MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels

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.

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.

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.

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.