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

NCT05908331 | Recruiting DMC FDA Device

• 1 other identifier: CM-US-R02
• Study Type: interventional
• Target: 492
• Locations: 1 country
• Sites: 28

Brief 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. 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).

Conditions

In-Stent Restenosis; Cardiovascular Diseases; Coronary Artery Disease

Keywords

Drug coated balloon; Sirolimus coated balloon; ISR; Magic Touch; SCB; Concept Medical; MAGICAL ISR

Outcome Measures

Primary Outcomes (1)

• TLF (Target Lesion Failure)

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

  12 months

Secondary Outcomes (21)

• MACE (Major adverse cardiovascular events)

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

• TVF (Target vessel failure)

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

• Any revascularization

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

• ID-TLR (Ischemia-Driven Target Lesion Revascularization)

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

• TLR (Target Lesion Revascularization)

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

Other Outcomes (1)

• Angina as assessed by SAQ-7 (Seattle Angina Questionnaire)

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

Study Arms (2)

MagicTouch Sirolimus-Coated Balloon

EXPERIMENTAL

Magic 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.

Device: Sirolimus Drug Coated Balloon

POBA

ACTIVE COMPARATOR

plain old balloon angioplasty

Device: Plan balloon Angioplasty (POBA)

Interventions

Sirolimus Drug Coated Balloon DEVICE

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.

MagicTouch Sirolimus-Coated Balloon

Plan balloon Angioplasty (POBA) DEVICE

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

POBA

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Concept Medical Inc.: lead
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (28)

Cardiology, PC - Princeton Baptist Medical Center

Birmingham, Alabama, 35211, United States

RECRUITING

Dignity Health - Mercy Gilbert Medical Center

Gilbert, Arizona, 85297, United States

RECRUITING

Cedars - Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Yale University / Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

RECRUITING

Cheek-Powell Heart and Vascular Pavilion

Clearwater, Florida, 33756, United States

RECRUITING

Clearwater Cardiovascular and Interventional Consultants

Clearwater, Florida, 33756, United States

RECRUITING

The Cardiac & Vascular Institute Research Foundation

Gainesville, Florida, 32605, United States

RECRUITING

Tampa General Hospital / University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Metropolitan Heart and Vascular Institute

Coon Rapids, Minnesota, 55433, United States

NOT YET RECRUITING

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Cardiology Associates Research, LLC

Tupelo, Mississippi, 38801, United States

RECRUITING

Cardiology Associates Research, LLC

Tupelo, Mississippi, 38801, United States

RECRUITING

AtlantiCare Regional Medical Center

Pomona, New Jersey, 08240, United States

RECRUITING

VA New York Harbor Healthcare System

New York, New York, 10010, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

RECRUITING

Montefiore Medical Center - Moses Division

The Bronx, New York, 10467, United States

RECRUITING

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607, United States

NOT YET RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Oklahoma University Health (OU Health)

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

RECRUITING

Prisma Health

Greenville, South Carolina, 29605-5601, United States

RECRUITING

Centennial Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

Baylor Scott and White Heart and Vascular Hospital

Dallas, Texas, 75226, United States

RECRUITING

Baylor Scott & White - The Heart Hospital - Plano

Plano, Texas, 75093, United States

RECRUITING

West Virginia University and Vascular Institute

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dario Gattuso

CONTACT

+393292467132; dario@conceptmedical.com

Farhana Siddique

CONTACT

+919725495366; farhana@conceptmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will be blinded till the primary endpoint of 12 months and the angiographic core laboratory will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2:1 randomized trial (MagicTouchTM vs. "plain old" balloon angioplasty \[POBA\])

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 18, 2023
• Study Start: April 16, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

US (28)