Coronary Artery Disease, Native Coronary Artery Stenosis, Cardiovascular Diseases
Conditions
Keywords
Drug coated balloon, Sirolimus coated balloon, De Novo, Magic Touch, SCB, Concept Medical, Small Vessel, MAGICAL SV
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.
Interventions
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.
For subjects randomized to the control group (DES), the treating physician will choose an FDA cleared DES (ZES or EES) and follow lesion preparation and stent deployment according to the Instructions per use (IFU) and institutional practices.
Sponsors
Cardiovascular Research Foundation, New York
Concept Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
2:1 randomized trial (MagicTouchTM Sirolimus-Coated Balloon VS Drug eluting stent (ZES or EES)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure (TLF) | within 12 months | the composite of cardiovascular mortality, target-vessel myocardial infarction (TV-MI) and ischemia driven target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | at baseline, during the procedure | defined as residual diameter stenosis \<30% (DS), no flow-limiting dissection and with post-procedure The thrombolysis in myocardial infarction (TIMI) 3 flow, without the need for bailout stenting |
| Target lesion failure (TLF) | 30 days and at 6, 12, 24, 36, 48, and 60 months | defined as the composite of cardiovascular mortality, target-vessel myocardial infarction (TVMI) and ischemia driven target lesion revascularization |
| Ischemia driven target vessel revascularization (ID-TVR) | 30 days and at 6, 12, 24, 36, 48, and 60 months | Repeat revascularization of the target lesion due to recurrent ischemia |
| Target vessel revascularization (TVR) | 30 days and at 6, 12, 24, 36, 48, and 60 months | Repeat revascularization of the target vessel |
| Any revascularization | 30 days and at 6, 12, 24, 36, 48, and 60 months | any repeat PCI |
| Target vessel failure (TVF) | 30 days and at 6, 12, 24, 36, 48, and 60 months | defined as the composite of cardiovascular mortality,ischemia driven TVR and TVMI |
| Q-wave myocardial infarction (MI) | 30 days and at 6, 12, 24, 36, 48, and 60 months | Myocardial Infarction demonstrated by new pathological Q waves on ECG |
| Non Q-wave myocardial infarction (MI) | 30 days and at 6, 12, 24, 36, 48, and 60 months | Myocardial Infarction not demonstrated by new pathological Q waves on ECG |
| Any myocardial infarction (MI) | 30 days and at 6, 12, 24, 36, 48, and 60 months | — |
| Target vessel myocardial infarction (TV MI) | 30 days and at 6, 12, 24, 36, 48, and 60 months | — |
| Procedural myocardial infarction (MI) | Evaluated at 48 hours | — |
| Cardiovascular mortality | 30 days and at 6, 12, 24, 36, 48, and 60 months | — |
| All-cause mortality | 30 days and at 6, 12, 24, 36, 48, and 60 months | — |
| Cardiovascular mortality or myocardial infarction (MI) | 30 days and at 6, 12, 24, 36, 48, and 60 months | — |
| All-cause mortality or MI | 30 days and at 6, 12, 24, 36, 48, and 60 months | — |
| All-cause mortality, myocardial infarction (MI) or target vessel revascularization (TVR) | 30 days and at 6, 12, 24, 36, 48, and 60 months | — |
| Any probable or definite stent thrombosis | Evaluated at 48 hours | — |
| Probable stent thrombosis | 30 days and at 6, 12, 24, 36, 48, and 60 months | Defined as per the Academic Research Consortium (ARC) criteria |
| Definite stent thrombosis | 30 days and at 6, 12, 24, 36, 48, and 60 months | Defined as per the Academic Research Consortium (ARC) criteria |
| Spontaneous myocardial infarction (MI) | 30 days and at 6, 12, 24, 36, 48, and 60 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Angina as assessed by SAQ-7 (Seattle Angina Questionnaire) | Quality of Life Endpoint evaluated at 30 days, 6 months, and 12 months | Angina will be assessed at these specified timepoints and prior to any invasive procedure -Last angina assessment prior to any repeat coronary angiogram will be considered and subsequent assessments will be censored |
Countries
United States
Contacts
Primary ContactFarhana Siddique
Backup ContactDario Gattuso
Outcome results
None listed