to participate in any other investigational drug or device trial that has not reached its primary endpoint
  • Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before index procedure)
  • Women who intend to become pregnant within 12 months after the index procedure
  • Patient has received an organ transplant or is on a waiting list for an organ transplant
  • Patient has received chemotherapy within 30 days before the index procedure or scheduled to receive chemotherapy any time after the index procedure
  • Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease. Inhaled steroid and steroid use for contrast- allergy prophylaxis or treatment are allowed
  • Angiographic Exclusion Criteria (visual estimate) (all must be absent for the patient to be eligible):
  • More than 1 ISR lesion in the target vessel in segments that cannot be treated by a single 40mm length DCB (see Angiographic Inclusions #5 and #6 above)
  • ISR lesion in the target vessel in a segment that corresponds to a previously established/documented bare metal stent (BMS)
  • Unprotected left main lesions >50% or left main intervention
  • Primary PCI for STEMI
  • Coronary artery disease judged more suitable for surgical revascularization per guidelines and local heart team discussion
  • Another lesion in either the target vessel or non-target vessel is present that requires or has a high probability of requiring PCI within 12 months after the index procedure
  • Prior brachytherapy or DCB treatment of target lesion
  • Target lesion is a bifurcation restenosis involving both branches of a bifurcation in which the side branch reference vessel diameter is >2.0 mm
  • Target lesions located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
  • Target lesion contains large thrombus
  • Target lesion is heavily calcified
  • Target lesion is a chronic total occlusion (or subtotal) without adequate lesion preparation.* Total and subtotal occlusions may be enrolled assuming they can be crossed with a wire and demonstrate TIMI grade 3 flow at the time of randomization.
  • Diffuse distal disease to target lesion with impaired runoff

Trial locations and contacts

28 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dario Gattuso contact

+393292467132

dario@conceptmedical.com

Farhana Siddique contact

+919725495366

farhana@conceptmedical.com

28 sites in 1 country

United States28 sites, 28 recruiting

  • Cardiology, PC - Princeton Baptist Medical Center

    Birmingham, Alabama, 35211

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Jenifer M Kaufman, 01-617-632-8956, jmkaufma@bidmc.harvard.edu

    Robert Yeh

    Not yet recruiting

  • Cheek-Powell Heart and Vascular Pavilion

    Clearwater, Florida, 33756

    Bernardo Stein

    Bernardo Stein

    Recruiting

  • Clearwater Cardiovascular and Interventional Consultants

    Clearwater, Florida, 33756

    Jaclyn Rutledge, 1-727-467-9393, rutledgej@cccheart.com

    Bernardo Stein

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Susan Hejl, 216-445-6817, hejls@ccf.org

    Amar Krishnaswamy

    Recruiting

  • Metropolitan Heart and Vascular Institute

    Coon Rapids, Minnesota, 55433

    Derek Vang, 763-236-9347, Derek.Vang@mhvi.com

    Matthew G Whitbeck

    Not yet recruiting

  • Baylor Scott and White Heart and Vascular Hospital

    Dallas, Texas, 75226

    Rebecca Baker, 214-820-9903, rebecca.baker@bswhealth.org

    Robert Stoler

    Recruiting

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

    Savitha Shivaraj, 1 4042638204, savitha.shivaraj@va.gov

    Rajesh Sachdeva

    Recruiting

  • The Cardiac & Vascular Institute Research Foundation

    Gainesville, Florida, 32605

    Marti Roberson, (352)244-0208, Mroberson@tcavi.com

    Matheen Khuddus

    Recruiting

  • Dignity Health - Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297

    Jennifer Vermillion, 480-728-9973, jennifer.vermillion@dignityhealth.org

    Nabil Dib

    Recruiting

  • Prisma Health

    Greenville, South Carolina, 29605-5601

    Lindsey Bentley, 864-455-7377, lindsey.bentley@prismahealth.org

    Jesse Jorgensen

    Recruiting

  • Cedars - Sinai Medical Center

    Los Angeles, California, 90048

    Mitch Gheorghiu, 310 4236152, mitch.gheorghiu@cshs.org

    Raj Makkar

    Recruiting

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

    Tamara O Black, 612-863-6226, tamara.oblack@allina.com

    Yader Sandoval

    Recruiting

  • West Virginia University and Vascular Institute

    Morgantown, West Virginia, 26506

    Josh Bomabrd, 3042851980

    Ramesh Daggubati

    Recruiting

  • Centennial Medical Center

    Nashville, Tennessee, 37203

    Drew Quillen, 6154171035, cameron.quillen@hcahealthcare.com

    Brian Jefferson

    Recruiting

  • Yale University / Yale New Haven Hospital

    New Haven, Connecticut, 06519

    Recruiting

  • VA New York Harbor Healthcare System

    New York, New York, 10010

    Leandro Maranan, 347-228-6951, leandro.maranan@va.gov

    Nathaniel Smilowitz

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Natalie S. Massenburg

    Razzouk Louai

    Recruiting

  • Columbia University Medical Center/NYPH

    New York, New York, 10032

    Ajay Kirtane

    Jeffrey Moses

    Recruiting

  • Oklahoma University Health (OU Health)

