Clinical trial NCT06271590: MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels
Official title: The MAGICAL SV Trial - A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Non Inferiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus-Coated Balloon in the Treatment of Small Vessels in Patients With Coronary Artery Disease.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Native Coronary Artery Stenosis
Cardiovascular Diseases
Keywords: Drug coated balloon
Sirolimus coated balloon
De Novo
Magic Touch
SCB
Concept Medical
Small Vessel
MAGICAL SV
Lead sponsor: Concept Medical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cardiovascular Research Foundation, New York
First posted: 2024-02-22
Enrollment: 1605
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 randomized trial (MagicTouchTM Sirolimus-Coated Balloon VS Drug eluting stent (ZES or EES)
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm).

A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \~50% of enrollees.

Detailed description: Subjects with small vessel CAD (Coronary artery disease) presenting with lesions undergoing PCI (Percutaneous coronary intervention) will be randomized into two groups: treatment with the MagicTouch™ sirolimus-coated balloon or DCB (drug-coated balloon) on a 2:1 basis. Approximately 1605 subjects will be enrolled in the randomized study.

Treatment of a single lesion in a single major coronary artery or side branch will be enrolled per the inclusion and exclusion criteria. Target lesion must be located in a native coronary artery with a visually estimated diameter of\<2.75 mm to length (including tandem lesions) ≤34.0 mm by visual estimation, and diameter stenosis ≥50% to \<100% in symptomatic patients or ischemia by coronary physiology in patients without symptoms. The primary endpoint is TLF (target lesion failure) at 12 months after intervention.

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. SAQ-7 (Seattle Angina Questionnaire) will be collected at baseline, 30 days, 6 months, and 12 months and prior to any planned intervention.

Eligibility criteria: Clinical Inclusion Criteria:

1. Adult patient with an indication for PCI due to stable angina, NSTEACS, post-infarction angina or silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, FFR ≤0.80, or non-hyperemic pressure ratio \[NHPR\] ≤0.89 must be present)
2. Subject is ≥18 and \<80 years old
3. Subject is willing to comply with all protocol-required follow-up evaluations and provides written informed consent

   Angiographic Inclusion Criteria:
4. Target reference vessel diameter (visual estimation) ≤2.75 mm
5. Successful lesion preparation (residual stenosis \<30%), without flow-limiting complications (no or slow flow, dissection etc.)
6. Target lesion(s) in a native coronary artery
7. Up to two small vessel target lesions in two different vessels
8. Target lesion length (visual estimation): ≥6.0 and ≤34.0 mm and can be covered by a single 40 mm balloon
9. Target lesion diameter stenosis (visual estimation) \>30% and \<100% with Thrombolysis in Myocardial Infarction (TIMI) flow grade ≥2

Clinical Exclusion Criteria:

1. Planned (staged) intervention in the target vessel
2. ST-segment-elevation MI within 48 hours prior to index procedure
3. Subjects with acute cardiac decompensation or cardiogenic shock
4. Subject with a life expectancy of less than 24 months
5. Impaired renal function (glomerular filtration rate \[GFR\] \<30 mL/min)
6. Documented left ventricular ejection fraction (LVEF) ≤30%
7. Known allergies to acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparin, contrast medium, sirolimus or similar drugs (i.e., ABT-578 \[Zotarolimus\], biolimus, tacrolimus)
8. Relative or absolute contraindication to dual antiplatelet therapy (DAPT) for at least 1 month (e.g., planned surgeries that cannot be delayed)
9. Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
10. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
11. Hemoglobin \<9 g/dL
12. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
13. White blood cell count \<3,000 cells/mm3
14. Active infection undergoing treatment
15. Clinically significant liver disease
16. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA
17. Subject is receiving oral or intravenous immunosuppressive therapy (e.g., inhaledsteroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
18. Subject is unlikely to comply with the follow up requirements, per investigator's assessment
19. Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached
20. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study

    Angiographic Exclusion Criteria:

    All exclusion criteria apply to the target lesion(s) or target vessel(s)
21. Re-stenotic lesion(s), whether due to percutaneous old balloon angioplasty (POBA) or prior stenting
22. True bifurcation lesion (lesion involves both main and side branch\>2.5 mm) with planned treatment of both branches per investigator assessment
23. Angiographic evidence of thrombus in the target vessel
24. Myocardial bridging
25. Target lesion is heavily calcified
26. Diffuse distal disease to target lesion with impaired runoff, TIMI flow \<2
27. Non-target lesion in the target vessel requiring PCI

Note: Non-target vessel PCI is allowed at the time of index procedure if performed prior to study intervention and if successful and uncomplicated. For target lesions located in branches of the three main vessels (left anterior descending artery \[LAD\], left circumflex artery \[LCx\], right coronary artery \[RCA\]), the term target vessel refers to the branch and not the main vessel.

Primary outcomes:
measure: Target lesion failure (TLF)
timeFrame: within 12 months
Secondary outcomes:
measure: Procedural success
timeFrame: at baseline, during the procedure
measure: Target lesion failure (TLF)
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: Ischemia driven target vessel revascularization (ID-TVR)
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: Target vessel revascularization (TVR)
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: Any revascularization
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: Target vessel failure (TVF)
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: Q-wave myocardial infarction (MI)
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: Non Q-wave myocardial infarction (MI)
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: Any myocardial infarction (MI)
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: Target vessel myocardial infarction (TV MI)
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: Spontaneous myocardial infarction (MI)
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: Procedural myocardial infarction (MI)
timeFrame: Evaluated at 48 hours
measure: Cardiovascular mortality
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: All-cause mortality
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: Cardiovascular mortality or myocardial infarction (MI)
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: All-cause mortality or MI
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: All-cause mortality, myocardial infarction (MI) or target vessel revascularization (TVR)
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: Any probable or definite stent thrombosis
timeFrame: Evaluated at 48 hours
measure: Probable stent thrombosis
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
measure: Definite stent thrombosis
timeFrame: 30 days and at 6, 12, 24, 36, 48, and 60 months
Other outcomes:
measure: Angina as assessed by SAQ-7 (Seattle Angina Questionnaire)
timeFrame: Quality of Life Endpoint evaluated at 30 days, 6 months, and 12 months
Locations:
city: Gilbert
country: United States
facility: Dignity Health - Mercy Gilbert Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Clearwater
country: United States
facility: Clearwater Cardiovascular and Interventional Consultants
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Sciences Center-Jacksonville
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital / University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital /Emory School of Medice
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation (Abbott)
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Pomona
country: United States
facility: Atlanticare Regional Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: University Hospitals, Cleveland Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital - Northwell
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai/ Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Raleigh
country: United States
facility: NC Heart and Vascular Research, LLC
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals, Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Pittsburg
country: United States
facility: University of Pittsburgh Medical center (UPMC)
state: Pennsylvania
city: Plano
country: United States
facility: Baylor Scott & White The Heart Hospital - Plano
state: Texas
city: Morgantown
country: United States
facility: West Virginia University Heart & Vascular Institute
state: West Virginia
Study officials:
References: