Using a special balloon to treat small coronary artery blockages

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, single-blind study evaluates the safety and efficacy of the MagicTouch™ sirolimus-coated balloon for treating small coronary artery lesions in patients with coronary artery disease. A total of 1605 subjects will be enrolled across up to 50 sites in North America, with additional sites in Europe and South America. Participants will be randomized to receive either the MagicTouch™ balloon or a standard drug-coated balloon during a percutaneous coronary intervention. The primary endpoint is the rate of target lesion failure at 12 months post-intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clearwater Cardiovascular and Interventional Consultants
  Clearwater, Florida, United States Recruiting
• Atlanticare Regional Medical Center
  Pomona, New Jersey, United States Recruiting
• Icahn School of Medicine at Mount Sinai/ Mount Sinai Hospital
  New York, New York, United States Recruiting
• Montefiore Medical Center
  The Bronx, New York, United States Recruiting
• Baylor Scott & White The Heart Hospital - Plano
  Plano, Texas, United States Recruiting
• Dignity Health - Mercy Gilbert Medical Center
  Gilbert, Arizona, United States Not yet recruiting

Study contacts

• Study coordinator: Farhana Siddique
• Email: farhana@conceptmedical.com
• Phone: +919725495366

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.