    Oklahoma City, Oklahoma, 73104

    Michael Stout, 14502719060, Michael-H-Stout@ouhsc.edu

    Mohit Pahuja

    Recruiting

  • Baylor Scott & White - The Heart Hospital - Plano

    Plano, Texas, 75093

    Osniel Gonzalez Ramos, 469-814-4862, osniel.gonzalezramos@bswhealth.org

    Karim Al-Azizi

    Recruiting

  • AtlantiCare Regional Medical Center

    Pomona, New Jersey, 08240

    Jackie White, 609-404-7654, jackie.white@atlanticare.org

    Said Ashraf

    Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

    Bethany Wilson, 5032167275, bethany.wilson@providence.org

    Jason Wollmuth

    Recruiting

  • NC Heart and Vascular Research, LLC

    Raleigh, North Carolina, 27607

    James Pierre-Loius, 919-784-7695, james.pierre-louis@unchealth.unc.edu

    James P Zidar

    Not yet recruiting

  • Tampa General Hospital / University of South Florida

    Tampa, Florida, 33606

    Hiram Bezerra, 8138448287, hbezerra@usf.edu

    Hiram Bezerra

    Recruiting

  • Montefiore Medical Center - Moses Division

    The Bronx, New York, 10467

    Azeem Latib

    Judah Rauch

    Recruiting

  • Cardiology Associates Research, LLC

    Tupelo, Mississippi, 38801

    Barry Bertolet

    Barry Bertolet

    Recruiting

  • Cardiology Associates Research, LLC

    Tupelo, Mississippi, 38801

    Yvonne Ray, 662-377-5447, yray@nmhs.net

    Barry Bertolet

    Recruiting

Other trials in United States

About this study

Official title: MagicTouch Sirolimus-coated Balloon for Treatment of In-Stent Restenosis in Coronary Artery Lesions

A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis.

Subjects with prior DES implantation presenting with ISR lesions undergoing PCI will be randomized into two groups: treatment with the MagicTouch™ sirolimus-coated balloon or POBA on a 2:1 basis. Approximately 492 subjects will be enrolled in the randomized study in a maximum of 50 study sites located in the United States.

The goal is to establish the safety and efficacy of the MagicTouch™ sirolimus- coated balloon in treatment of coronary in-stent restenosis (ISR).

Read the detailed description

All subjects providing informed consent will have their medical history reviewed and will undergo a physical examination, laboratory screen, and a standardized 12-lead ECG within 7 days of procedure. Women of childbearing potential will have a pregnancy test within one week prior to the procedure. If subjects meet the inclusion and exclusion criteria of the study, they will be randomized to one of two treatment groups, and will then undergo treatment with MagicTouch™ sirolimus-coated balloon or POBA of the target ISR lesion, per trial protocol.

One pre-procedure and all post-procedure biomarker blood draws will be sent to a central core laboratory for analysis of troponin T. Evaluation of post-procedural biomarker blood draws in local laboratories are not mandated but may be performed as part of standard of care.

During the index hospitalization, patients will undergo a clinical assessment and 12-lead ECG; and they will have cardiac biomarkers drawn before the intervention to establish baseline biomarker level and confirmation that the biomarkers are falling. At least one post procedure biomarker (core lab) will be drawn at a minimum of 4 hours after PCI as part of the assessment of periprocedural myocardial infarction and significant periprocedural myocardial injury (at 6-8 hour intervals depending on whether the patient remains admitted). If no procedural complications have occurred and there are no signs of ischemia on post-procedure ECG or clinical assessment, the patient may be discharged per local practice and no additional biomarker levels need to be drawn (beyond the protocol-mandated core laboratory draw at a minimum of 4 hours). If the patient remains admitted cardiac biomarkers (core lab) should be drawn every 6-8 hours until at least 2 total post-procedural core laboratory biomarker draws have passed or clinical standard-based biomarker levels have peaked per local labs or the patient is discharged.

After hospital discharge, subjects will be followed at 30 days (+1 week), 6 months (+2 weeks), and 12 months (+1 month) and then 24, 36, 48 and 60 months (+1 month) post procedure. Yearly vital status information will be collected by telephone follow-up. At the 12-month visit, subjects will undergo 12-lead ECG, blood count, coagulation profile and blood chemistry tests. New and ongoing AEs and concomitant medications will also be assessed.

All elective angiograms performed on the target vessel during the 12-month follow-up period should be preceded by a physician evaluation, during which the physician will indicate whether the subject's clinical status warrants revascularization, i.e. the subject has clinical evidence of ischemia. All films, including unscheduled angiograms, are to be sent to the angiographic core laboratory for review. The angiographic core laboratory will be blinded.

