MagicTouch Sirolimus-Coated Balloon in Coronary Artery Lesions of In-Stent Restenosis

What is the Purpose of this Study?

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug-coated balloon system called the MagicTouch sirolimus-coated balloon for the treatment of coronary in-stent restenosis (recurrence of narrowing of a blood vessel). Study procedures include a coronary intervention procedure with either the MagicTouch sirolimus-coated balloon or POBA (plain old balloon angioplasty, the standard of care). Participants are individuals who have heart arteries that are narrowed or blocked and need treatment to help open up the blockage. A drug-eluting stent is a device that releases a drug which helps prevent blockages from recurring. Drug-coated balloon devices such as the MagicTouch Sirolimus-Coated Balloon are like POBA but are coated with a drug that helps to prevent restenosis and may thus be a new option for treating restenosis. All participants will undergo treatment of narrowed regions in prior drug-eluting stent with plain old balloon angioplasty. Some patients will be randomly assigned to receive treatment with the MagicTouch Sirolimus-Coated Balloon, which is composed of a balloon catheter coated with the sirolimus drug.

Eligibility

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:

Inclusion Criteria:

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:
1. In-stent restenosis after drug-eluting stent implantation(s) in the target lesion
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
4. Target lesion in a native coronary artery
5. Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion
6. Target reference vessel diameter (visual estimation) \>2.0 and ≤4.0 mm
7. Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and can be covered by only one balloon
8. One ISR target lesion (overlapping stents are allowed) to be treated per patient and in single major coronary artery or side branch (reference vessel diameter \>2.0 mm)
9. Other coronary lesions (ISR or non-ISR) in non-target vessel are allowed and may be treated by any approved interventional device, but must be treated successfully prior to randomization

Exclusion Criteria:

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. Cardiogenic shock (defined as persistent hypotension \[systolic blood pressure \<90 mm Hg\] or requiring vasoactive or hemodynamic support, including IABP)
5. Subject is intubated
6. Known left ventricular ejection fraction \<30%
7. Relative or absolute contraindication to DAPT for at least 1 month (e.g., planned surgeries that cannot be delayed)
8. Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
9. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
10. Hemoglobin \<9 g/dL
11. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
12. White blood cell count \<3,000 cells/mm3
13. Active infection undergoing treatment
14. Clinically significant liver disease
15. Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be \<30ml/min by the MDRD formula
16. Active peptic ulcer or active bleeding from any site
17. Bleeding from any site requiring active medical attention within the prior 8 weeks
18. History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions
19. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA
20. Known allergy to the study device components or protocol-required concomitant medications:
- sirolimus (as well as other limus drugs, analogues, or similar compounds), aspirin, clopidogrel and prasugrel and ticagrelor, heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated
21. Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduce life expectancy to \<24 months (e.g. cancer, heart failure, lung disease, severe valvular disease)
22. Patient is participating in or plans to participate in any other investigational drug or device trial that has not reached its primary endpoint
23. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before index procedure)
24. Women who intend to become pregnant within 12 months after the index procedure
25. Patient has received an organ transplant or is on a waiting list for an organ transplant
26. Patient has received chemotherapy within 30 days before the index procedure or scheduled to receive chemotherapy any time after the index procedure
27. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease. Inhaled steroid and steroid use for contrast- allergy prophylaxis or treatment are allowed
1. More than 1 ISR lesion in the target vessel in segments that cannot be treated by a single 40 mm length DCB (see Angiographic Inclusions #5 and #6 above)
2. Unprotected left main lesions \>50% or left main intervention
3. Primary PCI for STEMI
4. Coronary artery disease judged more suitable for surgical revascularization per guidelines and local heart team discussion
5. Another lesion in either the target vessel or non-target vessel is present that requires or has a high probability of requiring PCI within 12 months after the index procedure
6. Prior brachytherapy or DCB treatment of target lesion
7. Target lesion is a bifurcation restenosis involving both branches of a bifurcation in which the side branch reference vessel diameter is \>2.0 mm
8. Target lesions located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
9. Target lesion contains large thrombus
10. Target lesion is heavily calcified
11. Target lesion is a chronic total occlusion
12. Diffuse distal disease to target lesion with impaired runoff

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

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

Study Details

Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III/IV

IRB Number

STUDY00003120

ClinicalTrials.gov ID

NCT05908331

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org