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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06271590
Other study ID # CM-US-R03
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date April 2031

Study information

Verified date February 2024
Source Concept Medical Inc.
Contact Farhana Siddique
Phone +919725495366
Email farhana@conceptmedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1605
Est. completion date April 2031
Est. primary completion date April 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Device:
Sirolimus Drug Coated Balloon
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.
Drug eluting stents (DES)
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Concept Medical Inc. Cardiovascular Research Foundation, New York

Outcome

Type Measure Description Time frame Safety issue
Other Angina as assessed by SAQ-7 (Seattle Angina Questionnaire) 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
Quality of Life Endpoint evaluated at 30 days, 6 months, and 12 months
Primary Target lesion failure (TLF) the composite of cardiovascular mortality, target-vessel myocardial infarction (TV-MI) and ischemia driven target lesion revascularization within 12 months
Secondary Procedural success 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 at baseline, during the procedure
Secondary Target lesion failure (TLF) defined as the composite of cardiovascular mortality, target-vessel myocardial infarction (TVMI) and ischemia driven target lesion revascularization 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary Ischemia driven target vessel revascularization (ID-TVR) Repeat revascularization of the target lesion due to recurrent ischemia 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary Target vessel revascularization (TVR) Repeat revascularization of the target vessel 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary Any revascularization any repeat PCI 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary Target vessel failure (TVF) defined as the composite of cardiovascular mortality,ischemia driven TVR and TVMI 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary Q-wave myocardial infarction (MI) Myocardial Infarction demonstrated by new pathological Q waves on ECG 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary Non Q-wave myocardial infarction (MI) Myocardial Infarction not demonstrated by new pathological Q waves on ECG 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary Any myocardial infarction (MI) 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary Target vessel myocardial infarction (TV MI) 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary Spontaneous myocardial infarction (MI) 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary Procedural myocardial infarction (MI) Evaluated at 48 hours
Secondary Cardiovascular mortality 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary All-cause mortality 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary Cardiovascular mortality or myocardial infarction (MI) 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary All-cause mortality or MI 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary All-cause mortality, myocardial infarction (MI) or target vessel revascularization (TVR) 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary Any probable or definite stent thrombosis Evaluated at 48 hours
Secondary Probable stent thrombosis Defined as per the Academic Research Consortium (ARC) criteria 30 days and at 6, 12, 24, 36, 48, and 60 months
Secondary Definite stent thrombosis Defined as per the Academic Research Consortium (ARC) criteria 30 days and at 6, 12, 24, 36, 48, and 60 months
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