Being tested
Sirolimus Drug Coated Balloon, Plan balloon Angioplasty (POBA)
Keywords
Drug coated balloon, Sirolimus coated balloon, ISR, Magic Touch, SCB, Concept Medical, MAGICAL ISR
Medical subject headings
Cardiovascular Diseases, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sirolimus Drug Coated BalloonDevice

    Magic TouchTM (Concept Medical) is a semi-compliant sirolimus drug coated balloon (SCB) for PCI, based on a polymer-free and nanocarrier based drug delivery technology.

  • Plan balloon Angioplasty (POBA)Device

    Plan balloon used to open clogged or narrow coronary arteries due to underlying atherosclerosis

Study groups in NCT05908331
Study groupRoleWhat they receive
MagicTouch Sirolimus-Coated BalloonExperimentalMagic TouchTM is a Sirolimus Coated Balloon catheter intended to be used in coronary applications, treats the atherosclerosis of the coronary arteries by eluting the immunosuppressant agent Sirolimus without leaving behind a metallic scaffold.
Receives: Device: Sirolimus Drug Coated Balloon
POBAActive comparatorplain old balloon angioplasty
Receives: Device: Plan balloon Angioplasty (POBA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TLF (Target Lesion Failure)

    The composite rate of cardiac death, target-vessel MI (Myocardial Infarction) or ischemia-driven TLR (Target Lesion Revascularization)

    Measured: 12 months

Secondary outcomes (21)

  1. MACE (Major adverse cardiovascular events)

    composite of cardiovascular mortality, any MI (Myocardial Infarction), and ID-TLR (Ischemia-Driven Target Lesion Revascularization)

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  2. TVF (Target vessel failure)

    composite of cardiovascular mortality, ID-TVR (Ischemia-Driven Target Vessel Revascularization), and TV-MI (Target Vessel Myocardial Infarction)

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  3. Any revascularization

    any repeat PCI or CABG

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  4. ID-TLR (Ischemia-Driven Target Lesion Revascularization)

    Repeat revascularization of the target lesion due to recurrent ischemia

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  5. TLR (Target Lesion Revascularization)

    Repeat revascularization of the target lesion

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  6. ID-TVR (Ischemia-Driven Target Vessel Revascularization)

    Repeat revascularization of the target vessel due to recurrent ischemia

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  7. TVR (Target Vessel Revascularization)

    Repeat revascularization of the target vessel

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  8. All-cause mortality

    Death from any cause

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  9. Cardiovascular mortality

    Death due to coronary artery disease or complications of coronary treatment

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  10. Any MI (Myocardial Infarction)

    Any Myocardial Infarction

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  11. TV-MI (Target Vessel Myocardial Infarction)

    Myocardial Infarction related to the target vessel

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  12. Q-wave MI (Myocardial Infarction)

    Myocardial Infarction demonstrated by new pathological Q waves on ECG

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  13. Non-Q-wave MI (Myocardial Infarction)

    Myocardial Infarction not demonstrated by new pathological Q waves on ECG

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  14. Cardiovascular mortality or MI (Myocardial Infarction)

    Either cardiovascular death or any Myocardial Infarction

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  15. All-cause mortality or MI (Myocardial Infarction)

    Either death from any cause or any Myocardial Infarction

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  16. All-cause mortality, MI (Myocardial Infarction), or TVR (Target Vessel Revascularization)

    Death from any cause, any Myocardial Infarction, or Target Vessel Revascularization

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  17. Any definite or probable target lesion stent thrombosis by ARC (Academic Research Consortium) criteria

    Definite or probable stent thrombosis in the target lesion according to the ARC (Academic Research Consortium) definition

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  18. Probable target lesion stent thrombosis by ARC (Academic Research Consortium) criteria

    Probable stent thrombosis in the target lesion according to the ARC definition

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  19. Definite target lesion stent thrombosis by ARC (Academic Research Consortium) criteria

    Definite stent thrombosis in the target lesion according to the ARC definition

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  20. BARC (Bleeding Academic Research Consortium) type 3-5 bleeding

    Significant or severe bleeding according to the BARC definition

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

  21. Procedure Success

    ability to deliver the device and achieve a less than 30% residual stenosis by QCA (quantitative coronary angiography) without major complication or bailout stenting

    Measured: 30 days and 6, 12, 24, 36, 48, and 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2023
  2. Study start16 Apr 2024
  3. Primary completionSep 2025 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2:1 randomized trial (MagicTouchTM vs. "plain old" balloon angioplasty \[POBA\])
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
492 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05908331
Sponsor's protocol ID
CM-US-R02
Acronym
MAGICAL ISR
Status last verified
Feb 2025
First submitted
1 Jun 2023
Last updated
25 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Sirolimus Drug Coated Balloon and Plan balloon Angioplasty (POBA) in people with In-Stent Restenosis and Cardiovascular Diseases, run by Concept Medical Inc. at 28 sites in United States.

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 14 inclusion and 44 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: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dario Gattuso (+393292467132, dario@conceptmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TLF (Target Lesion Failure) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05908331.

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 25 Feb 2025.

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