RecruitingIn-Stent RestenosisCardiovascular DiseasesCoronary Artery Disease

MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions

Eligible age

18–110 yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

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About this study

A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis. Subjects with prior DES implantation presenting with ISR lesions undergoing PCI will be randomized into two groups: treatment with the MagicTouch™ sirolimus-coated balloon or POBA on a 2:1 basis. Approximately 492 subjects will be enrolled in the randomized study in a maximum of 50 study sites located in the United States. The goal is to establish the safety and efficacy of the MagicTouch™ sirolimus- coated balloon in treatment of coronary in-stent restenosis (ISR).

Sponsor: Concept Medical Inc.

You may qualify if…

✓ 1. Subject is at least 18 years old
✓ 2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
✓ 3. Patient with an indication for PCI due to suspected in-stent restenosis
✓ 4. Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:
✓ Angiographic Inclusion Criteria:
✓ 1. In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)
✓ 2. Target lesion must have visually estimated stenosis ≥50% and less than 100% diameter stenosis in symptomatic patients; or a visually estimated target lesion diameter stenosis of ≥70%, or by evidence of ischemia by coronary physiology (fractional flow reserve \[FFR\] ≤0.80 or non-hyperemic pressure ratio \[NHPR\] ≤0.89) in absence of symptoms
✓ 3. Successful lesion preparation (residual stenosis \<30%), without complications (no or slow flow, flow-limiting dissection, perforation, distal embolization) and without plan for stenting

You may not qualify if…

✕ General Exclusion Criteria (all must be absent for the patient to be eligible):
✕ 1. STEMI within 72 hours of presentation to the first treating hospital, whether a transfer facility or the study hospital
✕ 2. NSTEACS in whom the biomarkers have not peaked
✕ 3. PCI within the 24 hours prior to the index procedure (not including PCI performed in non-target lesions during the index procedure)
✕ 4. Prior DCB treatment (coronary or off-label peripheral) of target lesion ISR
✕ 5. Cardiogenic shock (defined as persistent hypotension \[systolic blood pressure \<90 mm Hg\] or requiring vasoactive or hemodynamic support, including IABP)
✕ 6. Subject is intubated
✕ 7. Known left ventricular ejection fraction \<30%